Advanced Platelet-Rich Fibrin and Coronally Advanced Flap for Gingival Recession Treatment
2026년 5월 28일 업데이트: Nguyen Thi Minh Ngoc, University of Medicine and Pharmacy at Ho Chi Minh City
Clinical Effectiveness of Advanced Platelet-Rich Fibrin Combined With Coronally Advanced Flap for Gingival Recession Treatment
The goal of this clinical trial is to learn if adding a natural healing material works better to treat receding gums in adults. Receding gums is a condition where the gum tissue pulls back and exposes the tooth root. The main questions it aims to answer are:
- Does the addition of this healing material help cover the exposed root better than the standard surgery?
- Does the material help the gum tissue heal faster and become thicker? Researchers will compare a standard gum surgery alone to the standard gum surgery combined with Advanced Platelet-Rich Fibrin (A-PRF). A-PRF is a healing material made directly from the participant's own blood during the surgery. This comparison will help see if A-PRF improves the final cosmetic look and gum health.
Participants will:
- Have their blood drawn at the start of the surgery to create the A-PRF material.
- Receive the gum surgery with or without the A-PRF material. Visit the clinic for checkups and gum measurements at 1 week, 2 weeks, 4 weeks, 1 month, 3 months, and 6 months after the surgery.
연구 개요
상태
모집하지 않고 적극적으로
정황
상세 설명
- Background and Rationale Gingival recession is a prevalent anatomical defect characterized by the apical shift of the gingival margin past the cementoenamel junction (CEJ). The Coronally Advanced Flap (CAF) is a reliable and widely applied technique for achieving esthetic root coverage. To overcome the limitations of autogenous grafts, Advanced Platelet-Rich Fibrin (A-PRF) has been introduced as a biologic adjunct. A-PRF is developed based on the Low-Speed Centrifugation Concept (LSCC), providing a porous 3D fibrin scaffold that continuously releases essential growth factors (such as PDGF, VEGF, and TGF-β) to accelerate soft tissue regeneration. This randomized, controlled, parallel-design clinical study aims to evaluate and compare the clinical efficacy of CAF combined with A-PRF versus CAF alone in treating localized gingival recession defects.
- Study Design and Sample Size The required sample size was calculated based on reference data from Padma et al. (2013) to achieve 80% power with a significance level of α = 0.05. Accounting for a 20% anticipated dropout rate, the final sample size was set to 11 defects per group, yielding a total of 22 gingival recession defects. Eligible participants must be 18 years or older, present with Cairo RT1 recession defects in the anterior or premolar region, and exhibit a keratinized tissue width ≥ 1 mm, keratinized tissue height ≥ 2 mm, and probing depth ≤ 2 mm. Defects are randomly allocated into the Test Group (CAF + A-PRF membrane) and the Control Group (CAF alone).
Clinical and Surgical Procedures
- A-PRF Preparation: At the initiation of the surgical procedure, 10 ml of venous blood is collected using a 24G butterfly needle into sterile glass tubes. Centrifugation is performed intra-operatively using a PRF Duo Quattro machine at 1500 rpm for 14 minutes following the LSCC protocol. The resulting A-PRF clot is carefully compressed in a PRF box to form a membrane with uniform thickness without damaging the cellular structure.
- Surgical Protocol: The surgical intervention follows the standardized CAF technique proposed by Martina Stefanini and Giovanni Zucchelli (2021). Following local anesthesia with Lidocaine 2% and mechanical root debridement, the root surface is chemically conditioned with EDTA 24% (PrefGel). In the Test Group, the intra-operatively prepared A-PRF membrane is stabilized over the defect using 6/0 resorbable sutures, whereas no graft is applied in the Control Group. The flap is then coronally advanced and secured tension-free with suspensory and interrupted sutures.
Data Collection and Statistical Analysis
- Clinical Assessments: Wound healing is evaluated using the Early Healing Index (EHI) at 1, 2, and 4 weeks post-surgery. Periodontal parameters-including Recession Depth (RD), Recession Width (RW), Clinical Attachment Level (CAL), Gingival Thickness (GT), and Height of Keratinized Tissue (HKT)-are measured at baseline, 1, 3, and 6 months by a calibrated, independent examiner using a UNC-15 probe and customized acrylic stents. The Mean Root Coverage (MRC), Complete Root Coverage (CRC), and Root Coverage Esthetic Score (RES) will also be calculated.
