Gingival RecessionNCT07788443
V-CAF Technique for Miller Class III Gingival Recession
A study testing Vertically coronally advanced flap (V-CAF) in people with Gingival Recession and Gum Recession, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
The purpose of this clinical trial is to evaluate the effectiveness of a modified surgical technique called the vertically coronally advanced flap (V-CAF) combined with a connective tissue graft and tissue regeneration for treating gingival recession. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession, Gum Recession
- What is being tested?
- Vertically coronally advanced flap (V-CAF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Feb 2025to 25 Dec 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
- Systemically healthy (no systemic diseases) and not pregnant
- Non-smokers
- Presence of at least one tooth presenting with Miller Class III gingival recession with a recession depth of ≥ 2 mm
- Medium or thin gingival biotype
Who cannot join
- History of periodontal treatment or mucogingival/periodontal surgery at the study site
- Presence of fixed prosthesis on the tooth with gingival recession
- Teeth with rotation or crowding
- Presence of occlusal trauma
- Active or progressive periodontitis
- Patients who fail to attend follow-up visits or demonstrate non-compliance with post-operative care instructions
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, 700000
About this study
Official title: Evaluating the V-CAF Technique in Miller Class III Gingival Recession and the Correlation Between Coronally Advanced Flap Difficulty Score and Root Coverage Outcomes
The purpose of this clinical trial is to evaluate the effectiveness of a modified surgical technique called the vertically coronally advanced flap (V-CAF) combined with a connective tissue graft and tissue regeneration for treating gingival recession. For more severe cases (Miller Class III), the study investigates the relationship between the pre-operative Coronally Advanced Flap Difficulty Score (CAFDS) and post-operative outcomes, such as the root coverage rate and interdental papilla height. Participants will undergo the assigned surgical treatment and will be followed up at 3, 6, and 12 months to assess healing and tissue stability.
Read the detailed description
Gingival recession is a condition that causes root exposure, which can lead to dentin hypersensitivity and aesthetic concerns.
Initially, the study describes the clinical characteristics and factors associated with gingival recession utilizing clinical examinations, 3D intraoral scans, and Cone Beam Computed Tomography (CBCT).
The interventional surgical phase is the single-arm clinical trial involving Twenty-five Miller Class III gingival recession sites. This phase evaluates the correlation between the pre-operative Coronally Advanced Flap Difficulty Score (CAFDS) and clinical outcomes, specifically evaluating the root coverage percentage and interdental papilla height using the V-CAF technique. Standardized clinical parameters, including Recession Depth (RD), Keratinized Tissue (KT) height, Gingival Thickness (GT), Vestibular Depth (RVD), and the Root Coverage Esthetic Score (RES) will be recorded. Data will be collected at baseline (T0), 3 months (T3), 6 months (T6), and 12 months (T12) post-surgery to conduct comparative analyses.
- Conditions
- Gingival Recession, Gum Recession
- Being tested
- Vertically coronally advanced flap (V-CAF)
- Keywords
- Coronally Advanced Flap, V-CAF, Connective Tissue Graft, Tissue Regeneration, Miller Class III
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertically coronally advanced flap (V-CAF)Procedure or surgery
A surgical procedure utilizing a vertically coronally advanced flap combined with an autogenous connective tissue graft and tissue regeneration materials to treat gingival recession.
| Study group | Role | What they receive |
|---|---|---|
| V-CAF Group | Experimental | Participants with Miller Class III gingival recession receiving the vertically coronally advanced flap (V-CAF) procedure Receives: Procedure: Vertically coronally advanced flap (V-CAF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Root Coverage (MRC)
The mean percentage of root surface coverage achieved following treatment, assessed by measuring the root coverage area on intraoral scan files using digital measurement software
Measured: Baseline, 3 months, and 6 months after surgery
Coronally Advanced Flap Difficulty Score (CAFDS)
The Coronally Advanced Flap Difficulty Score (CAFDS) will be used to assess the anatomical difficulty of treating gingival recession defects with a coronally advanced flap. The score consists of eight anatomical parameters: papilla anatomy, apical keratinized tissue width, lateral keratinized tissue width, apical frenum, lateral frenum, vestibular depth, mucosal invagination, and scar tissue. Each parameter is assessed and assigned a predefined score according to the CAFDS system, with higher scores indicating greater surgical difficulty.
