NCT07624591

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

May 28, 2026

Last Update Submit

May 28, 2026

Conditions

Gingival Recession

Keywords

Coronally Advanced Flap, Advanced Platelet-Rich Fibrin, Platelet-Rich Fibrin, Root Coverage, Periodontal Plastic Surgery

Outcome Measures

Primary Outcomes (1)

  • Mean Root Coverage (MRC)

    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

Secondary Outcomes (2)

  • Gingival Thickness (GT)

    Baseline, 1 month, 3 months, and 6 months post-surgery

  • Root Coverage Esthetic Score (RES)

    6 months post-surgery

Study Arms (2)

Experimental: CAF + A-PRF

EXPERIMENTAL

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.

Procedure: Coronally Advanced Flap (CAF) combined with Advanced Platelet-Rich Fibrin (A-PRF)

Active Comparator: CAF alone

ACTIVE COMPARATOR

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.

Procedure: Coronally Advanced Flap (CAF) alone

Interventions

Coronally Advanced Flap (CAF) combined with Advanced Platelet-Rich Fibrin (A-PRF)PROCEDURE

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.

Experimental: CAF + A-PRF
Coronally Advanced Flap (CAF) alonePROCEDURE

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.

Active Comparator: CAF alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Single Person

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Ngoc TM Nguyen, DDS

    University of Medicine and Pharmacy at Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the surgical nature of the intervention and the required venous blood collection for A-PRF preparation, the operating surgeon and the participants cannot be blinded. To minimize observer bias, an independent, calibrated examiner-who is completely unaware of the treatment group assignments-performs all periodontal measurements at baseline and during all follow-up visits.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A total of 22 localized gingival recession defects will be randomly assigned to one of two parallel arms: the Test Group (receiving the Coronally Advanced Flap combined with A-PRF) or the Control Group (receiving the Coronally Advanced Flap alone). Both groups will be treated and evaluated concurrently over a 6-month follow-up period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Dental Surgery

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 3, 2026

Study Start

August 1, 2025

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

VN(1)