ABSTRACT
摘要
Objectives: In this randomized split-mouth clinical trial the survival rate and quality of survival of indirect resin composite and ceramic laminate veneers were evaluated.
研究目的：在這項隨機分隔口腔 (split-mouth) 的臨床試驗中，評估複合樹脂修復材料和陶瓷貼片的存活率和存活品質。
Methods: A total of 48 indirect resin composite (Estenia; n = 24) and ceramic laminate veneers (IPS Empress Esthetic; n = 24) were placed on maxillary anterior teeth. Veneer preparations with incisal overlap were performed using a mock up technique. Survival of the restoration was considered the primary outcome measure and reported using Kaplan-Meier statistics and survival curves compared by means of Log Rank (Mantel-Cox) test. After luting, restorations were evaluated by calibrated operators at baseline and every year thereafter, using modified USPHS criteria and compared by means of Mann-Whitney U test.
方法：在上排前牙共 48 顆牙齒上使用複合樹脂修復材料（Estenia, C&B Kuraray 出廠的複合樹脂；樣本數 (n) = 24）和陶瓷貼片（IPS Empress Esthetic；n = 24）。使用口內預覽 (mock up) 技術來進行切緣包覆的貼片製備。復形體的存活率被認為是主要評估指標，並使用 Kaplan-Meier 統計方法和等級檢定 (Mantel-Cox) 來比較存活曲線。黏合之後，由校驗者在基線和此後的每一年，使用修正後的美國公共衛生局 (USPHS) 標準來評估復形體，並以曼－惠特尼 U 檢定 (Mann-Whitney U test) 進行比較。
Results: In total, 6 failures were observed, consisting of debonding (n = 3) and fracture (n = 3), all in the group of the indirect resin composite laminate veneers. Cumulative chance on survival after 10 years of the indirect resin composite and ceramic veneers was 75% (se 3,8%) and 100% respectively (p = 0.013). Of the surviving 42 laminate veneers, the variables ‘color match’ (p = 0.002), ‘surface roughness’ (p = 0.000), ‘fracture of the restoration’ (p = 0.028), and ‘wear of the restoration’ (p = 0.014), were significantly less favourable among the composite laminate veneers as well.
結果：總共觀察到 6 次失敗經驗，包括鬆脫 (n = 3) 和斷裂 (n = 3)，均發生在複合樹脂修復貼片群組中。複合樹脂修復材料和陶瓷貼片的 10 年後累積存活機率分別為 75%（標準誤差 (se) 3.8%） 和 100% （條件機率 (p) = 0.013）。在存活的 42 個貼片中，變色 (p = 0.002)、表面變得粗糙 (p = 0.000)、復形體斷裂 (p = 0.028) 和復形體磨損 (p = 0.014) 等不利情形，也明顯在複合樹脂材料貼片中發生。
Conclusions: The ceramic veneers on maxillary anterior teeth in this study performed significantly better compared to the composite indirect laminate veneers after a decade, both in terms of survival rate and in terms of quality of the surviving restorations.
結論：本研究中上排前牙陶瓷貼片和複合樹脂修復貼片相比，十年後的存活率和存活復形體品質的表現明顯較好。
Clinical Relevance: When indicated, anterior ceramic laminate veneers may be preferred over indirect composite laminate veneers.
臨床意義：研究顯示，前牙陶瓷貼片可能比複合樹脂修復更好。
1. Introduction
Laminate veneer restorations are indicated for different esthetic reasons as a minimal invasive treatment concept. Based on the literature there is no consent as to which material should be used as the restorative material, composite or ceramic [1,2]. Some attempts have been made to compare these materials in vivo, however, no comparison was made in vivo in a split mouth environment with over 10 years of follow up [1,3].
1. 前言
基於不同的美學需求，復形體貼片和樹脂均被認為是一種微創的治療。根據現有文獻，對於應使用複合樹脂或陶瓷 [1,2] 來作為修復材料尚無定論。然而到目前為止，在超過 10 年的追蹤裡，並沒有在人體內的分隔口腔環境中進行比較 [1,3]。
Survival rates of ceramic laminate veneers range between 82–96% after 10–21 years [4–9]. Fracture of ceramic material (5.6–11%) and marginal defects (12–20%) were the main reasons of failure [4,6,10–14]. Success rates are reported to decrease due to poor marginal quality and discoloration which contained 18–25% up to 10 years of function.
10 至 21 年後的陶瓷貼片存活率範圍約在 82% 到 96% 間 [4–9]。陶瓷材料斷裂 (5.6–11%) 和邊緣缺陷 (12–20%) 是失敗的主因 [4,6,10–14]。根據先前研究，成功率因為邊緣品質不佳和變色而降低，在長達 10 年的使用期後，會有 18–25% 出現以上情形。
Indirect composite restorations are easy to lute and repair, have higher flexural modulus, are cost effective and less abrasive to the antagonistic teeth [15]. Contemporary particulate filler composites (Estenia, Kuraray Co., Tokyo, Japan) contains up to 92 wt% colloidal silica spheres with 16 wt% superfine microfillers, grain size of 0.02 μm, and 76 wt% microfillers, grain size of 2 μm in urethane tetramethacrylate (UTMA) resin matrix. Previous indirect composite resin materials contained merely 50–80 weight% of fillers [16,17]. In addition, UTMA resin matrix which contains four functional urethane methacrylates resulting in a higher crosslinking density than other materials [17]. The higher filler content increases both strength and optical properties, but make the material more brittle as well.
