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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Connective Tissue Graft (CTG)
  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.
• Процедура Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF)
  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.

Первичные конечные точки

• Mucosal Thickness [Срок оценки: Baseline to 8 Weeks]

Вторичные конечные точки (7)

• Keratinized Tissue Width (KTW) [Срок оценки: Baseline to 8 Weeks]
• Peri-implant Probing Depth (PD) [Срок оценки: Baseline to 8 Weeks]
• Bleeding on Probing (BOP) [Срок оценки: Baseline to 8 Weeks]
• Volumetric Soft Tissue Contour Change [Срок оценки: Baseline to 8 weeks]
• Pink Esthetic Score (PES) [Срок оценки: 6 Months]
• Postoperative Pain [Срок оценки: 24 Hours and 72 Hours Postoperatively]
• Patient Satisfaction [Срок оценки: 8 Weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Ливан · 1 центр

• Beirut Arab University — Beirut

Публикации

• Ayyildiz BG, Eken S, Terzioglu B. The effect of the injectable platelet-rich fibrin on peri-implant soft tissue phenotype: a preliminary, prospective, 12-month follow-up clinical study. Clin Oral Investig. 2026 Mar 30;30(4):159. doi: 10.1007/s00784-026-06849-0. PMID 41910803
• Giammarinaro E, Baldini N, Covani U, Menini M, Pesce P, Marconcini S. Does platelet-rich fibrin enhance the outcomes of peri-implant soft tissues? A systematic review. BMC Oral Health. 2025 Apr 22;25(1):615. doi: 10.1186/s12903-025-05922-6. PMID 40264081
• Zurek J, Niemczyk W, Dominiak M, Niemczyk S, Wiench R, Skaba D. Gingival Augmentation Using Injectable Platelet-Rich Fibrin (i-PRF)-A Systematic Review of Randomized Controlled Trials. J Clin Med. 2024 Sep 20;13(18):5591. doi: 10.3390/jcm13185591. PMID 39337077
• Chetana, Sidharthan S, Dharmarajan G, Iyer S, Poulose M, Guruprasad M, Chordia D. Evaluation of microneedling with and without injectable-platelet rich fibrin for gingival augmentation in thin gingival phenotype-A randomized clinical trial. J Oral Biol Craniofac Res. 2024 Jan-Feb;14(1):49-54. doi: 10.1016/j.jobcr.2023.10.008. Epub 2023 Dec 15. PMID 38188907
• Valli Veluri S, Gottumukkala SN, Penmetsa GS, Ramesh K, P MK, Bypalli V, Vundavalli S, Gera D. Clinical and patient-reported outcomes of periodontal phenotype modification therapy using injectable platelet rich fibrin with microneedling and free gingival grafts: A prospective clinical trial. J Stomatol Oral Maxillofac Surg. 2024 Sep;125(4):101744. doi: 10.1016/j.jormas.2023.101744. Epub 2023 Dec 1 PMID 38128879

Идентификаторы

NCT: NCT07667855 · 2025-H-0185-D-M-0914

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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