Gingival Recession Defects
Conditions
Keywords
V-CAF, CAF, Recession, Root coverage, SCTG
Brief summary
The aim of this randomized clinical trial will be to assess the change in recession depth after using a vertically coronally advanced flap with sub-epithelial connective tissue graft compared to a coronally advanced flap with sub-epithelial connective tissue graft after 6 months.
Detailed description
To test new approaches for root coverage for the treatment of RT1 and RT2 gingival recession.
Interventions
PROCEDUREVertically Coronally Advanced flap combined with sub-epithelial connective tissue graft
Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects. The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage.
PROCEDURECoronally Advanced flap combined with sub-epithelial connective tissue graft
The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* • Age ≥ 18 years. * Systemically healthy. * Non-smokers. * Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%. * Presence of identifiable CEJ. * Absence of non-carious cervical lesions. * Mature permanent tooth in the aesthetic zone. * At least one recession defect type RT1 and/ or RT2 in the upper or lower jaw. * Thin gingival phenotype (GT \< 0.8 mm) via probe transparency method. * A minimum of (2 mm KTW).
Exclusion criteria
* Any systemic disease. * Pregnancy or lactation. * Cairo RT3 recession defects. * Teeth with active orthodontic treatment. * Previous periodontal surgery in the area. * Use of any drugs that might lead to gingival enlargement. * Smoking. * Caries, restoration, mobility, unstable endodontic condition, and malocclusion in teeth undergoing treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in recession depth (mm) | at Baseline and 6 months | Change in recession depth in millimeters will be measured using a UNC-15 periodontal probe as the distance from the cementoenamel junction towards the most apical extension of the gingival margin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Recession Width (mm) | at baseline and 6 months | Gingival recession width will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the mesial to the distal papillae along the cementoenamel junction. |
| Keratinized Tissue Width (mm) | at Baseline and 6 months | Keratinized tissue width will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin at the deepest recession point till the mucogingival junction (MGJ), which will be identified using the roll technique |
| Keratinized Tissue Height (mm) | at Baseline and 6 months | Keratinized tissue height will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin to the mucogingival junction. |
| Probing Depth (mm) | at Baseline and 6 months | Probing depth will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the gingival crevice to the marginal gingiva. |
| Gingival Thickness (mm) | at Baseline and 6 months | Gingival thickness will be measured in millimetres using endodontic spreader no. 15 with a silicon disk stopper will be performed apical to the gingival margin by 2 mm at the middle of the long axis of the tooth mesio-distally using a UNC-15 periodontal probe.The depth of penetration will be measured using a ruler with precision up to the nearest 0.5 mm. |
| Recession Reduction (mm) | at Baseline and 6 months | Recession reduction will be calculated by comparing the initial gingival recession depth and gingival depth after treatment using a UNC-15 periodontal probe. |
| Clinical Attachment Level (mm) | at Baseline and 6 months | Clinical attachment level will be identified using a UNC-15 periodontal probe as the distance from the cementoenamel junction to the bottom of the gingival sulcus. |
| Complete Root Coverage (%) | at 6 months | Complete root coverage will be assessed by calculating the percentage of cases exhibiting a gingival margin that was either level with or positioned coronally to the cementoenamel junction in each group. |
| Bleeding on Probing (+/-) | at Baseline and 6 months | Bleeding on probing (BOP) will be measured using an UNC-15 periodontal probe, gently probing the gingival crevice, beginning inter-proximally from the mesial aspect and moving towards the distal. A positive finding for BOP will be recorded when bleeding occurred within 10s. |
| Plaque Index (scores 0, 1, 2, 3) | at Baseline and 6 months | Plaque index will be determined by drying the teeth in each quadrant with a gentle air blast, where the visibility of dental plaque and supragingival calculus will be noted. Each four tooth surfaces (buccal, lingual, mesial and distal) will be scored from 0 to 3, then scores of the four areas will be added and divided by four to give the average plaque index for each tooth. Scores: 0 : No plaque 1 : A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye. 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. |
| Post-Operative Pain (VAS) Visual Analogue Scale Questionnaire | Surgical day and days 1, 3, 7, and 14 after surgery | Post-operative pain will be indirectly evaluated on the basis of the mean consumption (in mg) of analgesics (ibuprofen). A questionnaire will be given to each patient; it will be divided into two parts to be completed in different time periods: the first part, regarding the post-operative discomfort and bleeding will be completed 1 week after the surgery based on a visual analogue scale of 100 mm.Postoperative pain will be assessed using a 100-mm Visual Analogue Scale, ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with higher scores indicating greater pain. |
| Patient Esthetic Satisfaction (RES) Root Coverage Esthetic Score | at 6 months | Patient aesthetic satisfaction will be assessed using the root coverage esthetic score (RES) at the 6 months follow up visit. The following five parameters will be evaluated: gingival margin level (0 = failure of root coverage; 3 = partial root coverage; 6 = complete root coverage), marginal tissue contour (0 = irregular; 1 = proper), soft tissue texture (0 = presence of scar/keloid; 1 = absence of scar/ keloid), mucogingival junction (MGJ) (0 = MGJ not aligned; 1 = MGJ aligned), and gingival color (0 = color differs from adjacent teeth; 1 = normal color and integration). A total RES score will be calculated by adding these 5 components |
| Mean Percentage of Root Coverage (mRC) % | (subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100 | Mean percentage of root coverage (mRC) will be calculated after 6 months as the percentage reduction in gingival recession depth from baseline to 6 months post-treatment, using the following formula: mRC (%) = \[(RD₀ - RD6) / RD₀\] × 100, where RD₀ represents the gingival recession depth at baseline and RD6 represents the gingival recession depth at 6 months post-treatment. |
Countries
Egypt
Contacts
CONTACTMai Magdy Abu El Eneen, PHD candidate
PRINCIPAL_INVESTIGATORMai Magdy Abu El Eneen, PHD candidate
Cairo University
Outcome results
None listed