複合樹脂修復復形體容易黏合及修補，有較高的彎曲模量、具有成本效益、對對咬牙的磨損較小 [15]。現在的粒子填充複合樹脂材料（Estenia，Kuraray 公司，日本東京市）含有高達 92 wt% 的二氧化矽膠體球和 16 wt% 的超細微粒子填料，晶粒大小為 0.02 μm，以及 76 wt% 的超微填料，在胺基甲酸乙酯四甲基丙烯酸酯 (urethane tetramethacrylate, UTMA) 樹脂基質中的晶粒大小為 2 μm。以往的複合樹脂修復材料僅含有 50–80% 的填料 [16,17]。此外，UTMA 樹脂基質含有四種功能性胺基甲酸乙酯甲基丙烯酸酯 (urethane methacrylate)，因此交聯密度比其他材料有更高[17]。填料含量越高，強度會越高，光學性能也越好，但也會使材料更易碎。
Direct comparison between different material options for laminate veneers were only performed in few studies with relatively short followup periods. Therefore, the Cochrane Collaboration concluded that there is no evidence as to which material performs better [2]. In an in vivo study by Meijering et al. [1] different materials were compared for laminate veneers; direct composite, indirect composite and ceramic. Survival rates were 6%, 13% and 0% respectively after a mean follow up period of 1.7 years. Relative failures were not different among the indirect composite and ceramic restorations. In a split mouth randomised clinical trial with 3 years of follow up similar failure rates were obtained for indirect resin composite laminate veneers (13%) [3]. Relative failures were seen but not considered significant between the two materials either, except for surface roughness [3].
僅有少數的文獻針對不同材料的前牙修復方式進行直接比較，且追蹤期較短。因此，考科藍合作組織 (Cochrane Collaboration) 認定，並沒有證據顯示哪一項材料的效果較好[2]。在 Meijering 等人執行的人體內試驗 [1] 中，針對直接複合樹脂材料、複合樹脂修復材料和陶瓷三種不同材料的貼片進行比較。在平均追蹤期 1.7 年後，存活率分別為 6%、13% 和 0%。樹脂修復復形體和陶瓷復形體的相對失敗率沒有差異。在一項追蹤期為 3 年的分隔口腔隨機臨床試驗中，複合樹脂修復貼片的失敗率相似 (13%) [3]。除了表面粗糙度 [3] 外，兩種材料之間有相對失敗率但並不顯著。
Due to aging of dental materials, differences between materials could be expected. Exposure to smoking, food, acidic beverages, temperature changes, function of the teeth, saliva and biofilm will affect various materials differently. Although composite materials are known for their degradation, ceramic or the glaze layer of the ceramic will also deteriorate over time due to acidic influences and functional wear [18,19]. Degradation of the surface polish or smoothness will not only affect the esthetic appearance, but also biofilm accumulation [20] and wear of surrounding or opposing teeth [21–23].
由於牙材老化，材料會出現可預期的變化。接觸香菸、食物、酸性飲料、溫度變化、牙齒功能、唾液和牙菌斑會對各種材料產生不同的影響。雖然已知複合樹脂材料會分解，但由於酸性物質的影響和功能，陶瓷或其釉層也會隨著時間演進而退化 [18,19]。表面拋光或光滑度的衰退不僅會影響美觀，還會影響生物膜累積 [20] 並磨損鄰牙或對側牙[21–23]。
The objective of this randomized clinical trial was to evaluate the clinical performance of maxillary anterior laminate veneers made of particulate filled composite and ceramic in a split-mouth design after a mean observation period exceeding 10 years of clinical service. Primary outcome parameter was survival of the restoration, secondary outcome parameter was the quality of survival. The null hypothesis tested was that both laminate materials would function similarly.
這項隨機臨床試驗的目的是在評估樹脂修復和陶瓷貼片在口腔內長達 10 年的服務後的臨床表現。主要結果參數是復形體的存活率，次要結果參數是存活品質。進行測驗的虛無假設是兩種貼片材料的功能相似。
2. Materials and methods
2.1. Study design
This is the follow up study of data presented in our previous article [3]. To avoid possible disturbing differences in case when distinct degrees of tooth discoloration would occur between restorations of different materials, a modified split mouth design was employed in which the central incisors and the symmetrical other teeth received the same type of restoration. Randomization was performed using the flip of a coin for the choice of material. For this observational study the STROBE guidelines were followed.
2. 材料與方法
2.1. 試驗設計
本研究為根據上一篇研究 [3] 所提供的數據之後續研究。為了避免不同材料的復形體間可能出現不同程度的牙齒變色而造成干擾，採用改良的分隔口腔設計，其中正中門齒和其他互相對稱的牙齒使用相同類型的復形體。透過擲硬幣來隨機選擇材料。這項觀察型研究遵循 STROBE 準則。
2.2. Inclusion and exclusion criteria
Potential candidates were at least 18 years old, able to read and sign the informed consent document, physically and psychologically able to tolerate conventional restorative procedures, having no high caries risk, periodontal or pulpal diseases, having teeth with good restorations, require esthetic improvement of at least 2 anterior teeth, not allergic to resin-based materials, not pregnant or nursing, and willing to return for follow-up examinations as outlined by the investigators. Between June 2008 and November-2010, a total of 11 patients ranging in age between 20 and 69 years (8 female, 3 male, mean age: 54.5 years) could be recruited and received 48 indirect composite (n = 24) and ceramic laminate veneers (n = 24). Alternative treatment options were discussed. All patients provided informed consent as required by the ethical committee of the University Medical Centre Groningen review board (Clinical Trial identification number: NCT03145597).
2.2. 納入和排除條件
有機會參與的受試者須至少年滿 18 歲，能夠閱讀和簽署受試者同意書，在生理和心理上能夠承受經常修復程序，沒有高齲齒風險、牙周或牙髓疾病，有良好的牙齒復形體，至少有 2 顆前牙需要美化，對樹脂基質的材料不會過敏，沒有懷孕且非正在哺乳，並願意回來進行研究人員概述的追蹤檢查。2008 年 6 月至 2010 年 11 月間共招募 11 名年齡介於 20 至 69 歲的患者（8 名女性和 3 名男性，平均年齡為 54.5 歲）接受 48 種複合樹脂修復材料 (n = 24) 和陶瓷層貼片(n = 24)，以及討論替代治療選項。所有患者均按照格羅寧根大學醫學中心倫理審查委員會的要求提供受試者同意書（臨床試驗識別號：NCT03145597）。
2.3. Tooth preparation
Treatment planning was performed using digital photos, and stone casts. Shade was determined using different shade tabs under standard conditions (6500 K, 8 light intensity, Longlife, Aura, The Netherlands) in the dental laboratory. A wax set-up was made on the plaster model using the mock-up technique [9]. The wax set-up was used to communicate on the correction of the form and position of the teeth and also to evaluate the expectations of the patient.
