Socket Sealing With a Fixed Ovate Pontic Provisional Versus a Removable Provisional Following Tooth Extraction and Alveolar Ridge Preservation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Interproximal soft tissue height at 5 months
研究概览
简要总结
This randomized controlled trial compares two provisional socket-sealing concepts following single non-molar tooth extraction and alveolar ridge preservation: a fixed, tooth-supported, 3D-printed ovate pontic provisional restoration providing active soft tissue support (test) versus a removable Essix-type provisional restoration without intentional soft tissue contact combined with a porcine collagen matrix seal (control). Both groups receive alveolar ridge preservation using a deproteinized bovine bone mineral with 10% collagen. The primary endpoint is interproximal soft tissue height at 5 months, adjusted for baseline, assessed by digital superimposition of intraoral surface scans. Up to 40 participants will be enrolled at the University of Bern School of Dental Medicine.
详细描述
Following tooth extraction, dimensional changes of the alveolar ridge and loss of interproximal soft tissue height may compromise esthetic and prosthetic outcomes. Alveolar ridge preservation attenuates hard tissue resorption but provides limited active support for the overlying soft tissues during healing. An ovate pontic provisional restoration may provide active soft tissue support and thereby help preserve interproximal soft tissue height. To date, no randomized controlled trial has compared a fixed ovate pontic provisional restoration with a removable non-contact Essix provisional restoration in the context of alveolar ridge preservation.
This is a single-center, open-label, confirmatory, randomized controlled trial with two parallel groups and 1:1 allocation. An adaptive design with an internal pilot phase (n=20) and blinded sample size re-estimation based on the residual variance of the primary endpoint is applied, up to a predefined maximum of 40 participants.
All participants undergo minimally traumatic, flapless single non-molar tooth extraction and alveolar ridge preservation with Bio-Oss Collagen. Test group: socket sealing by a fixed, 3D-printed ovate pontic provisional restoration providing active soft tissue support. Control group: socket sealing with Mucograft Seal plus a removable Essix-type provisional restoration positioned without intentional soft tissue contact.
Follow-up visits are performed at 2 weeks, 4 weeks, and 5 months. At baseline (T0) and at 5 months, intraoral surface scans, clinical photographs, cone-beam computed tomography, and patient-reported outcomes are collected. The between-group treatment effect on the primary endpoint is estimated using ANCOVA with the 5-month value as dependent variable, treatment group as fixed factor, and the baseline value as covariate; jaw is included as an additional between-subject factor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The trial is open-label for participants and treating clinicians because the two provisional restorations are clinically distinguishable. The examiner performing the digital analysis of intraoral surface scans and CBCT data is independent of the clinical treatment and is blinded to group allocation; outcome data are coded before analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •ASA physical status I or II
- •Requiring a single non-molar tooth extraction (incisor, canine, or premolar) in the maxilla or mandible, with planned tooth replacement
- •Extraction site bounded by natural, periodontally stable adjacent teeth
- •Intact alveolar socket upon extraction, or no more than one bony wall (facial, palatal, or lingual) presenting a dehiscence extending less than 50% of the total bony wall height
- •Willingness and ability to comply with the follow-up protocol
- •Ability to give informed consent, as documented by signature
排除标准
- •Current smokers, or former smokers who quit less than 6 months before extraction
- •Uncontrolled diabetes mellitus (HbA1c > 7.0%)
- •Clinical attachment loss ≥ 2 mm at the extraction site
- •Active or recent chemotherapy, or history of head and neck radiotherapy
- •Current or previous bisphosphonate therapy within the past 10 years
- •Immunosuppressive medication
- •Active oral or systemic acute infection
- •Severe hematologic disorder, hepatic or renal failure, or any clinically relevant bleeding disorder or anticoagulant medication that cannot be safely managed for the planned surgical procedure
- •Pregnancy or lactation
- •Known allergy or hypersensitivity to any of the study materials, including bovine-derived bone substitute, porcine-derived collagen matrix, or collagen-containing biomaterials
- •Any other disease or medication that may compromise normal wound healing
- •Inability to follow the study procedures (e.g., insufficient language comprehension, cognitive impairment, psychological disorder, or dementia)
- •Known or suspected non-compliance
- •Participation in another clinical trial that may interfere with the present study
研究组 & 干预措施
Fixed ovate pontic provisional
Following minimally traumatic, flapless tooth extraction, the alveolar socket is grafted with Bio-Oss Collagen. Socket sealing is achieved by a fixed, 3D-printed provisional restoration incorporating an ovate pontic design that extends approximately 2 mm apical to the mucosal margin, providing active soft tissue support to maintain interproximal papilla height and facial soft tissue contour during healing. The provisional is retained by adhesive bonding or temporary cementation on the adjacent teeth. No additional collagen matrix or sutures are placed.
