Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial

Study Overview
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Brief Summary
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To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.

Detailed Description
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To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts. To evaluate the esthetic outcome as perceived by periodontists, using the root coverage esthetic score (RES). Test Group - Tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts. Control Group - Tunnel technique and subepithelial palatal connective tissue grafts.

Official Title
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Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial

Conditions
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Cross-linked Hyaluronic Acid

Intervention / Treatment
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* Device: With Cross-linked Hyaluronic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: None of the patients were smokers and all were systemically healthy without any signs of periodontal disease. Each patient had to display at least one ginvigal recession (RT1) of a depth of ≥ 2 mm. Patients exhibited an adequate level of oral hygiene evidenced by a full- mouth plaque score (FMPS) < 25%39 and full-mouth bleeding score (FMBS) < 25%. Exclusion Criteria: Smokers Gingival recesstion RT 2 or RT 3 (Cairo 2011).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With Cross-linked Hyaluronic Acid<br>Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. | Device: With Cross-linked Hyaluronic Acid<br>* Without Cross-linked Hyaluronic Acid<br>|
| Placebo Comparator: Whitout Cross-linked Hyaluronic Acid<br>Tunnel Technique in Conjunction With Subepithelial Connective Tissue Graft. | Device: With Cross-linked Hyaluronic Acid<br>* Without Cross-linked Hyaluronic Acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival margin | Score 0: failure of root coverage (gingival margin apical or equal to the baseline recession); Score 3: partial root coverage; Score 6: complete root coverage with no detectable CEJ. | 6 month after surgery | 
| Marginal tissue contour | Score 0: irregular gingival margin (it does not follow CEJ); Score 1: proper marginal contour/scalloped gingival margin (following CEJ). | 6 month after surgery | 
| Soft tissue texture | Score 0: presence of scar formation and/or keloid-like appearance; Score 1: absence of scar or keloid formation. | 6 month after surgery | 
| Mucogingival junction | Score 0: MGJ not aligned with MGJ on adjacent teeth; Score 1: MGJ aligned with MGJ on adjacent teeth. | 6 month after surgery | 
| Gingival color | Score 0: color of tissue differs from gingival color on adjacent teeth; Score 1: normal color and integration with the adjacent soft tissues. | 6 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cross-linked hyaluronic acid, tunnel technique, gingival recession