2.3. 牙齒製備
使用數位照片和石膏模型進行治療計畫。在牙科技工所中，在標準條件（6500 K，8 光強度，Longlife，Aura，荷蘭）下使用不同的色板確定色調。使用口內預覽技術在石膏模型上製作蠟型 [9]。蠟型用於呈現牙齒位置和矯正的型態，以及評估患者的期待。
Magnifying microscope (x3.4–21.3) (Opmipico, Zeiss, Sliedrecht, The Netherlands) was used for minimal preparations. Ball-shaped diamond burs (ISO 801 018, Diatech, Altstätten, Switzerland) were used to mark preparation depths through the set-up. The labial surfaces were axially reduced by 0.3–0.5 mm. Tapered round-ended diamond burs (ISO 856 018, Diatech) were used for uniform preparations. An incisal overlap of 1–1.5 mm was prepared on all cases. At the cervical area, a shallow chamfer finish line (0.5 mm) was created equi- or supra-gingival to maintain good periodontal health. A shallow chamfered marginal finish line extended inter-proximally to hide the restoration margins up to contact area.
顯微鏡（放大倍數 3.4–21.3）（Opmipico，Zeiss，荷蘭斯利德雷赫特）用於簡化製備流程。使用球形鑽石針（ISO 801 018，Diatech，瑞士阿爾特施泰滕鎮）來標記整個排牙的製備深度。唇側軸向修磨了 0.3–0.5 毫米。錐形圓頭鑽石針 (ISO 856 018，Diatech) 用於統一製備流程。所有病例中都製備了 1–1.5 毫米的切緣包覆。在頸齒區域，在牙齦或牙齦上建立一個淺弧形完成線（0.5 毫米），以保持良好的牙周健康。一條淺弧形邊緣完成線在鄰接面延伸，以隱藏復形體邊緣直至接觸區域。
All internal angles were smoothed to reduce stress concentration. On the palatal aspect, a right-angled contour (butt joint) between the incisal edge and the palatal surface was achieved. Impressions were then made using a polyether impression material (Impregum, 3 M ESPE, St. Paul, MN, USA). Temporary veneers were made chair-side using a spot-etch technique and auto-polymerized bis-acryl (Structur SC, Voco, Cuxhaven, Germany).
所有內角 (internal angles) 皆已磨平以減少應力集中現象。在腭側，切緣和腭面之間呈直角（方形接合），接著使用聚乙醚印模材料（Impregum, 3M ESPE, 美國明尼蘇達州聖保羅市）製作印模。使用單點酸蝕技術和自動聚合的雙酚丙烯酸 (bis-acryl)（Structur SC，沃柯有限公司，德國庫克斯港市）在治療椅側製作臨時貼片。
One dental technician made all laminate veneers. Leucite reinforced glass ceramic (IPS Empress Esthetic, Ivoclar Vivadent, Schaan, Liechtenstein) were processed according to the manufacturer’s instructions using the IPS Empress layering and lost wax technique. After wax-up, a cut-back of 0.2–0.8 mm was performed to allow for layering of the veneering ceramic.
同一位牙醫技師製作全部的貼片。根據製造商的說明來處理白榴石強化玻璃陶瓷（IPS Empress Esthetic，Ivoclar Vivadent，列支敦士登公國沙恩區），使用 IPS Empress 分層和去蠟技術進行加工。築蠟後回切 0.2 至 0.8 毫米，以製造貼片陶瓷分層效果。
The indirect composite laminate veneers (Estenia C&B, Kuraray, Tokyo, Japan) were fabricated using the layering technique following the manufacturer`s instructions. They were heat- (100–110 °C for 15 min) and photo-polymerized (400–515 nm for 270 s) using a special polymerization device (Heat-curing-110, Toesco, Yoshida, Japan) according to the manufacturer’s recommendations.
複合樹脂修復貼片（Estenia C&B，Kuraray，日本東京市）是遵循製造商的說明，使用分層技術製成的。根據製造商的建議，使用一種特殊的聚合設備（Heat-curing-110，Toesco，Yoshida，日本）進行加熱（100–110 °C，15 分鐘）和光聚合（400–515 奈米，270 秒）。
Both ceramic and resin composite laminate veneers were hand polished using diamond burs and silicone rubber points (3044HP30044HP Ceragloss, Edenta, St. Gallen, Switzerland) and diamond pastes with brushes (Estenia C&B polishing compound and Yeti Diaglaze).
陶瓷和複合樹脂貼片均使用鑽石針、矽橡膠錐（3044HP30044HP Ceragloss，Edenta，瑞士聖加侖市）和鑽石膏及鑽石刷（Estenia C&B 拋光劑和 Yeti Diaglaze）進行人工拋光。
2.4. Luting
Form, adaptation and shade match of the restorations were checked clinically using try-in pastes (Variolink Veneer Try-in Paste, Ivoclar Vivadent).
2.4. 黏合
臨床上使用試色劑 (Variolink Veneer Try-in Paste，Ivoclar Vivadent) 檢查復形體的形狀、密合度和比色。
After cleaning with 99% isopropanol, intaglio surfaces of the laminates were etched with 4.9% hydrofluoric acid (IPS Ceramic etching gel, Ivoclar Vivadent) for 1 min, washed thoroughly for 1 min and dried with oil-free compressed air. Since etching with hydrofluoric acid leaves a significant amount of crystalline debris precipitate at the ceramic surface,4 laminate veneers were ultrasonically cleaned in distilled water for 5 min. Thereafter, the adhesive surfaces were silanized (Monobond S, Ivoclar Vivadent) for 1 min. After silanization, adhesive resin (ExciTE, Ivoclar Vivadent) was applied, air-thinned but not polymerized.
