Gingival RecessionNCT07763093
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
A study testing Coronally Advanced Flap and Vertically Coronally Advanced Flap in people with Gingival Recession, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This randomized controlled clinical trial compares the clinical effectiveness of the Vertically Coronally Advanced Flap (VCAF) and the Coronally Advanced Flap (CAF), both combined with connective tissue graft (CTG) and enamel matrix derivative (EMD), for the treatment of Miller Class I gingival recession. 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 and Vertically Coronally Advanced Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 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
- Miller Class I gingival recession.
- Gingival recession depth ≥ 1 mm, assessed clinically with a periodontal probe.
- Medium or thin gingival thickness.
- No history of mucogingival or periodontal surgery at the study site.
Who cannot join
- Participants with uncontrolled systemic diseases, such as diabetes mellitus or hypertension, or coagulation disorders.
- Participants who do not attend follow-up visits or do not comply with the postoperative care instructions.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City
About this study
Official title: Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for the Treatment of Miller Class I Gingival Recession: A Randomized Controlled Trial
This randomized controlled clinical trial compares the clinical effectiveness of the Vertically Coronally Advanced Flap (VCAF) and the Coronally Advanced Flap (CAF), both combined with connective tissue graft (CTG) and enamel matrix derivative (EMD), for the treatment of Miller Class I gingival recession. Twenty-four Miller Class I gingival recession defects in 13 patients were randomly assigned in a 1:1 ratio to either the VCAF + CTG + EMD group or the CAF + CTG + EMD group; three patients contributed defects to both groups. Clinical outcomes, including mean root coverage, complete root coverage, recession depth, recession width, keratinized tissue width, gingival thickness, vestibular depth, and esthetic outcomes, are assessed at baseline and throughout a 6-month follow-up period. Three-dimensional digital models obtained from an intraoral scanner are used to evaluate soft tissue changes following treatment. The study is designed to determine whether the VCAF technique provides superior clinical and esthetic outcomes compared with the conventional CAF technique.
Read the detailed description
Gingival recession is a common mucogingival condition that may result in dentin hypersensitivity, root caries, plaque accumulation, and esthetic concerns. Coronally Advanced Flap (CAF) combined with connective tissue graft (CTG) is considered the gold standard for the treatment of localized gingival recession because of its predictable root coverage outcomes. However, coronal advancement of the flap may reduce vestibular depth, potentially affecting oral hygiene practices and long-term soft tissue stability.
The Vertically Coronally Advanced Flap (VCAF) technique has been developed to facilitate coronal flap advancement while preserving vestibular depth. This study compares VCAF and conventional CAF, both combined with CTG and enamel matrix derivative (EMD), to determine whether VCAF can provide comparable or improved root coverage while minimizing changes in vestibular depth and achieving favorable esthetic outcomes.
In addition to conventional clinical assessments, three-dimensional digital intraoral scans will be used to quantify soft tissue changes following surgery, providing a comprehensive evaluation of treatment outcomes.
Participants are additionally followed up to 12 months as part of a doctoral thesis; 12-month data are not among the registered outcomes.
- Conditions
- Gingival Recession
- Being tested
- Coronally Advanced Flap, Vertically Coronally Advanced Flap
- Keywords
- Vertically coronally advanced flap, Coronally advanced flap, Connective tissue graft, Enamel matrix derivative, Vestibular depth, Root coverage, Intraoral scanner
- 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 FlapProcedure or surgery
A root coverage surgical procedure using the conventional Coronally Advanced Flap (CAF) in combination with a connective tissue graft and enamel matrix derivative for the treatment of Miller Class I gingival recession.
Vertically Coronally Advanced FlapProcedure or surgery
A root coverage surgical procedure using the Vertically Coronally Advanced Flap (VCAF) in combination with a connective tissue graft and enamel matrix derivative for the treatment of Miller Class I gingival recession.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CAF + CTG + EMD) | Active comparator | Participants assigned to the control group will receive root coverage surgery using the conventional Coronally Advanced Flap (CAF) combined with a connective tissue graft (CTG) and enamel matrix derivative (EMD). Receives: Procedure: Coronally Advanced Flap |
| Experimental Group (VCAF + CTG + EMD) | Experimental | Participants assigned to the experimental group will receive root coverage surgery using the Vertically Coronally Advanced Flap (VCAF) combined with a connective tissue graft (CTG) and enamel matrix derivative (EMD). Receives: Procedure: Vertically Coronally Advanced Flap |
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
Vestibular Depth (VD)
The change in vestibular depth from baseline, measured on intraoral scan files using digital measurement software.