- Statistical Analysis: Data is processed using JASP version 0.96. The Shapiro-Wilk test is utilized to check for normal distribution. Intra-group variations over time are analyzed using the Friedman test followed by Conover post-hoc analysis with Bonferroni correction. Inter-group differences are assessed using the Mann-Whitney U test, with statistical significance strictly defined as p < 0.05.
연구 유형
중재적
등록 (실제)
11
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ho Chi Minh City, 베트남, 70000
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Patients aged 18 years or older.
- Presence of 1 to 2 gingival recession defects requiring treatment, classified as RT1 (Cairo 2011).
- Gingival recession defects located in the anterior or premolar regions of the maxilla or mandible.
- Gingival thickness ≥ 1 mm. Keratinized tissue width ≥ 2 mm. Probing depth ≤ 2 mm.
- Good oral hygiene, demonstrated by a mean Gingival Index (GI) ≤ 1 and a mean full-mouth Plaque Index (PI) ≤ 1.
Exclusion Criteria:
- Patients with systemic diseases affecting wound healing (e.g., diabetes mellitus, coagulation disorders).
- Pregnant or lactating women.
- Patients with a smoking habit.
- Teeth with interproximal bone loss.
- Severely malpositioned teeth.
- Presence of caries or cervical restorations at the experimental site.
- History of previous periodontal surgery at the selected sites.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Experimental: CAF + A-PRF
Patients in this group will receive the Coronally Advanced Flap (CAF) surgical technique combined with an Advanced Platelet-Rich Fibrin (A-PRF) membrane to treat the localized gingival recession defect.
The A-PRF membrane is prepared intra-operatively from the patient's own venous blood.
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The surgical procedure involves mechanical root debridement and chemical conditioning with 24% EDTA.
An Advanced Platelet-Rich Fibrin (A-PRF) membrane, prepared intra-operatively from the patient's venous blood using low-speed centrifugation (1500 rpm for 14 minutes), is adapted over the exposed root surface and secured with resorbable sutures.
A Coronally Advanced Flap (CAF) is then mobilized, advanced coronally to completely cover the A-PRF membrane and the cementoenamel junction (CEJ), and secured.
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활성 비교기: Active Comparator: CAF alone
Patients in this group will receive the Coronally Advanced Flap (CAF) surgical technique alone, without the addition of any grafting material or A-PRF membrane, to treat the localized gingival recession defect.
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The surgical procedure involves mechanical root debridement and chemical conditioning with 24% EDTA.
A Coronally Advanced Flap (CAF) is mobilized and advanced coronally to completely cover the exposed root surface and the cementoenamel junction (CEJ) without the use of any additional grafting material or A-PRF membrane.
The flap is then secured.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Root Coverage (MRC)
기간: Baseline, 1 month, 3 months, and 6 months post-surgery
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The percentage of root coverage calculated from the reduction in Recession Depth (RD).
RD is measured from the cementoenamel junction (CEJ) to the gingival margin using a standardized UNC-15 periodontal probe and customized acrylic stents to ensure reproducible angulation.
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Baseline, 1 month, 3 months, and 6 months post-surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gingival Thickness (GT)
기간: Baseline, 1 month, 3 months, and 6 months post-surgery
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The thickness of the soft tissue measured 1 mm apical to the gingival margin.
This is evaluated using an endodontic file with a rubber stop (guided by an acrylic stent) and measured with a digital caliper for high precision.
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Baseline, 1 month, 3 months, and 6 months post-surgery
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Root Coverage Esthetic Score (RES)
기간: 6 months post-surgery
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A professional esthetic evaluation of the treated area assessing five variables: gingival margin position, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color.
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6 months post-surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ngoc TM Nguyen, DDS, University of Medicine and Pharmacy at Ho Chi Minh City
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 8월 1일
기본 완료 (추정된)
2026년 6월 30일
연구 완료 (추정된)
2026년 6월 30일
연구 등록 날짜
최초 제출
2026년 5월 28일
QC 기준을 충족하는 최초 제출
2026년 5월 28일
처음 게시됨 (실제)
2026년 6월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 28일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 3151/ĐHYD-HĐĐĐ
개별 참가자 데이터(IPD) 계획
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예
IPD 계획 설명
The raw data will be available upon reasonable request to the corresponding author, provided that the request is aligned with the ethical approval and patient consent forms to ensure participant anonymity and data privacy.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
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