用 99% 異丙醇清洗後，貼片的凹面用 4.9% 氫氟酸（IPS 陶瓷酸蝕膠，Ivoclar Vivadent）處理 1 分鐘、徹底清洗 1 分鐘，並用無油空壓機乾燥處理。由於氫氟酸蝕刻會在陶瓷表面留下大量結晶碎片沉澱4，因此將貼片在蒸餾水中超音波清洗 5 分鐘。之後再將黏合面矽烷化 (Monobond S, Ivoclar Vivadent) 1 分鐘。矽烷化處理後，使用黏合樹脂 (ExciTE, Ivoclar Vivadent) 吹薄處理但不聚合。
The intaglio of the indirect composite laminate veneers was tribo-chemically silica coated (30 μm SiO2, CoJet-Sand, 3 M ESPE) using an intraoral air-abrasion device (Dento-Prep, RØNVIG A/S, Daugaard, Denmark) at a pressure of 2.5 bar from a distance of approximately 10 mm for 20 s. They were then silanized with 3-methacryloxypropyl-trimethoxy silane coupling agent (MPS) (ESPE-Sil, 3 M ESPE AG) and waited for its evaporation for 5 min. After silanization, adhesive resin (ExciTE, Ivoclar Vivadent) was applied, air-thinned but not polymerized.
使用口腔內噴砂裝置（Dento-Prep，RØNVIG A/S，Daugaard，丹麥）對複合樹脂修復貼片的凹面進行磨潤化學二氧化矽披覆 (30 μm SiO2，CoJet-Sand，3M ESPE)，從大約 10 毫米的距離持續施加 2.5 巴的壓力 20 秒。然後用 3-甲基丙烯酸氧基三甲氧基矽烷耦合劑 (MPS) (ESPE-Sil, 3M ESPE AG) 將它們矽烷化，並等 5 分鐘使其蒸發。矽烷化處理後，使用黏合樹脂 (ExciTE，Ivoclar Vivadent) 吹薄處理但不聚合。
All teeth to be veneered were isolated using a split-rubberdam technique. Contour strips (Contour-Strip, Ivoclar Vivadent) were placed interproximal to perform a smooth restoration outline in the approximal-cervical area. The prepared teeth were first cleaned with fluoride-fee pumice (Pumice Flour, Dux, Utrecht, The Netherlands) using a polishing brush (Polishing brush, Coltène/Whaledent, Altstatten, Switzerland).
使用分隔橡皮障技術隔離所有要貼上貼片的牙齒。將透明隔片 (Contour-Strip，Ivoclar Vivadent) 放置在鄰面，以在鄰接齒頸區進行平整輪廓修復。首先使用拋光刷 （Polishing Brush，Coltène/Whaledent，瑞士阿爾特施泰滕鎮）和不含氟的滑石粉（Dux，荷蘭烏特勒支市）清潔製備好的牙齒。
Enamel and dentin were etched with 37% H3PO4 (Total Etch, Ivoclar Vivadent, Schaan, Liechtenstein) for 15–30 seconds. After rinsing for 30 s and air-drying, the adhesive resin (ExciTE, Ivoclar Vivadent) was then applied on both the tooth and the restoration surfaces with a microbrush for 15 s, air-thinned but not polymerized.
牙釉質和牙本質用 37% H3PO4 溶液（Total Etch，Ivoclar Vivadent，列支敦士登公國沙恩市）蝕刻 15 至 30 秒。沖洗 30 秒並風乾，之後將黏合樹脂 (ExciTE，Ivoclar Vivadent) 用小毛刷塗在牙齒和復形體表面 15 秒，吹薄處理但不聚合。
Laminate veneers were luted using a photo-polymerizing resin composite cement (Variolink Veneer, Ivoclar Vivadent). Composite was applied to the inner surface of the laminates. After placement, initially, they were photo-polymerized with an LED lamp (Bluephase 20i, Ivoclar Vivadent) for only 3 s at the buccal surface to ensure stabilization of the veneer. The light output was at least 800 mW/cm2 in all applications. Gross excess composite at the margins was removed immediately with the aid of brushes, scalers and dental floss (Oral-B, Rotterdam, The Netherlands). Application of glycerine gel (Liquid-Strip, Ivoclar Vivadent) at the margins ensured oxygen inhibition during polymerization. Buccal, oral, and proximal surfaces were further polymerized for 40 s. After rinsing the glycerine gel, excess material was removed with hand-instruments and finishing burs. Restoration margins were further polished with silicone polishers (Astropol FP, HP, Ivoclar Vivadent) and interproximal polishing strips (Soft-Lex Finishing Strips, 3 M ESPE) at 7.500–10.000 rpm under water. One clinician placed all restorations. Finally, the occlusion was checked in protrusive and lateral movements of the mandible. The goal was to reach anterior guidance and lateral protection in all cases. Patients were given information on how to clean the restorations and teeth, on diet (no restrictions with food or drinks), no nail biting and parafunctional habits (providing a night guard).
使用光聚合複合樹脂黏合劑 (Variolink Veneer，Ivoclar Vivadent) 黏合貼片。複合樹脂材料用在貼片的內側表面。放置後，起初在頰側表面用 LED 燈 (Bluephase 20i，Ivoclar Vivadent) 使其光聚合僅 3 秒，確保貼片的穩定性。不管用什麼光源，光輸出至少為 800 mW/cm2。之後立即使用刷子、洗牙機和牙線（Oral-B, 荷蘭鹿特丹市）去除邊緣多餘的複合樹脂材料。在邊緣處塗抹甘油凝膠 (Liquid-Strip，Ivoclar Vivadent)，以確保在聚合過程中隔離氧氣。頰側、口腔和鄰接面進一步聚合 40 秒。沖洗甘油凝膠後，用手動工具和修整針去除多餘的材料。使用矽膠拋光機 (Astropol FP、HP、Ivoclar Vivadent) 和鄰面拋光條 (Soft-Lex Finishing Strips, 3M ESPE) 在水中以 7.500–10.000 rpm 的速度進一步於復形體邊緣進行拋光。一名臨床醫生放入所有的復形體。最後，在下頜骨的前突和側向運動中檢查咬合。目標是在所有情況下都達到前牙導引和側向保護。向患者提供有關如何清潔復形體和牙齒、飲食（不限於食物或飲料）、不咬指甲和避免異常功能的習慣（提供夜間防磨牙牙套）的資訊。
2.5. Evaluation
Restorations were clinically evaluated at baseline and thereafter by two calibrated observers who were blinded to the objective of this study. Caries, debonding and fracture to failure were considered as absolute failures. Patients were also questioned about possible postoperative complaints. Both observers evaluated the restorations independently, according to the modified United States Public Health Service (USPHS) criteria (Table 1). The restorations were visually inspected with dental mirror and probe. After data collection, in case of discrepancies in scoring, restorations were evaluated again, a consensus was reached and this was accepted as the final score. Patients were instructed to call upon any kind of failure. Digital pictures (1:1) were made after placement of the veneers and during follow-up sessions. In representative cases, an impression (Ultra-Light and Heavy body Aquasil, Dentsply) was taken from the two laminate veneers after cleansing the surface with absorbent paper and sodium hypochlorite 0.5%. Impressions were poured with cold mounting epoxy resin (Epoxy-Cure, Buehler, IL, USA) then sputter-coated with a 3 nm thick layer of gold (80%) / palladium (20%) (90 s, 45 mA; Balzers SCD 030, Balzers, Liechtenstein) and analyzed using cold field emission Scanning Electron Microscope (SEM) (LyraTC, Tescan, Brno, Czech Republic). Images were made at 15 kV at a magnification of x22 to x2.500.
