Gingival Recession, Gum Recession
Conditions
Keywords
Coronally Advanced Flap, V-CAF, Connective Tissue Graft, Tissue Regeneration, Miller Class III
Brief 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. 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.
Interventions
PROCEDUREVertically 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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Clinical measurements and digital analyses of intraoral scans will be performed by an independent examiner who will not participate in the surgical procedures.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
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 |
| Coronally Advanced Flap Difficulty Score (CAFDS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Recession Depth (RD) | Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12) | The distance from the cementoenamel junction (CEJ) to the free gingival margin (FGM) |
| Gingival Recession Width (RW) | Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12) | The horizontal distance between the two intersection points of the free gingival margin and the cementoenamel junction (CEJ) |
| Base of the Interdental Papilla (IPb) | Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12) | A linear segment connecting the most apical points of the CEJ of the two adjacent teeth, intersecting the interdental papilla |
| Interdental Papilla Height (IPh) | Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12) | The vertical distance from the base of the interdental papilla to the tip of the interdental papilla |
| Interdental Papilla Width (IPw) | Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12) | The length of a horizontal line parallel to the base of the interdental papilla, located 2 mm apical to the papillary tip |
| Keratinized Tissue Height (KT) | Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12) | The apicocoronal dimension of the keratinized gingival tissue |
| Gingival Thickness (GT) | Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12) | The horizontal distance from the gingival surface to the root/alveolar bone surface, measured at 2 mm apical to the free gingival margin |
| Vestibular Depth (RVD) | Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12) | The vertical distance from the free gingival margin to the depth of the vestibule |
| Root Coverage Esthetic Score (RES) | 3 months, 6 months, and 12 months post-operative (T3, T6, T12) | The professional esthetic evaluation score of the root coverage outcome |
| Area of Gingival Recession | Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12) | The total exposed root surface area |
Countries
Vietnam
Outcome results
None listed