Measured: Baseline, 3 months, and 6 months after surgery
Secondary outcomes (6)
Complete Root Coverage (CRC)
The percentage of treated recession sites achieving complete coverage of the previously exposed root surface, assessed using intraoral scan files and digital measurement software.
Measured: Baseline, 3 months, and 6 months after surgery
Recession Depth (RD)
The vertical distance from the cementoenamel junction to the gingival margin, measured on intraoral scan files using digital measurement software.
Measured: Baseline, 3 months, and 6 months after surgery
Recession Width (RW)
The horizontal width of the gingival recession defect, measured on intraoral scan files using digital measurement software.
Measured: Baseline, 3 months, and 6 months after surgery
Keratinized Tissue Width (KTW)
The width of keratinized tissue at the treated site, measured on intraoral scan files using digital measurement software
Measured: Baseline, 3 months, and 6 months after surgery
Gingival Thickness (GT)
The thickness of the gingival tissue at the predefined measurement point, measured using intraoral scan files and digital measurement software.
Measured: Baseline, 3 months, and 6 months after surgery
Root coverage Esthetic Score (RES)
The esthetic outcome of root coverage treatment assessed using the Root Esthetic Score (RES). The score evaluates five esthetic parameters: gingival margin level, marginal tissue contour, soft tissue texture, mucogingival alignment, and gingival color.
Measured: 3 months, and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Feb 2025
- Primary completion4 Jun 2026
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel-group randomized controlled design. Eligible gingival recession defects will be randomly assigned in a 1:1 ratio to one of two intervention groups. The test group will receive treatment using the Vertically Coronally Advanced Flap (VCAF) combined with connective tissue graft (CTG) and enamel matrix derivative (EMD), while the control group will receive the conventional Coronally Advanced Flap (CAF) combined with CTG and EMD. Clinical and digital outcomes will be assessed at predefined follow-up visits to compare the effectiveness of the two surgical approaches. The unit of randomization is the gingival recession defect; a patient with more than one eligible defect could contribute defects to both groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 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
- Investigators
- Thuy T Nguyen, DDS, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763093
- Sponsor's protocol ID
- HCMUMP-VCAF-2026
- Other IDs
- 5671/QĐ-ĐHYD
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. Aggregated results will be reported in peer-reviewed publications; de-identified data may be shared upon reasonable request to the principal investigator, subject to institutional ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for the Treatment of Miller Class I Gingival Recession: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07763093
- Acronym / sponsor ID
- HCMUMP-VCAF-2026
- Conditions
- Gingival Recession
- Keywords
- Vertically coronally advanced flap, Coronally advanced flap, Connective tissue graft, Enamel matrix derivative, Vestibular depth, Root coverage, Intraoral scanner
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 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
- 4 Jun 2026 (actual)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 13 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.
This randomized controlled clinical trial compares the clinical effectiveness of the Vertically Coronally Advanced Flap (VCAF) and the Coronally Advanced Flap (CAF), both combined with connective tissue graft (CTG) and enamel matrix derivative (EMD), for the treatment of Miller Class I gingival recession. Twenty-four Miller Class I gingival recession defects in 13 patients were randomly assigned in a 1:1 ratio to either the VCAF + CTG + EMD group or the CAF + CTG + EMD group; three patients contributed defects to both groups. Clinical outcomes, including mean root coverage, complete root coverage, recession depth, recession width, keratinized tissue width, gingival thickness, vestibular depth, and esthetic outcomes, are assessed at baseline and throughout a 6-month follow-up period. Three-dimensional digital models obtained from an intraoral scanner are used to evaluate soft tissue changes following treatment. The study is designed to determine whether the VCAF technique provides superior clinical and esthetic outcomes compared with the conventional CAF technique.
Detailed description
Gingival recession is a common mucogingival condition that may result in dentin hypersensitivity, root caries, plaque accumulation, and esthetic concerns. Coronally Advanced Flap (CAF) combined with connective tissue graft (CTG) is considered the gold standard for the treatment of localized gingival recession because of its predictable root coverage outcomes. However, coronal advancement of the flap may reduce vestibular depth, potentially affecting oral hygiene practices and long-term soft tissue stability.