2.5.評估
在基線時進行復形體的臨床評估，之後由兩名對本試驗目的不知情的校準觀察員進行評估。齲齒、鬆脫和斷裂視為絕對失敗。並詢問患者手術後可能有的抱怨。根據修正後的美國公共衛生局 (USPHS) 標準（表 1），兩位觀察員獨立評估復形體。用牙科鏡和探針以目視檢查復形體。收集數據後，如果評分存有差異，則再次評估復形體，達成共識並將其作為最終評分。患者被指示檢視任何類型的失敗。在貼片放置後和追蹤期間製作數位照片 (1:1)。在代表性個案中，在以吸水紙和 0.5% 次氯酸鈉清潔表面後，從兩個貼片中取出印模 (Ultra-Light and Heavy body Aquasil, Dentsply)。用冷鑲埋環氧樹脂（Epoxy-Cure，Buehler，美國伊利諾州）澆注印模，然後濺鍍 3 nm 厚的金 (80%)/鈀 (20%)（90 秒，45 毫安；Balzers SCD 030, 列支敦士登公國巴爾策斯區） 並使用冷場發射掃描式電子顯微鏡 (SEM)（LyraTC, Tescan, 捷克共和國布爾諾市）進行分析。圖像是在 15 kV 下放大 22 至 2.500 倍製作的。
2.6. Statistical analysis
Survival analyses were performed with statistical software program (SPSS 23.0; SPSS Inc, Chicago, IL, USA) using Kaplan-Meier and Log Rank (Mantel-Cox) tests to obtain the overall survival rate in relation to observation time. A nonparametric test (Mann-Whitney U test) was performed for the qualitative evaluation of the data. An alpha level of 0.05 for all statistical tests was set.
2.6. 統計分析
使用 Kaplan-Meier 統計方法和等級檢定 (Mantel-Cox) 檢驗，在統計軟體程式（SPSS 23.0；SPSS Inc，美國伊利諾州芝加哥市） 進行存活分析，以取得與觀察時間相關的整體存活率。進行非參數檢測（曼－惠特尼 U 檢定 (Mann-Whitney U test)），以對數據進行定性評估。所有統計檢測的顯著水準值設定為 0.05。
Table 1 List of modified United States Public Health Service (USPHS) criteria used for the clinical evaluations of the laminate veneers.
表 1 用於貼片臨床評估的修正後的美國公共衛生局 (USPHS) 標準列表。
3. Results
5 Recalls were performed after baseline measurements and no drop-outs occurred, yielding to the evaluation of 48 indirect laminate veneers (Estenia: n = 24; IPS Empress Esthetic: n = 24)(Fig. 1). After including 11 patients, it was decided to stop the further inclusion of patients due to failures and differences seen in longevity between both groups. The mean observation time was 97 months with a minimum observation period of 89 months (n = 4) and up to a maximum of 120 months (n = 4). The distribution of the location of the restorations was as follows: 20 on central incisors, 18 on lateral incisors, and 10 on canines. Average treatment time for each restoration was noted to be approximately 120 min, regardless the treatment type. Two patients received occlusal splints after cementation, indicated because of parafunctional habits.
3. 結果
在基線測量後召回 5 位受試者，沒有人退出；從而針對 48 個樹脂修復貼片進行評估（Estenia：樣本數 (n) = 24；IPS Empress Esthetic：樣本數 (n) = 24）（圖 1）。在納入 11 名患者後，由於發現失敗及兩組之間的壽命差異，決定停止進一步納入患者。平均觀察時間為 97 個月，最短觀察期為 89 個月（樣本數 (n) = 4），最長觀察期為 120 個月（樣本數 (n) = 4）。復形體位置分佈如下：正中門齒 20 顆，側門齒 18 顆，犬齒 10 顆。無論治療類型為何，每個復形體的平均治療時間約為 120 分鐘。兩名患者在黏合後接受了咬合板，顯示原因為異常功能的習慣。
The cumulative chance of survival was 75% (se 3,8%) and 100% for the indirect composite land ceramic laminate veneers respectively after 10 years (120 months). Survival curves showed a statistically different distribution (p = 0.013) [Kaplan-Meier, Log Rank (Mantel-Cox) (Cl = 95%)] (Fig. 2). A total of 6 absolute failures were observed, all in the in the group of the indirect resin composite veneers in the form of debonding (n = 3) or fracture (n = 3). The debondings were a complete adhesive failure between the tooth and the luting cement, which occurred 11–25 months after cementation. Some of the composite remained attached to the inner surface of the laminate restoration. After cleaning the adhesive surface, the debonded veneers were rebonded but were not further evaluated and scored as a failure. All ractures occurred at the incisal area and were cohesive failures in the indirect composite material. The first fracture occurred on a tooth 11 (Fig. 4a), 13 months after delivery. The second laminate fracture occurred on a tooth 22 which was sound, 11 months after delivery. The third fracture occurred 6 years after placement after eating some bread.
