Advanced Platelet-Rich Fibrin and Coronally Advanced Flap for Gingival Recession Treatment
28. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Detaljert beskrivelse
- 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
Intervensjonell
Registrering (Faktiske)
11
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Ho Chi Minh City, Vietnam, 70000
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Root Coverage (MRC)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Gingival Thickness (GT)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Ngoc TM Nguyen, DDS, University of Medicine and Pharmacy at Ho Chi Minh City
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2025
Primær fullføring (Antatt)
30. juni 2026
Studiet fullført (Antatt)
30. juni 2026
Datoer for studieregistrering
Først innsendt
28. mai 2026
Først innsendt som oppfylte QC-kriteriene
28. mai 2026
Først lagt ut (Faktiske)
3. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 3151/ĐHYD-HĐĐĐ
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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