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Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft

2026年6月19日 更新者:Nayer Aboelsaad、Beirut Arab University

Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft: A Randomized Controlled Clinical Trial

This randomized controlled clinical trial aims to evaluate a minimally invasive technique for peri-implant soft tissue augmentation using microneedling combined with injectable platelet-rich fibrin (i-PRF) compared with the current gold-standard connective tissue graft (CTG). Patients with thin peri-implant soft tissue requiring implant second-stage surgery in the esthetic zone will be randomly assigned to receive either CTG harvested from the palate or a series of microneedling and i-PRF treatments. Clinical outcomes including mucosal thickness, keratinized tissue width, peri-implant health parameters, volumetric soft tissue changes, esthetic outcomes, and patient-reported measures of pain and satisfaction will be evaluated during follow-up. The study aims to determine whether microneedling with i-PRF can provide comparable soft tissue augmentation while reducing patient morbidity associated with connective tissue graft harvesting.

調査の概要

詳細な説明

Peri-implant soft tissue quality is a key determinant of implant health, long-term stability, and esthetic outcomes. Adequate peri-implant mucosal thickness and keratinized tissue width contribute to the maintenance of peri-implant health, while thin soft tissue phenotypes have been associated with increased risk of recession, discomfort during oral hygiene procedures, and peri-implant tissue complications. Connective tissue grafting (CTG) remains the gold standard for peri-implant soft tissue augmentation; however, it requires harvesting autogenous tissue from a secondary donor site, resulting in increased surgical morbidity, postoperative discomfort, and longer treatment time.

Recent regenerative approaches have focused on the use of injectable platelet-rich fibrin (i-PRF), an autologous blood-derived concentrate rich in platelets, leukocytes, fibrin, and growth factors that promote angiogenesis, collagen formation, and soft tissue healing. Microneedling is a minimally invasive technique that creates controlled micro-injuries within the soft tissues, stimulating collagen production and enhancing the penetration and biological effects of regenerative agents. Preliminary evidence suggests that combining microneedling with i-PRF may enhance peri-implant soft tissue thickness and quality while minimizing patient morbidity.

This study is designed as a prospective, parallel-arm randomized controlled clinical trial comparing microneedling combined with injectable platelet-rich fibrin (MN+i-PRF) with connective tissue grafting (CTG) for peri-implant soft tissue augmentation during implant second-stage surgery. Approximately 24 eligible participants presenting with thin peri-implant soft tissue phenotype in the esthetic zone will be randomly allocated in a 1:1 ratio to either the test or control group. Allocation concealment will be performed using computer-generated randomization and sealed opaque envelopes. Outcome assessors will be blinded to treatment allocation.

Participants in the control group will undergo peri-implant soft tissue augmentation using a subepithelial connective tissue graft harvested from the palate and stabilized at the buccal aspect of the implant site. Participants in the test group will receive microneedling using a sterile automated microneedling device followed by injection of autologous i-PRF into the peri-implant mucosa. The test intervention will be performed at implant uncovery and repeated at 2-week and 4-week follow-up visits to maximize regenerative effects.

The primary outcome measure will be the change in peri-implant mucosal thickness from baseline. Secondary outcome measures will include keratinized tissue width, peri-implant probing depth, bleeding on probing, volumetric soft tissue contour changes assessed through intraoral scanning, Pink Esthetic Score (PES), and patient-reported outcome measures including postoperative pain and treatment satisfaction. Clinical and patient-centered outcomes will be evaluated at predefined follow-up intervals extending up to 9 months after treatment.

The objective of this study is to determine whether microneedling combined with i-PRF can provide peri-implant soft tissue augmentation outcomes comparable to connective tissue grafting while reducing treatment invasiveness and patient morbidity. The findings may contribute to the development of minimally invasive regenerative approaches for peri-implant phenotype modification and esthetic enhancement.

研究の種類

介入

入学 (推定)

24

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

研究場所

      • Beirut、レバノン
        • Beirut Arab University
        • コンタクト:

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:

  • Systemically healthy adults (Between 18 and 65) with one or more dental implants requiring second-stage surgery in the esthetic zone (Anteriors and Premolars).
  • Thin soft tissue phenotype: mucosal thickness or KTW <2 mm buccally.
  • Stable osseointegrated implant, adequate restorative space, and healthy adjacent teeth.
  • Good oral hygiene (PI ≤10%), with peri-implant maintenance.
  • Signed consent + willingness for 1-year follow-up.

Exclusion Criteria:

  • Heavy smokers (≥10 cig/day); light smokers only if reduced.
  • Systemic/healing issues: uncontrolled diabetes, immunocompromise, bleeding disorders, anticoagulants, steroids.
  • Pregnancy or breastfeeding.
  • Active infection (periodontal or peri-implant).
  • No residual keratinized mucosa on buccal side.
  • Previous graft/augmentation at the site or recent surgery (<6 months).
  • Allergies to anesthetics/materials.
  • Non-compliance with instructions or follow-up.

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:Connective Tissue Graft
Participants will receive peri-implant soft tissue augmentation using a subepithelial connective tissue graft harvested from the palate during implant second-stage surgery. The graft will be placed at the buccal aspect of the implant site to increase peri-implant mucosal thickness and improve soft tissue phenotype stability.
Peri-implant soft tissue augmentation performed using a subepithelial connective tissue graft harvested from the palate during implant second-stage surgery. The graft is placed at the buccal aspect of the implant site to increase mucosal thickness and improve peri-implant soft tissue phenotype.
実験的:Microneedling + Injectable Platelet-Rich Fibrin (MN+i-PRF)
Participants will receive peri-implant soft tissue augmentation using microneedling with a sterile automated microneedling device followed by injection of autologous injectable platelet-rich fibrin (i-PRF). The procedure will be performed during implant second-stage surgery and repeated at 2 and 4 weeks postoperatively.
Peri-implant soft tissue augmentation performed using automated microneedling followed by injection of autologous injectable platelet-rich fibrin (i-PRF) during implant second-stage surgery. The intervention is repeated at 2 and 4 weeks postoperatively to enhance peri-implant soft tissue thickness and quality.

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
Mucosal Thickness
時間枠:Baseline to 8 Weeks
Change in buccal peri-implant mucosal thickness (mm) measured at the mid-facial aspect, 2 mm apical to the mucosal margin, using standardized transgingival probing through a custom stent. Measurements will be compared between baseline and follow-up examinations.
Baseline to 8 Weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Keratinized Tissue Width (KTW)
時間枠:Baseline to 8 Weeks
Change in keratinized tissue width (mm) measured at the mid-facial aspect from the mucosal margin to the mucogingival junction using a calibrated periodontal probe.
Baseline to 8 Weeks
Peri-implant Probing Depth (PD)
時間枠:Baseline to 8 Weeks
Peri-implant probing depth (mm) measured at four sites per implant (mesiobuccal, mid-buccal, distobuccal, and lingual/palatal) using a calibrated periodontal probe and standardized probing force.
Baseline to 8 Weeks
Bleeding on Probing (BOP)
時間枠:Baseline to 8 Weeks
Presence or absence of bleeding following gentle periodontal probing at four peri-implant sites. Bleeding on probing will be recorded as an indicator of peri-implant soft tissue health.
Baseline to 8 Weeks
Volumetric Soft Tissue Contour Change
時間枠:Baseline to 8 weeks
Volumetric changes in peri-implant soft tissues assessed using intraoral digital scans and three-dimensional superimposition of STL files obtained at baseline and follow-up visits.
Baseline to 8 weeks
Pink Esthetic Score (PES)
時間枠:6 Months
Esthetic evaluation of peri-implant soft tissues using the Pink Esthetic Score. Standardized clinical photographs will be assessed to evaluate papilla fill, soft tissue contour, level, color, and texture around the implant restoration.
6 Months
Postoperative Pain
時間枠:24 Hours and 72 Hours Postoperatively
Participant-reported postoperative pain measured using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
24 Hours and 72 Hours Postoperatively
Patient Satisfaction
時間枠:8 Weeks
Participant satisfaction regarding treatment comfort, esthetic outcome, and willingness to undergo the procedure again, measured using a 10-point Visual Analog Scale (VAS).
8 Weeks

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

  • スタディチェア:Nayer Aboelsaad, PHD、Beirut Arab University

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

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6月26日

一次修了 (推定)

2027年2月26日

研究の完了 (推定)

2027年3月26日

試験登録日

最初に提出

2026年6月19日

QC基準を満たした最初の提出物

2026年6月19日

最初の投稿 (実際)

2026年6月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月25日

QC基準を満たした最後の更新が送信されました

2026年6月19日

最終確認日

2025年10月1日

詳しくは

本研究に関する用語

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?

未定

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

米国で製造され、米国から輸出された製品。

いいえ

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