10 年（120 個月）後，複合樹脂修復材料和陶瓷貼片的累積存活率分別為 75%（標準誤差 (se) 3.8%） 和 100%。生存曲線顯示出統計學上不同的分佈（條件機率 (p) = 0.013） [Kaplan-Meier 統計方法，等級檢定 (Mantel-Cox) （信賴區間 (Cl) = 95%）]（圖 2）。總共觀察到 6 個絕對失敗，均以鬆脫（樣本數 (n) = 3）或斷裂（樣本數 (n) = 3）的形式出現在複合樹脂修復貼片中。鬆脫是指牙齒和黏合劑之間無法完全黏合，發生在黏合後 11 至 25 個月。有些複合樹脂材料仍然附著在使用貼片的復形體內側表面上。在清潔黏合表面後，重新黏合鬆脫的貼片，但並不進一步評估或被判定為失敗。所有斷裂都發生在切緣區，並且是複合樹脂修復材料的膠合體失效。第一次斷裂發生在第 11 號牙齒上（圖 4a），貼片黏著後 13 個月。第二次貼片斷裂發生在第 22 號牙齒上，該牙齒在貼片黏著後 11 個月是完好的。第三次斷裂發生於貼片黏著 6 年後，患者吃了一些麵包後斷裂。
Fig. 1.
CONSORT flowchart presenting the inclusion and exclusion criteria and the final characteristics of the patients recruited to participate in this study.
圖 1。
試驗報告統一標準 (CONSORT) 流程圖顯示納入和排除標準，以及招募參加本試驗的患者的最終特徵。
Fig. 2.
Event-free survival rates of indirect resin composite and ceramic laminate veneers based on material up to 120 months (Estenia: 75% (se 3,8%); n = 24, events n = 6; IPS Empress Esthetic: 100%; n = 24, events n = 0).
圖 2 。
取決於材料的複合樹脂修復材料和陶瓷貼片的無事件存活率長達 120 個月(Estenia：75%(標準誤差 (se) 3,8%)；樣本數 (n) = 24，事件樣本數 (n) = 6；IPS Empress Esthetic：100%；樣本數 (n) = 24，事件樣本數 (n) = 0 )。
Table 2 Summaries of USPHS evaluations at baseline and final follow-up.
Criteria
Baseline Estenia (n=24) IPS Esthetic (n=24)
Final evaluation Estenia (n=18) IPS Esthetic (n=24)
Adaptation of Restoration
Color Match
Marginal Discoloration
Surface Roughness
Fracture of Restoration
Fracture of Tooth
Wear of Restoration
Wear of Antagonist
Caries
Post-operative Sensitivity
表 2 基線時和最後一次追蹤時的美國公共衛生局 (USPHS) 評估摘要。
標準
基線時 Estenia (n=24) IPS Empress Esthetic (n=24)
最終評估 Estenia (n=18) IPS Empress Esthetic (n=24)
復形體密合度
比色
邊緣變色
表面粗糙度
復形體斷裂
牙齒斷裂
復形體磨損
對咬牙磨損
齲齒
術後敏感度
Besides absolute failures, success was scored using the USPHS criteria (Table 2). Qualitative evaluation (success) showed some significance differences between laminates made of ceramic and indirect composite (Table 2). For all of these variables, the ceramic restorations were rated better. Of the 42 laminate veneers, minor voids and marginal discrepancies and defects were observed in 14 of the composite and 10 of the ceramic veneers (Adaptation-Score 1–2). Color match was significantly (Mann-Whitney U = 324, p = 0.002) different as the ceramic laminate veneers matched the surrounded teeth, composite restorations did not match for 8 laminate veneers (p = 0.002). Slight staining at the margins was seen more frequent with the composite laminate veneers (n = 12), however not significant (p = 0.107). Slightly rough surfaces (Surface roughness-Score 1) were significantly (Mann-Whitney U = 444, p = 0.000) more observed in the resin composite laminate veneer group (n = 18) until the final recall. These rough surfaces also experienced more plaque adhesion (Fig. 4b). Internal fractures without intervention were significantly (Mann-Whitney U = 292, p = 0.028) more seen (n = 6, p = 0.028) in the indirect composite group, chippings of tooth material were more seen in the composite group as well however this was not significant different (p = 0.06). Wear of the restoration was significantly (Mann-Whitney U = 303, p = 0.014) more seen in the indirect composite group (n = 7, p = 0.014). Secondary caries, endodontic complications or wear of the antagonist were not observed in any of the cases. In total, 8 teeth showed post-operative sensitivity at baseline, as reported by the patient. All post-operative sensitivities disappeared after 2 weeks; at the final recall 2 teeth were somewhat sensitive to cold. SEM and digital pictures were used for surface evaluation as can be seen in Fig. 3. This particular patient had her laminate veneers for 9 years and differences in surface change between the two materials can be clearly seen. Gloss retention was better with the ceramic restorations which is also seen at the SEM analysis. Patients were not aware of the loss of gloss due to saliva over the restorative materials (Fig. 5a-b)
