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Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation (FGGIF)

2026年8月15日 更新者：Octavi Camps-Font、University of Barcelona

Multicenter Randomized Clinical Trial Comparing Apical Flap Repositioning Versus Vestibular Mucosa Excision Associated With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation

The goal of this clinical trial is to learn which surgical technique works better to increase the amount of firm gum tissue (called keratinized mucosa) around dental implants in adults.

The main question it aims to answer is:

-Does repositioning the gum flap upward with stitches lead to a greater gain in firm gum tissue width at 6 months compared to simply removing the extra gum tissue, when both techniques are combined with a free gum graft?

Researchers will compare two techniques used during the second stage of implant surgery to see which one produces a greater gain in firm gum tissue around the implant.

Participants will:

  • Receive a free gum graft (a small piece of tissue taken from the roof of the mouth) placed around their dental implant during a routine surgical visit
  • Be randomly assigned to one of the two surgical techniques
  • Have digital scans of their mouth taken at 5 timepoints over 6 months
  • Complete a pain diary and answer questions about their experience during the first week after surgery
  • Attend follow-up visits at 6 weeks, 3 months, and 6 months after surgery

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

This superiority multicenter randomized clinical trial is coordinated by the Universitat de Barcelona (UB) and includes the Universidad Complutense de Madrid (UCM) as a collaborating center.

Participant selection Adults with osseointegrated implants in the posterior maxilla or mandible presenting keratinized mucosa width of 2 mm or less and/or vestibular depth less than 4 mm will be screened for eligibility. Participants must be in periodontal and peri-implant health and have a plaque index of 15% or less.

Randomization Eligible participants will be randomly assigned (1:1) to one of two treatment groups using an Interactive Web Response System (IWRS) provided by Sealed Envelope Ltd. Randomization will take place intraoperatively, once the partial-thickness mucosal flap has been prepared.

Interventions

Group 1 (Control): Free gingival graft with apical repositioning and suturing of the vestibular mucosal flap to the periosteum Group 2 (Experimental): Free gingival graft with excision of the vestibular mucous tissue

Outcome assessment Soft tissue changes will be assessed at 5 timepoints (T0, Tim, T6w, T3m, T6m) using intraoral scans (TRIOS 3®, 3Shape) analyzed with Geomagic Control X® software through three-dimensional digital superimposition. Clinical measurements will also be performed using a calibrated periodontal probe and a customized thermoplastic stent to standardize the measurement point across visits.

Participants will complete a pain diary during the first 7 postoperative days recording pain intensity (100 mm visual analogue scale), analgesic consumption, and days with limited activity.

Sample size A total of 46 participants (23 per group) are required, accounting for a minimum clinically relevant difference of 1 mm in KTW gain, a standard deviation of 1.3 mm, 80% statistical power, 5% significance level, an intraclass correlation coefficient of 0.30 for multiple implants per patient, and a 15% dropout rate.

Statistical analysis The primary outcome will be analyzed in the intention-to-treat population using a generalized linear mixed model (GLMM), with patient as a random effect, adjusted for baseline KTW and study center.

研究の種類

介入

入学 (推定)

46

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：Octavi Camps-Font, DDS MS PhD
  • 電話番号：+34 934 024 269
  • メール：ocamps@ub.edu

研究連絡先のバックアップ

研究場所

  • スペイン
    • Barcelona
      • Barcelona、Barcelona、スペイン、08907
        • Hospital Odontològic Universitat de Barcelona, L'Hospitalet de Llobregat,
        • コンタクト：
          • Octavi Camps Font DDS MS PhD
          • 電話番号：+34 934 024 269
          • メール：ocamps@ub.edu

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:

  • Men or women aged 18 years or older who voluntarily agree to sign the informed consent form before any study-related procedure is performed.
  • Single or multiple edentulous spaces (≤3 units) located in the posterior maxilla or mandible, presenting osseointegrated implants in first-stage surgery with a -healing period of more than 8 weeks.
  • ASA classification I or II.
  • Periodontal and peri-implant health.
  • O'Leary plaque index ≤15%.
  • Keratinized mucosa width ≤2 mm and/or vestibular depth <4 mm at at least one site.
  • Commitment to attend all follow-up visits over 6 months.

Exclusion Criteria:

  • Systemic diseases that may interfere with performing FGG (free gingival graft), including but not limited to: poorly controlled diabetes mellitus (HbA1c > 8% or per clinical judgment), immunodeficiencies or immunosuppressive treatment, uncontrolled hematological diseases or coagulation disorders, anticoagulant or antiplatelet treatment that cannot be adjusted according to standard clinical practice, active neoplasms under treatment, severe renal or hepatic insufficiency, decompensated cardiovascular diseases, and any other medical condition that, in the investigator's judgment, could compromise participant safety or proper tissue healing.
  • Any contraindication to oral surgical procedures.
  • Periodontal and peri-implant health as defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
  • Patients who smoke tobacco or equivalent products, as well as former smokers with an abstinence period ≤12 months.
  • History of substance abuse (drugs or alcohol) or any other factor (e.g., severe psychiatric illness) that, in the investigator's opinion, could interfere with the patient's ability to cooperate and comply with the study.
  • Patients who have participated in a clinical trial within the last 30 days.
  • Pregnant or breastfeeding women.

