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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Nicole Schenk, Dr. med. dent.
- 電話番号：+41 31 684 06 35
- メール：nicole.schenk@unibe.ch
研究連絡先のバックアップ
- 名前：Martin Schimmel, Prof. Dr. med. dent.
- 電話番号：+41 31 684 06 35
- メール：martin.schimmel@unibe.ch
研究場所
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Canton of Bern
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Bern、Canton of Bern、スイス、3010
- University of Bern, Department of Reconstructive Dentistry and Gerodontology
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コンタクト：
- Nicole Schenk, Dr. med. dent.
- 電話番号：+41 31 684 06 35
- メール：nicole.schenk@unibe.ch
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
他の名前：
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.
|
|
アクティブコンパレータ：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.
|
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.
他の名前：
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.
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Interproximal soft tissue height at 5 months
時間枠：Baseline (T0) and 5 months after tooth extraction
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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.
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Baseline (T0) and 5 months after tooth extraction
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Midfacial mucosal level at 5 months
時間枠：Baseline (T0) and 5 months
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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.
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Baseline (T0) and 5 months
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Horizontal ridge contour at 5 months
時間枠：Baseline (T0) and 5 months
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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.
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Baseline (T0) and 5 months
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Mucosal thickness at 5 months
時間枠：Baseline (T0) and 5 months
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Mucosal thickness at 5 months (mm) at 1, 3, and 5 mm apical to the baseline mucosal reference.
Baseline-adjusted analysis at each level
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Baseline (T0) and 5 months
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Volumetric soft tissue at 5 months
時間枠：Baseline (T0) and 5 months
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Volumetric soft tissue measurement at 5 months (mm3) within the defined region of interest, assessed on superimposed intraoral surface scans.
Baseline-adjusted analysis.
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Baseline (T0) and 5 months
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Alveolar hard tissue volume at 5 months
時間枠：Baseline (T0) and 5 months
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Volumetric measurement of alveolar hard tissue at 5 months (mm3), assessed on superimposed CBCT data.
Baseline-adjusted analysis.
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Baseline (T0) and 5 months
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Alveolar hard tissue contour at 5 months
時間枠：Baseline (T0) and 5 months
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Linear measurement of alveolar hard tissue contour at 5 months (mm), assessed on superimposed CBCT data.
Baseline-adjusted analysis.
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Baseline (T0) and 5 months
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Postoperative discomfort (VAS)
時間枠：2 weeks and 4 weeks after tooth extraction
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Postoperative discomfort assessed on a 100-mm visual analogue scale, ranging from 0 mm (no discomfort) to 100 mm (worst imaginable discomfort).
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2 weeks and 4 weeks after tooth extraction
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Patient satisfaction with function (VAS)
時間枠：5 months
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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).
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5 months
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Patient satisfaction with esthetics (VAS)
時間枠：5 months
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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).
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5 months
|
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Patient satisfaction with comfort (VAS)
時間枠：5 months
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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).
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5 months
|
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Overall treatment satisfaction (VAS)
時間枠：5 months
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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).
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5 months
|
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Willingness to undergo the same procedure again (VAS)
時間枠：5 months
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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).
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5 months
|
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Oral Health Impact Profile (OHIP-G14)
時間枠：Baseline (T0) and 5 months
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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.
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Baseline (T0) and 5 months
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Geriatric Oral Health Assessment Index (GOHAI)
時間枠：Baseline (T0) and 5 months
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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.
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Baseline (T0) and 5 months
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Adverse events and provisional-related complications
時間枠：Up to 5 months
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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.
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Up to 5 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Nicole Schenk, Dr. med. dent.、University of Bern, Department of Reconstructive Dentistry and Gerodontology
- スタディチェア：Martin Schimmel, Prof. Dr. med. dent.、University of Bern, Department of Reconstructive Dentistry and Gerodontology
- スタディディレクター：Emilio Couso-Queiruga, PD Dr. med. dent.、University of Bern, Department of Oral Surgery and Stomatology
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Avila-Ortiz G, Gubler M, Romero-Bustillos M, Nicholas CL, Zimmerman MB, Barwacz CA. Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial. J Dent Res. 2020 Apr;99(4):402-409. doi: 10.1177/0022034520905660. Epub 2020 Feb 12.
- Couso-Queiruga E, Garaicoa-Pazmino C, Fonseca M, Chappuis V, Gonzalez-Martin O, Avila-Ortiz G. Interproximal Soft Tissue Height Changes After Unassisted Socket Healing vs Alveolar Ridge Preservation Therapy. Int J Periodontics Restorative Dent. 2024;44(5):520-533. doi: 10.11607/prd.6809.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2029年2月1日
研究の完了 (推定)
2029年2月1日
試験登録日
最初に提出
2026年7月31日
QC基準を満たした最初の提出物
2026年7月31日
最初の投稿 (実際)
2026年8月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月6日
QC基準を満たした最後の更新が送信されました
2026年7月31日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- Pontic-Essix
- 2026-01626 (その他の識別子：Swiss Ethics Committee (BASEC))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。