除了絕對失敗之外，還使用美國公共衛生局 (USPHS) 標準對成功案例進行評分（表 2）。定性評估（成功）顯示由陶瓷和複合樹脂修復材料製成的貼片間存在一些顯著差異（表 2）。對於這些所有變量，陶瓷復形體的評分較高。42 個貼片中，在 14 個複合樹脂材料和 10 個陶瓷貼片（密合度評分為 1–2）上觀察到了輕微的縫隙、邊緣差異和缺陷。比色出現明顯差異（曼－惠特尼 U 檢定 (Mann-Whitney U test) = 324，條件機率 (p) = 0.002），陶瓷貼片與周圍牙齒顏色相符、8 個複合樹脂復形體與貼片顏色不相符（p = 0.002）。使用複合樹脂貼片（n = 12），邊緣處的輕微染色較常見（n = 12），但不顯著（p = 0.107）。在最後一次召回之前，複合樹脂材料貼片組 (n = 18) 中觀察到的輕微粗糙表面（表面粗糙度 — 分數 1）更為顯著（Mann-Whitney U = 444，p = 0.000）。這些粗糙的表面也有更多的牙菌斑附著（圖 4b）。在複合樹脂修復材料組中，未受干預的內部斷裂明顯（Mann-Whitney U = 292，p = 0.028）更常見（n = 6，p = 0.028），牙材破損也在複合材料組中更常見，但並沒有顯著差異（p = 0.06）。在複合樹脂修復組（n = 7，p = 0.014）中，復形體的磨損明顯更常發生（Mann-Whitney U = 303，p = 0.014）。在所有病例中均未觀察到繼發性齲齒、牙髓併發症或對咬牙磨損。根據患者的報告，共有 8 顆牙齒在基線時顯示有術後敏感性。2 週後所有術後敏感性消失；在最後一次召回時，有 2 顆牙齒對寒冷有些敏感。使用冷場發射掃描式電子顯微鏡 (SEM) 和數位照片進行表面評估，如圖 3 所示。該特定患者使用貼片 9 年，可以清楚地看到兩種材料之間表面變化的差異。在冷場發射掃描式電子顯微鏡 (SEM) 分析中，也可以看到陶瓷復形體的光澤保持度更好。患者並沒有意識到，修復材料上的唾液會導致失去光澤（圖 5a-b）。
4. Discussion
In this randomized split mouth clinical trial, a comparison of indirect resin composite and ceramic laminate veneers was performed. This is the first clinical trial on anterior indirect restorations using two different restorative materials with a mean follow up of more than 8 years. The split mouth study design used removes a lot of inter-individual variability from the estimates of the treatment effect. The results presented cover observations up to 120 months of clinical function. In total 90% of the laminates required no intervention which could be considered as clinically acceptable. However, based on the significant differences in different aspects of success as well as the differences in survival rates the null hypothesis that there is no difference between the two restorative materials was rejected. Ceramic veneers performed significant better than the indirect composite ones.
4. 討論
在這項隨機分隔口腔臨床試驗中，對複合樹脂修復材料貼片和陶瓷貼片進行比較。這是第一次使用兩種不同的修復材料進行前牙樹脂修復的臨床試驗，平均追蹤時間超過 8 年。所使用的分隔口腔試驗設計，可消除許多療效估計中的個體間差異。所呈現的結果包含長達 120 個月的臨床表現觀察結果。臨床上可接受的表現為 90% 的貼片不需要干預。然而，基於成功個案的各種顯著差異，以及存活率的差異，推翻了兩種修復材料之間沒有差異的零假設。陶瓷貼片的表現明顯優於複合樹脂修復貼片。
Fig. 3. a–d.
Example of a representative patient at 9 year follow up recall. A) The intra oral situation where the two central incisors are made of indirect composite and the laterals of ceramic. It can be clearly seen that the central incisors did not keep their gloss B) Overview of the central and lateral incisor using SEM C) A 2500 times magnification of the composite laminate veneer where the degradation can be clearly seen D) A 2500 times magnification of the ceramic surface where there is almost no degradation of the surface and remains smooth
圖 3. a-d。
9 年追蹤召回的代表性患者案例。A) 兩顆由複合樹脂修復材料和陶瓷製成的正中門齒口腔內情況。可以清楚地看到正中門齒失去光澤 B) 使用冷場發射掃描式電子顯微鏡 (SEM) 觀察正中門齒和側門齒 C) 複合樹脂貼片放大 2500 倍，可以清楚地看到降解 D) 陶瓷表面放大 2500 倍，幾乎沒有降解並保持光滑
Six absolute failures occurred in this study of which 3 failed within the first 13 months of the study. The first failure occurred within the first year following luting and was a delamination of a composite laminate veneer on a canine where the substrate was predominantly dentin. In the literature, it is suggested that laminates bonded to large surfaces of dentin have a compromised survival rate and in such a situation requires an immediate dentin sealing, which was not performed in our study [24–26]. Increased fractures and chippings were noticed up to 8 times in studies where laminate veneers were made in patients with bruxing habits [7,27]. In this study, instructions to the patients were given at insertion of the laminate veneers regarding habits like nail biting and tearing materials with teeth. Two patients were provided with a hard acrylic resin occlusal appliance as they were suspected nocturnal bruxers. Patients were informed that there was a risk of fracture if compliance was inadequate. Another fracture after 12 months of insertion is probably related to function during protrusive and lateral excursive movements over teeth. Two debondings of composite laminate veneers occurred in the same patient (25 months after insertion) where both central incisors had reveived endodontic treatment prior to our study and the substrate was predominantly dentin again. All debonded laminate veneers could be rebonded to freshly cut dentin removing only 0.1 mm of dentin, performing a three step dentin bonding adhesive (Optibond FL, Kerr, Orange USA) and using a direct resin composite (HFO, Micerium, Avegno, Italy) as a cement [28,29]. All laminate veneers functioned until the end of the study but were scored as failure and were not screened for follow up evaluations.
