Gingival Recession
Conditions
Keywords
Vertically coronally advanced flap, Coronally advanced flap, Connective tissue graft, Enamel matrix derivative, Vestibular depth, Root coverage, Intraoral scanner
Brief 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. 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.
Interventions
PROCEDURECoronally Advanced Flap
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.
PROCEDUREVertically Coronally Advanced Flap
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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical measurements and digital analyses of intraoral scans will be performed by an independent examiner who is blinded to treatment allocation. The examiner will not participate in the surgical procedures or the randomization process.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Root Coverage (MRC) | 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) | Baseline, 3 months, and 6 months after surgery | The change in vestibular depth from baseline, measured on intraoral scan files using digital measurement software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Root Coverage (CRC) | Baseline, 3 months, and 6 months after surgery | The percentage of treated recession sites achieving complete coverage of the previously exposed root surface, assessed using intraoral scan files and digital measurement software. |
| Recession Depth (RD) | Baseline, 3 months, and 6 months after surgery | The vertical distance from the cementoenamel junction to the gingival margin, measured on intraoral scan files using digital measurement software. |
| Recession Width (RW) | Baseline, 3 months, and 6 months after surgery | The horizontal width of the gingival recession defect, measured on intraoral scan files using digital measurement software. |
| Keratinized Tissue Width (KTW) | Baseline, 3 months, and 6 months after surgery | The width of keratinized tissue at the treated site, measured on intraoral scan files using digital measurement software |
| Gingival Thickness (GT) | Baseline, 3 months, and 6 months after surgery | The thickness of the gingival tissue at the predefined measurement point, measured using intraoral scan files and digital measurement software. |
| Root coverage Esthetic Score (RES) | 3 months, and 6 months after surgery | 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. |
Countries
Vietnam
Contacts
PRINCIPAL_INVESTIGATORThuy T Nguyen, DDS, PhD
University of Medicine and Pharmacy at Ho Chi Minh City
Outcome results
None listed