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
アクティブコンパレータ：Apical Flap Repositioning
Free gingival graft with apical repositioning and suturing of the vestibular mucosal flap to the periosteum during second-stage implant surgery.
手順：Free gingival graft with apical flap repositioning
Autologous free gingival graft harvested from the palate and placed at the recipient site. The vestibular mucosal flap is repositioned apically and sutured to the periosteum during second-stage implant surgery.
実験的：Vestibular Mucosa Excision
Free gingival graft with excision of the vestibular mucous tissue during second-stage implant surgery.
手順：Free gingival graft with vestibular mucosa excision
Autologous free gingival graft harvested from the palate and placed at the recipient site. The vestibular mucous tissue is excised during second-stage implant surgery.

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
Peri-implant keratinized tissue width (KTW) gain
時間枠：Baseline (T0) to 6 months (T6m)
Absolute change in KTW, measured digitally as the linear distance between the mucosal margin and the mucogingival junction on the vestibular aspect of the implant, using Geomagic Control X® software on intraoral scan models (TRIOS 3®, 3Shape).
Baseline (T0) to 6 months (T6m)

二次結果の測定

結果測定
メジャーの説明
時間枠
Clinical gain in peri-implant keratinized tissue width (KTW)
時間枠：Baseline (T0) to 6 months (T6m)
Absolute change in KTW, measured clinically with a calibrated periodontal probe using a customized thermoplastic stent.
Baseline (T0) to 6 months (T6m)
Change in graft height
時間枠：Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Change in graft height, measured in millimeters (mm), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Change in graft width
時間枠：Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Change in graft width, measured in millimeters (mm), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Graft area contraction
時間枠：Immediate postoperative (Tim) to 6 months (T6m)
Percentage of graft area reduction between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Immediate postoperative (Tim) to 6 months (T6m)
Change in graft volume
時間枠：Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Change in graft volume, measured in cubic millimeters (mm³), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Vestibular depth
時間枠：Baseline (T0) to 6 months (T6m)
Change in vestibular depth from baseline to 6 months, assessed both digitally and clinically.
Baseline (T0) to 6 months (T6m)
Surgical time
時間枠：Intraoperative (Tim)
Time in minutes from anesthesia administration to placement of the last suture.
Intraoperative (Tim)
Adverse events
時間枠：Immediate postoperative (Tim) to 6 months (T6m)
Incidence and nature of postoperative adverse events related to the free gingival graft procedure.
Immediate postoperative (Tim) to 6 months (T6m)
Clinician-perceived surgical difficulty
時間枠：Intraoperative (Tim)
Degree of surgical difficulty perceived by the clinician at the end of the procedure, evaluated using a 100 mm visual analogue scale (0 = no difficulty, 100 = maximum imaginable difficulty).
Intraoperative (Tim)
Postoperative pain
時間枠：Up to 7 days postoperat
Pain intensity recorded at the end of the procedure and at 2, 6, 12 and 24 hours, and daily for 7 days, using a 100 mm visual analogue scale (0 = no pain, 100 = worst imaginable pain).
Up to 7 days postoperat
Analgesic consumption
時間枠：Up to 7 days postoperative
Number of doses of ibuprofen 600 mg and paracetamol 1 g consumed during the first 7 postoperative days.
Up to 7 days postoperative
Patient global satisfaction
時間枠：7 days postoperative
Overall satisfaction with the intervention evaluated at 7 days postoperative using a 100 mm visual analogue scale (0 = completely dissatisfied, 100 = completely satisfied).
7 days postoperative
Days with limitation of daily activity
時間枠：Up to 7 days postoperative
Number of days with total or partial limitation of usual daily activity during the first 7 postoperative days.
Up to 7 days postoperative

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

University of Barcelona

協力者

Universidad Complutense de Madrid

捜査官

  • スタディディレクター：Octavi Camps Font、University of Barcelona

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。

便利なリンク

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9月30日

一次修了 (推定)

2028年9月30日

研究の完了 (推定)

2029年3月30日

試験登録日

最初に提出

2026年8月3日

QC基準を満たした最初の提出物

2026年8月15日

最初の投稿 (実際)

2026年8月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月19日

QC基準を満たした最後の更新が送信されました

2026年8月15日

最終確認日

2026年8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

  • 26/2026

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

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

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