Advanced Platelet-Rich Fibrin and Coronally Advanced Flap for Gingival Recession Treatment
28 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Gedetailleerde beschrijving
- 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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
11
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Ho Chi Minh City, Vietnam, 70000
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
|
|
Actieve vergelijker: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean Root Coverage (MRC)
Tijdsspanne: Baseline, 1 month, 3 months, and 6 months post-surgery
|
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.
|
Baseline, 1 month, 3 months, and 6 months post-surgery
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Gingival Thickness (GT)
Tijdsspanne: Baseline, 1 month, 3 months, and 6 months post-surgery
|
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.
|
Baseline, 1 month, 3 months, and 6 months post-surgery
|
|
Root Coverage Esthetic Score (RES)
Tijdsspanne: 6 months post-surgery
|
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.
|
6 months post-surgery
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Ngoc TM Nguyen, DDS, University of Medicine and Pharmacy at Ho Chi Minh City
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 augustus 2025
Primaire voltooiing (Geschat)
30 juni 2026
Studie voltooiing (Geschat)
30 juni 2026
Studieregistratiedata
Eerst ingediend
28 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
28 mei 2026
Eerst geplaatst (Werkelijk)
3 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
28 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 3151/ĐHYD-HĐĐĐ
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .