Gingival RecessionNCT07624591
Advanced Platelet-Rich Fibrin and Coronally Advanced Flap for Gingival Recession Treatment
A study testing Coronally Advanced Flap (CAF) combined with Advanced Platelet-Rich Fibrin (A-PRF) and Coronally Advanced Flap (CAF) alone in people with Gingival Recession, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Coronally Advanced Flap (CAF) combined with Advanced Platelet-Rich Fibrin (A-PRF) and Coronally Advanced Flap (CAF) alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 70000
About this study
Official title: 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.
Read more
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.
Read the detailed description
- 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.
- Conditions
- Gingival Recession
- Being tested
- Coronally Advanced Flap (CAF) combined with Advanced Platelet-Rich Fibrin (A-PRF), Coronally Advanced Flap (CAF) alone
- Keywords
- Coronally Advanced Flap, Advanced Platelet-Rich Fibrin, Platelet-Rich Fibrin, Root Coverage, Periodontal Plastic Surgery
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally Advanced Flap (CAF) combined with Advanced Platelet-Rich Fibrin (A-PRF)Procedure or surgery
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.
Coronally Advanced Flap (CAF) aloneProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Coronally Advanced Flap (CAF) alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, and 6 months post-surgery
Secondary outcomes (2)
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.
Measured: Baseline, 1 month, 3 months, and 6 months post-surgery
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.
Measured: 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Thi Minh Ngoc, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Ngoc TM Nguyen, DDS, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624591
- Sponsor's protocol ID
- 3151/ĐHYD-HĐĐĐ
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Advanced Platelet-Rich Fibrin Combined With Coronally Advanced Flap for Gingival Recession Treatment
- ClinicalTrials.gov ID
- NCT07624591
- Acronym / sponsor ID
- 3151/ĐHYD-HĐĐĐ
- Conditions
- Gingival Recession
- Keywords
- Coronally Advanced Flap, Advanced Platelet-Rich Fibrin, Platelet-Rich Fibrin, Root Coverage, Periodontal Plastic Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: CAF + A-PRF | Experimental | Procedure: Coronally Advanced Flap (CAF) combined with Advanced Platelet-Rich Fibrin (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. |
| Active Comparator: CAF alone | Active comparator | Procedure: Coronally Advanced Flap (CAF) alonePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronally Advanced Flap (CAF) combined with Advanced Platelet-Rich Fibrin (A-PRF)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. | Procedure or surgery | Experimental: CAF + A-PRF |
| Coronally Advanced Flap (CAF) aloneThe 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. | Procedure or surgery | Active Comparator: CAF alone |
Primary outcome
Mean Root Coverage (MRC)
Time frame: 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.
2 secondary outcomes
Gingival Thickness (GT)
Time frame: Baseline, 1 month, 3 months, and 6 months post-surgery
Root Coverage Esthetic Score (RES)
Time frame: 6 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ngoc TM Nguyen, DDS principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronally Advanced Flap (CAF) combined with Advanced Platelet-Rich Fibrin (A-PRF) and Coronally Advanced Flap (CAF) alone in people with Gingival Recession, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Root Coverage (MRC) (time frame: Baseline, 1 month, 3 months, and 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.