干预措施: Bio-Oss Collagen (Device)
Fixed ovate pontic provisional
Following minimally traumatic, flapless tooth extraction, the alveolar socket is grafted with Bio-Oss Collagen. Socket sealing is achieved by a fixed, 3D-printed provisional restoration incorporating an ovate pontic design that extends approximately 2 mm apical to the mucosal margin, providing active soft tissue support to maintain interproximal papilla height and facial soft tissue contour during healing. The provisional is retained by adhesive bonding or temporary cementation on the adjacent teeth. No additional collagen matrix or sutures are placed.
干预措施: Fixed 3D-printed ovate pontic provisional restoration (Procedure)
Removable Essix provisional with collagen matrix seal
Following minimally traumatic, flapless tooth extraction, the alveolar socket is grafted with Bio-Oss Collagen. The socket is sealed with a porcine-derived collagen matrix (Mucograft Seal) secured with four to six single interrupted sutures, without primary closure. A removable Essix-type provisional restoration with an integrated artificial tooth is delivered; the pontic is positioned above the mucosal level without intentional soft tissue contact.
干预措施: Bio-Oss Collagen (Device)
Removable Essix provisional with collagen matrix seal
Following minimally traumatic, flapless tooth extraction, the alveolar socket is grafted with Bio-Oss Collagen. The socket is sealed with a porcine-derived collagen matrix (Mucograft Seal) secured with four to six single interrupted sutures, without primary closure. A removable Essix-type provisional restoration with an integrated artificial tooth is delivered; the pontic is positioned above the mucosal level without intentional soft tissue contact.
干预措施: Mucograft Seal (Device)
Removable Essix provisional with collagen matrix seal
Following minimally traumatic, flapless tooth extraction, the alveolar socket is grafted with Bio-Oss Collagen. The socket is sealed with a porcine-derived collagen matrix (Mucograft Seal) secured with four to six single interrupted sutures, without primary closure. A removable Essix-type provisional restoration with an integrated artificial tooth is delivered; the pontic is positioned above the mucosal level without intentional soft tissue contact.
干预措施: Removable Essix provisional restoration (Procedure)
结局指标
主要结局
Interproximal soft tissue height at 5 months
时间窗: Baseline (T0) and 5 months after tooth extraction
Interproximal soft tissue height at 5 months, calculated per participant as the mean of the mesial and distal measurements and expressed in millimeters. Measurements are obtained by digital superimposition of baseline and 5-month intraoral surface scans (Geomagic Control X, 3D Systems) by an independent, calibrated examiner. The between-group treatment effect is estimated using ANCOVA with the 5-month value as the dependent variable, treatment group as a fixed factor, baseline value as a covariate, and jaw as an additional between-subject factor.
次要结局
- Midfacial mucosal level at 5 months(Baseline (T0) and 5 months)
- Horizontal ridge contour at 5 months(Baseline (T0) and 5 months)
- Mucosal thickness at 5 months(Baseline (T0) and 5 months)
- Volumetric soft tissue at 5 months(Baseline (T0) and 5 months)
- Alveolar hard tissue volume at 5 months(Baseline (T0) and 5 months)
- Alveolar hard tissue contour at 5 months(Baseline (T0) and 5 months)
- Postoperative discomfort (VAS)(2 weeks and 4 weeks after tooth extraction)
- Patient satisfaction with function (VAS)(5 months)
- Patient satisfaction with esthetics (VAS)(5 months)
- Patient satisfaction with comfort (VAS)(5 months)
- Overall treatment satisfaction (VAS)(5 months)
- Willingness to undergo the same procedure again (VAS)(5 months)
- Oral Health Impact Profile (OHIP-G14)(Baseline (T0) and 5 months)
- Geriatric Oral Health Assessment Index (GOHAI)(Baseline (T0) and 5 months)
- Adverse events and provisional-related complications(Up to 5 months)