The Vertically Coronally Advanced Flap (VCAF) technique has been developed to facilitate coronal flap advancement while preserving vestibular depth. This study compares VCAF and conventional CAF, both combined with CTG and enamel matrix derivative (EMD), to determine whether VCAF can provide comparable or improved root coverage while minimizing changes in vestibular depth and achieving favorable esthetic outcomes.
In addition to conventional clinical assessments, three-dimensional digital intraoral scans will be used to quantify soft tissue changes following surgery, providing a comprehensive evaluation of treatment outcomes.
Participants are additionally followed up to 12 months as part of a doctoral thesis; 12-month data are not among the registered outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel-group randomized controlled design. Eligible gingival recession defects will be randomly assigned in a 1:1 ratio to one of two intervention groups. The test group will receive treatment using the Vertically Coronally Advanced Flap (VCAF) combined with connective tissue graft (CTG) and enamel matrix derivative (EMD), while the control group will receive the conventional Coronally Advanced Flap (CAF) combined with CTG and EMD. Clinical and digital outcomes will be assessed at predefined follow-up visits to compare the effectiveness of the two surgical approaches. The unit of randomization is the gingival recession defect; a patient with more than one eligible defect could contribute defects to both groups.
| Arm | Type | Receives |
|---|---|---|
| Control Group (CAF + CTG + EMD) | Active comparator | Procedure: Coronally Advanced FlapParticipants assigned to the control group will receive root coverage surgery using the conventional Coronally Advanced Flap (CAF) combined with a connective tissue graft (CTG) and enamel matrix derivative (EMD). |
| Experimental Group (VCAF + CTG + EMD) | Experimental | Procedure: Vertically Coronally Advanced FlapParticipants assigned to the experimental group will receive root coverage surgery using the Vertically Coronally Advanced Flap (VCAF) combined with a connective tissue graft (CTG) and enamel matrix derivative (EMD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Miller Class I gingival recession.
- Gingival recession depth ≥ 1 mm, assessed clinically with a periodontal probe.
- Medium or thin gingival thickness.
- No history of mucogingival or periodontal surgery at the study site.
Key exclusion criteria (2 listed)
- Participants with uncontrolled systemic diseases, such as diabetes mellitus or hypertension, or coagulation disorders.
- Participants who do not attend follow-up visits or do not comply with the postoperative care instructions.
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 FlapA root coverage surgical procedure using the conventional Coronally Advanced Flap (CAF) in combination with a connective tissue graft and enamel matrix derivative for the treatment of Miller Class I gingival recession. | Procedure or surgery | Control Group (CAF + CTG + EMD) |
| Vertically Coronally Advanced FlapA root coverage surgical procedure using the Vertically Coronally Advanced Flap (VCAF) in combination with a connective tissue graft and enamel matrix derivative for the treatment of Miller Class I gingival recession. | Procedure or surgery | Experimental Group (VCAF + CTG + EMD) |
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
Vestibular Depth (VD)
Time frame: Baseline, 3 months, and 6 months after surgery
The change in vestibular depth from baseline, measured on intraoral scan files using digital measurement software.
6 secondary outcomes
Complete Root Coverage (CRC)
Time frame: Baseline, 3 months, and 6 months after surgery
Recession Depth (RD)
Time frame: Baseline, 3 months, and 6 months after surgery
Recession Width (RW)
Time frame: Baseline, 3 months, and 6 months after surgery
Keratinized Tissue Width (KTW)
Time frame: Baseline, 3 months, and 6 months after surgery
Gingival Thickness (GT)
Time frame: Baseline, 3 months, and 6 months after surgery
Root coverage Esthetic Score (RES)
Time frame: 3 months, and 6 months after 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 14 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. Aggregated results will be reported in peer-reviewed publications; de-identified data may be shared upon reasonable request to the principal investigator, subject to institutional ethics approval.
Related trials for Gingival Recession
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Recruiting
Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
Gingival Recession
Active, not recruitingPhase 3
New In Situ Model Design for Caries and Erosion
Caries, Erosive Tooth Wear
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.
Thuy T Nguyen, DDS, PhD 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 and Vertically Coronally Advanced Flap 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 4 inclusion and 2 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 14 Oct 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 14 Oct 2026.