在這項試驗中發生 6 次絕對失敗，其中 3 次在試驗的前 13 個月內發生。第一次失敗發生在黏合後的第一年，是複合樹脂貼片從犬齒上剝離，而犬齒的基質主要是牙本質。在文獻中，有提到在牙本質上進行大面積的貼片黏合會降低存活率，在這種情況下，需要立即進行牙本質封閉，而本試驗沒有這樣做 [24–26]。為有磨牙習慣的患者製作貼片的試驗中，發現斷裂和破損情形高出 8 倍 [7,27]。在本試驗中，在放入貼片時，向患者提供了有關咬指甲和撕裂材料等習慣的指引。因有兩名患者可能有夜間磨牙習慣，故提供他們硬丙烯酸樹脂咬合器，並告知患者若不遵照指示使用，則可能有斷裂的風險；植入 12 個月後的另一次斷裂，可能與牙齒前突和側向運動時的功能有關。一名患者（植入後 25 個月）發生了兩次複合樹脂貼片鬆脫的情形，其中兩顆正中門齒在本試驗之前都接受了根管治療，且基材主要是牙本質。所有鬆脫的貼片都可以重新黏合到剛修形的牙本質上，去除僅 0.1 毫米的牙本質，進行牙本質黏合三步驟（Optibond FL，Kerr，Orange USA）並使用直接複合樹脂材料（HFO，Micerium，義大利阿韋尼奧市）作為一種黏著劑 [28,29]。所有貼片在試驗結束前都能發揮作用，但被評為失敗，沒有篩選進行後續評估。
Of the qualitative evaluation, most frequently observed differences were the surface degradation and diminished gloss retention of the indirect resin composite material. All ceramic restorations remained smooth and their gloss until the final follow up. Both materials were processed in the laboratory and manufactured following the manufacturers’ instructions by an experienced dental technician. The indirect composite material was photo- and heat-polymerized and both indirect materials were hand polished. Increased degradation of the material itself was more prone with the indirect composite material as is seen in other laboratory and clinical studies [30–33]. Fractures, chippings and wear were frequently seen at the incisal palatal aspect. This could be related to function and antagonist teeth articulating over these margin-material surfaces. One internal fracture in a ceramic laminate veneer was observed in the second year of function. This fracture was not treated or removed, but evaluated and remained stable until the end of the study.
在定性評估中，最常觀察到的差異是複合樹脂修復材料的表面降解和失去光澤。直到最後一次追蹤前，所有陶瓷復形體都保持平滑和光澤度。兩種材料均在牙科技工所中進行處理，並由經驗豐富的牙醫技師按照製造商的說明進行製備。複合樹脂修復材料經過光聚合和熱聚合，兩種樹脂材料都經過手工拋光處理。正如在其他牙科技工所和臨床試驗中所見聞，複合樹脂修復材料較容易產生材料降解 [30–33]。切緣腭側經常出現斷裂、破損和磨損。這可能與這些邊緣材料表面咬合的功能和對牙有關。在使用的第二年觀察到陶瓷貼片內部發生斷裂，斷裂處沒有治療或移除，但評估後保持穩定，直到試驗結束。
Marginal quality was evaluated as adaptation of the veneer and discoloration of the margin. In different studies on ceramic laminate veneers as well as our study these were the mostly observed (adaptation: 56%; discoloration: 44%) qualitative complications [7,8,25,27,34,35] wear or degradation of the luting composite in the margins leads to discolorations but no caries was observed in any of the patients. Degradation of the margins was mostly observed in the palatal aspect and sometimes when the cervical outline was in dentin on the cervico-buccal aspect. Most of the marginal discolorations could be removed by polishing, however this was not performed as patients did not complain and further experimental evaluation could be performed.
邊緣品質主要評估貼片密合度和邊緣變色。在各種關於陶瓷貼片的試驗以及我們的試驗中，主要觀察到的（密合度：56%；變色：44%）有定性併發症 [7,8,25,27,34,35]、黏著複合樹脂材料的邊緣磨損或降解導致變色，但沒有在任何患者中觀察到齲齒。邊緣降解主要發生在腭側，有時在頰側齒頸部發生降解而露出牙本質。大多數邊緣變色可以透過拋光處理，但是由於患者沒有提出抱怨，因此沒有進行。可以後續再進行實驗性評估。
Evaluation of surrounding tissues did not show significant differences in gingival health between the two materials. Only one patient had 0.5 mm of recession at a central incisor (ceramic) and a lateral incisor (indirect composite), which was probably related to brushing method and not to material properties.
對周圍組織的評估中，並未顯示使用兩種材料的牙齦健康存在顯著差異。只有一名患者的正中門齒（陶瓷）和側門齒（複合樹脂修復）有 0.5 毫米的退化，這可能與刷牙方法有關，與材料特性無關。
When absolute failures are considered, the clinical performance of indirect resin composite and ceramic laminate veneers performed better up to 120 months. This finding is different from the first article which only had data up to 3 years with a mean observation time of 20.3 months. [3] Surface quality changes were more frequently observed in the composite veneer material that may require more maintenance over time.
當考慮絕對失敗時，複合樹脂修復材料和陶瓷貼片的臨床表現在長達 120 個月的時間內表現更好。這一項發現與第一篇文獻不同，後者僅有 3 年的數據資料，平均觀察時間為 20.3 個月。[3] 在複合樹脂貼片材料上更頻繁地觀察到表面品質變化，隨著時間推移可能需要更多的維護。
In conclusion, the ceramic veneers on maxillary anterior teeth in this study performed significantly better compared to the composite indirect laminate veneers after a decade, both in terms of survival rate and in terms of quality of the surviving restorations.
結論是，和複合樹脂修復貼片相比，本試驗中的上排前牙陶瓷貼片，其 10 年後存活率和存活復形體品質的表現明顯更好。
Fig. 4. a–b.
Patient after 1 and 5 years follow up A) Patient experienced a small chipping of tooth 11 after 1 year B) Patient after 5 years, note the difference in plaque adhesion and margin integrity between de composite and ceramic.
圖 4.a-b。
追蹤 1 年和 5 年後的患者 A) 患者在 1 年後經歷了 11 顆牙齒的細微破損 B) 患者在 5 年後注意到複合樹脂材料和陶瓷間的牙菌斑附著和邊緣完整性差異。
Fig. 5. a–b.
Patient after 5 years follow up A) Patient with saliva on the teeth where the difference between composite and ceramic is not clearly noticable B) Patient with dried teeth where the difference between composite and ceramic is clearly noticable.
圖 5.a-b。
追蹤 5 年後的患者 A)牙齒上有唾液的患者，複合樹脂材料和陶瓷之間的差異不明顯 B) 牙齒乾燥的患者，複合樹脂材料和陶瓷之間的差異明顯。
Gresnigt MMM, Cune MS, Jansen K, van der Made SAM, Özcan M. Randomized clinical trial on indirect resin composite and ceramic laminate veneers: Up to 10-year findings. J Dent. 2019 Jul;86:102–109. doi: 10.1016/j.jdent.2019.06.001. Epub 2019 Jun 7. PMID: 31181242.
