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Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix) (Pontic-Essix)

2026年7月31日 更新者：University of Bern

Socket Sealing With a Fixed Ovate Pontic Provisional Versus a Removable Provisional Following Tooth Extraction and Alveolar Ridge Preservation: A Randomized Controlled Trial

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 瑞士
    • Canton of Bern
      • Bern、Canton of Bern、瑞士、3010
        • University of Bern, Department of Reconstructive Dentistry and Gerodontology
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：Bio-Oss Collagen
Deproteinized bovine bone mineral with 10% collagen (Geistlich Pharma AG, Wolhusen, Switzerland). Used for alveolar ridge preservation by socket grafting after tooth extraction. CE-marked and used within the approved indication.
其他名称：
  • Fixed ovate pontic provisional
  • Removable Essix provisional with collagen matrix seal
程序：Fixed 3D-printed ovate pontic provisional restoration
Patient-specific 3D-printed provisional restoration (PMMA or comparable clinically approved dental provisional material) incorporating an ovate pontic design. Retained by adhesive bonding or temporary cementation on the adjacent teeth. The convex, highly polished pontic extends approximately 2 mm apical to the mucosal margin and above the level of the bone graft, providing active soft tissue support.
有源比较器：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.
设备：Bio-Oss Collagen
Deproteinized bovine bone mineral with 10% collagen (Geistlich Pharma AG, Wolhusen, Switzerland). Used for alveolar ridge preservation by socket grafting after tooth extraction. CE-marked and used within the approved indication.
其他名称：
  • Fixed ovate pontic provisional
  • Removable Essix provisional with collagen matrix seal
设备：Mucograft Seal
Patient-specific 3D-printed provisional restoration (PMMA or comparable clinically approved dental provisional material) incorporating an ovate pontic design. Retained by adhesive bonding or temporary cementation on the adjacent teeth. The convex, highly polished pontic extends approximately 2 mm apical to the mucosal margin and above the level of the bone graft, providing active soft tissue support.
程序：Removable Essix provisional restoration
Patient-specific removable thermoplastic Essix-type appliance with an integrated artificial tooth. The pontic is positioned above the mucosal level without intentional soft tissue contact. Delivered at the surgical visit after socket sealing with the collagen matrix.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Interproximal soft tissue height at 5 months
大体时间：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.
Baseline (T0) and 5 months after tooth extraction

次要结果测量

结果测量
措施说明
大体时间
Midfacial mucosal level at 5 months
大体时间：Baseline (T0) and 5 months
Vertical position of the midfacial mucosal margin at 5 months (mm), assessed on superimposed intraoral surface scans. The between-group difference is estimated using ANCOVA with the 5-month value as dependent variable and the baseline value as covariate.
Baseline (T0) and 5 months
Horizontal ridge contour at 5 months
大体时间：Baseline (T0) and 5 months
Horizontal ridge contour at 5 months (mm) at 1, 3, and 5 mm apical to the baseline mucosal reference, assessed on superimposed intraoral surface scans. Baseline-adjusted analysis at each level.
Baseline (T0) and 5 months
Mucosal thickness at 5 months
大体时间：Baseline (T0) and 5 months
Mucosal thickness at 5 months (mm) at 1, 3, and 5 mm apical to the baseline mucosal reference. Baseline-adjusted analysis at each level
Baseline (T0) and 5 months
Volumetric soft tissue at 5 months
大体时间：Baseline (T0) and 5 months
Volumetric soft tissue measurement at 5 months (mm3) within the defined region of interest, assessed on superimposed intraoral surface scans. Baseline-adjusted analysis.
Baseline (T0) and 5 months
Alveolar hard tissue volume at 5 months
大体时间：Baseline (T0) and 5 months
Volumetric measurement of alveolar hard tissue at 5 months (mm3), assessed on superimposed CBCT data. Baseline-adjusted analysis.
Baseline (T0) and 5 months
Alveolar hard tissue contour at 5 months
大体时间：Baseline (T0) and 5 months
Linear measurement of alveolar hard tissue contour at 5 months (mm), assessed on superimposed CBCT data. Baseline-adjusted analysis.
Baseline (T0) and 5 months
Postoperative discomfort (VAS)
大体时间：2 weeks and 4 weeks after tooth extraction
Postoperative discomfort assessed on a 100-mm visual analogue scale, ranging from 0 mm (no discomfort) to 100 mm (worst imaginable discomfort).
2 weeks and 4 weeks after tooth extraction
Patient satisfaction with function (VAS)
大体时间：5 months
Patient-rated satisfaction with the function of the provisional restoration, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
5 months
Patient satisfaction with esthetics (VAS)
大体时间：5 months
Patient-rated satisfaction with the esthetics of the provisional restoration, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
5 months
Patient satisfaction with comfort (VAS)
大体时间：5 months
Patient-rated satisfaction with the comfort of the provisional restoration, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
5 months
Overall treatment satisfaction (VAS)
大体时间：5 months
Patient-rated overall satisfaction with the treatment received, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
5 months
Willingness to undergo the same procedure again (VAS)
大体时间：5 months
Patient-rated willingness to undergo the same procedure again, assessed on a 100-mm visual analogue scale, ranging from 0 mm (definitely not) to 100 mm (definitely yes).
5 months
Oral Health Impact Profile (OHIP-G14)
大体时间：Baseline (T0) and 5 months
German version of the Oral Health Impact Profile, 14-item version. Summary score range 0 to 56; higher scores indicate worse oral health-related quality of life.
Baseline (T0) and 5 months
Geriatric Oral Health Assessment Index (GOHAI)
大体时间：Baseline (T0) and 5 months
German version of the Geriatric Oral Health Assessment Index. Summary score range 12 to 60; higher scores indicate better oral health-related quality of life.
Baseline (T0) and 5 months
Adverse events and provisional-related complications
大体时间：Up to 5 months
Occurrence and rate of adverse events, including postoperative infection, impaired wound healing, soft tissue dehiscence, loss or displacement of the bone substitute or collagen matrix, allergic or hypersensitivity reactions, pressure-induced mucosal lesions, debonding of the fixed provisional restoration, or irritation related to the Essix provisional.
Up to 5 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Bern

调查人员

  • 首席研究员：Nicole Schenk, Dr. med. dent.、University of Bern, Department of Reconstructive Dentistry and Gerodontology
  • 学习椅：Martin Schimmel, Prof. Dr. med. dent.、University of Bern, Department of Reconstructive Dentistry and Gerodontology
  • 研究主任：Emilio Couso-Queiruga, PD Dr. med. dent.、University of Bern, Department of Oral Surgery and Stomatology

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2029年2月1日

研究完成 (估计的)

2029年2月1日

研究注册日期

首次提交

2026年7月31日

首先提交符合 QC 标准的

2026年7月31日

首次发布 (实际的)

2026年8月6日

研究记录更新

最后更新发布 (实际的)

2026年8月6日

上次提交的符合 QC 标准的更新

2026年7月31日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Pontic-Essix
  • 2026-01626 (其他标识符：Swiss Ethics Committee (BASEC))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be publicly shared. The informed consent and data protection framework of this trial do not provide for unrestricted public sharing of coded participant-level data. Aggregated study results will be published in a peer-reviewed journal and posted in the Swiss National Clinical Trials Portal (SNCTP) and on ClinicalTrials.gov in accordance with ClinO Art. 65a.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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