Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

Study Overview
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Brief Summary
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Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.

Detailed Description
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This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Official Title
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Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Connective tissue graft
* Procedure: Free gingival graft
* Procedure: Non surgical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically free patients (American Society of Anesthesiologists I; ASA I) Patients diagnosed with recession (RT1) Fair oral hygiene Patient accepting to provides an informed consent and the follow-up Exclusion Criteria: Carious teeth and teeth with periapical infection. Patients diagnosed with periodontitis Smokers Pregnant and lactating females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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
Interventional Model Description: Three parallel groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Connective tissue graft<br>Patients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique | Procedure: Connective tissue graft<br>* non-surgical periodontal treatment and connective tissue graft<br>|
| Active Comparator: Free gingival Graft<br>Patients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft | Procedure: Free gingival graft<br>* will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft<br>|
| Active Comparator: Non surgical procedure<br>Patients will receive non-surgical periodontal treatment only | Procedure: Non surgical<br>* non-surgical periodontal treatment only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival phenotype change | determination of the change in gingival thickness in mm using periodontal probe | at baseline 3,6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratinized tissue width | determination of Keratinized tissue width in mm using periodontal probe | at baseline 3,6 and 12 months | 
| Root coverage esthetic score (RES) | It is a scoring system to assess the level of gingival margin (GM),marginal tissue contour (MTC),Soft tissue texture, Mucogingival alignment (MGJ),Gingival color The score is 0,1 and 3 where 0 is the minimum and 3 is the maximum | at baseline 3,6 and 12 months |