Measured: Baseline (T0), before surgery
Secondary outcomes (10)
Gingival Recession Depth (RD)
The distance from the cementoenamel junction (CEJ) to the free gingival margin (FGM)
Measured: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Gingival Recession Width (RW)
The horizontal distance between the two intersection points of the free gingival margin and the cementoenamel junction (CEJ)
Measured: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Base of the Interdental Papilla (IPb)
A linear segment connecting the most apical points of the CEJ of the two adjacent teeth, intersecting the interdental papilla
Measured: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Interdental Papilla Height (IPh)
The vertical distance from the base of the interdental papilla to the tip of the interdental papilla
Measured: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Interdental Papilla Width (IPw)
The length of a horizontal line parallel to the base of the interdental papilla, located 2 mm apical to the papillary tip
Measured: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Keratinized Tissue Height (KT)
The apicocoronal dimension of the keratinized gingival tissue
Measured: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Gingival Thickness (GT)
The horizontal distance from the gingival surface to the root/alveolar bone surface, measured at 2 mm apical to the free gingival margin
Measured: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Vestibular Depth (RVD)
The vertical distance from the free gingival margin to the depth of the vestibule
Measured: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Root Coverage Esthetic Score (RES)
The professional esthetic evaluation score of the root coverage outcome
Measured: 3 months, 6 months, and 12 months post-operative (T3, T6, T12)
Area of Gingival Recession
The total exposed root surface area
Measured: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Feb 2025
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm clinical trial evaluating the clinical efficacy of the vertically coronally advanced flap (V-CAF) combined with a connective tissue graft and tissue regeneration in the treatment of Miller Class III gingival recession defects. The study also investigates the correlation between the pre-operative Coronally Advanced Flap Difficulty Score (CAFDS) and post-operative clinical outcomes
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Thu Thuy, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788443
- Sponsor's protocol ID
- 3039/ĐHYD-HĐĐĐ
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the V-CAF Technique in Miller Class III Gingival Recession and the Correlation Between Coronally Advanced Flap Difficulty Score and Root Coverage Outcomes
- ClinicalTrials.gov ID
- NCT07788443
- Acronym / sponsor ID
- 3039/ĐHYD-HĐĐĐ
- Conditions
- Gingival Recession, Gum Recession
- Keywords
- Coronally Advanced Flap, V-CAF, Connective Tissue Graft, Tissue Regeneration, Miller Class III
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 26 Aug 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 purpose of this clinical trial is to evaluate the effectiveness of a modified surgical technique called the vertically coronally advanced flap (V-CAF) combined with a connective tissue graft and tissue regeneration for treating gingival recession. For more severe cases (Miller Class III), the study investigates the relationship between the pre-operative Coronally Advanced Flap Difficulty Score (CAFDS) and post-operative outcomes, such as the root coverage rate and interdental papilla height. Participants will undergo the assigned surgical treatment and will be followed up at 3, 6, and 12 months to assess healing and tissue stability.
Detailed description
Gingival recession is a condition that causes root exposure, which can lead to dentin hypersensitivity and aesthetic concerns.
Initially, the study describes the clinical characteristics and factors associated with gingival recession utilizing clinical examinations, 3D intraoral scans, and Cone Beam Computed Tomography (CBCT).
The interventional surgical phase is the single-arm clinical trial involving Twenty-five Miller Class III gingival recession sites. This phase evaluates the correlation between the pre-operative Coronally Advanced Flap Difficulty Score (CAFDS) and clinical outcomes, specifically evaluating the root coverage percentage and interdental papilla height using the V-CAF technique. Standardized clinical parameters, including Recession Depth (RD), Keratinized Tissue (KT) height, Gingival Thickness (GT), Vestibular Depth (RVD), and the Root Coverage Esthetic Score (RES) will be recorded. Data will be collected at baseline (T0), 3 months (T3), 6 months (T6), and 12 months (T12) post-surgery to conduct comparative analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm clinical trial evaluating the clinical efficacy of the vertically coronally advanced flap (V-CAF) combined with a connective tissue graft and tissue regeneration in the treatment of Miller Class III gingival recession defects. The study also investigates the correlation between the pre-operative Coronally Advanced Flap Difficulty Score (CAFDS) and post-operative clinical outcomes
| Arm | Type | Receives |
|---|---|---|
| V-CAF Group | Experimental | Procedure: Vertically coronally advanced flap (V-CAF)Participants with Miller Class III gingival recession receiving the vertically coronally advanced flap (V-CAF) procedure |
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
- Systemically healthy (no systemic diseases) and not pregnant
- Non-smokers
- Presence of at least one tooth presenting with Miller Class III gingival recession with a recession depth of ≥ 2 mm
- Medium or thin gingival biotype
Key exclusion criteria (6 listed)
- History of periodontal treatment or mucogingival/periodontal surgery at the study site
- Presence of fixed prosthesis on the tooth with gingival recession
- Teeth with rotation or crowding
- Presence of occlusal trauma
- Active or progressive periodontitis
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 |
|---|---|---|
| Vertically coronally advanced flap (V-CAF)A surgical procedure utilizing a vertically coronally advanced flap combined with an autogenous connective tissue graft and tissue regeneration materials to treat gingival recession. | Procedure or surgery | V-CAF Group |
Primary outcome
Mean Root Coverage (MRC)
Time frame: Baseline, 3 months, and 6 months after surgery
The mean percentage of root surface coverage achieved following treatment, assessed by measuring the root coverage area on intraoral scan files using digital measurement software
Coronally Advanced Flap Difficulty Score (CAFDS)
Time frame: Baseline (T0), before surgery
The Coronally Advanced Flap Difficulty Score (CAFDS) will be used to assess the anatomical difficulty of treating gingival recession defects with a coronally advanced flap. The score consists of eight anatomical parameters: papilla anatomy, apical keratinized tissue width, lateral keratinized tissue width, apical frenum, lateral frenum, vestibular depth, mucosal invagination, and scar tissue. Each parameter is assessed and assigned a predefined score according to the CAFDS system, with higher scores indicating greater surgical difficulty.
10 secondary outcomes
Gingival Recession Depth (RD)
Time frame: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Gingival Recession Width (RW)
Time frame: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Base of the Interdental Papilla (IPb)
Time frame: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Interdental Papilla Height (IPh)
Time frame: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Interdental Papilla Width (IPw)
Time frame: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Keratinized Tissue Height (KT)
Time frame: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Gingival Thickness (GT)
Time frame: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Vestibular Depth (RVD)
Time frame: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
Root Coverage Esthetic Score (RES)
Time frame: 3 months, 6 months, and 12 months post-operative (T3, T6, T12)
Area of Gingival Recession
Time frame: Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)
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 26 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertically coronally advanced flap (V-CAF) in people with Gingival Recession and Gum 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 6 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 26 Aug 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, 3 months, and 6 months after surgery). The study lists 2 primary outcomes in all. 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 26 Aug 2026.