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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:
Participants will:
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
Data Collection and Statistical Analysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Thickness (GT) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ngoc TM Nguyen, DDS | University of Medicine and Pharmacy at Ho Chi Minh City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City | Ho Chi Minh City | 70000 | Vietnam |
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.
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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.
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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.
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| Coronally Advanced Flap (CAF) alone | Procedure | 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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| Root Coverage Esthetic Score (RES) |
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 |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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