Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession.

Study Overview
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Brief Summary
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The aim of this study will be to clinically assess the soft tissue augmentation achieved by the de-epithelialized free gingival graft with coronally advanced flap versus the subepithelial connective tissue graft with coronally advanced flap as root coverage procedures for management of patients with Miller class I and II gingival recession.

Detailed Description
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Evidence from the literature showed that coronally advanced flap was a predictable method for root coverage. The addition of a connective tissue graft was also found to improve the outcome of obtaining complete root coverage in Miller class I and II gingival recession. Many different connective tissue graft-harvesting techniques have been utilized. These techniques aimed at reducing patient morbidity by primary closure of the palatal flap to achieve primary intention wound healing. However, they had the limitation of requiring an adequate thickness of the palatal fibromucosa in order to prevent desquamation of the undermined flap and compromised vasculature. On the other hand, the free gingival graft surgical technique was also unaccepted esthetically due to the white scar and irregularities produced at the monolingual junction. Moreover, despite the fact that the free gingival graft had its limitation of being associated with greater post-operative pain, discomfort and bleeding due to healing by secondary intention in 2-4 weeks, nevertheless, this technique was much easier to perform and could be used even in cases of thin palatal fibromucosa. The evidence in literature comparing patient morbidity and root coverage outcomes between these two techniques is minimal. Studies by Griffin et al. (2006) and Wessel and Tatakis (2008) reported increased incidence of post-operative pain with free gingival grafts. However, a recently study by Zucchelli et al. (2010) compared post-operative morbidity and root coverage outcomes in patients treated with trap-door connective tissue graft and de-epithelialized free gingival graft found no statistically significant differences in pain killer consumption, post-operative discomfort and bleeding between the two groups. Still very few studies measured the effect of different connective tissue graft harvesting techniques on gingival thickness. And even in the study by Zucchelli et al. (2010), only speculative explanation was given regarding the increase of gingival thickness in case of a de-epithelialized free gingival graft than subepithelial connective tissue graft. Gingival thickness was proved to be an important factor for the etiology of gingival recession as thick gingival tissues are able to confine the inflammation within the region of the gingival sulcus and prevent its extension to destroy the outer gingival tissue leading to gingival recession. Therefore, this study will monitor the effect of different connective tissue harvesting techniques (De-epithelialized free gingival graft versus subepithelial connective tissue graft) on gingival thickness enhancement. It will also evaluate the de-epithelialized free gingival graft as a harvesting mechanism for connective tissue graft in terms of patient morbidity and root coverage outcomes.

Official Title
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Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Controlled Clinical Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Coronally advanced flap and subepithelial connective tissue graft
* Procedure: Coronally advanced flap and deepithelialized free gingival graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years or older. Periodontally and systemically healthy. Buccal recession defects classified as either Miller class I or II. Presence of identifiable Cementoenamel juction (Zucchelli et al., 2010). Clinical indication and/or patient request for recession coverage. O'Leary index less than 20% (O'Leary et al., 1972). Exclusion Criteria: Miller class III or IV recession defects. Pregnant females. Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009). Handicapped and mentally retarded patients. Patients undergoing radiotherapy. Teeth with cervical restorations, abrasion. Presence of systemic disease that would affect wound healing.

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
Interventional Model Description: Parallel groups, randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subepithelial connective tissue graft<br>Patients will receive a coronally advanced flap surgery with a subepithelial connective tissue graft for recession coverage. | Procedure: Coronally advanced flap and subepithelial connective tissue graft<br>* The connective tissue graft is obtained by a single line incision from the palate.<br>|
| Experimental: De-epithelialized free gingival graft<br>Patients will receive a coronally advanced flap surgery with a de-epithelialized free gingival graft for recession coverage. | Procedure: Coronally advanced flap and deepithelialized free gingival graft<br>* The connective tissue graft is obtained by deepithelialization of a free gingival graft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Thickness | Thickness of the gingival tissues 2 mm from the free gingival margin | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of root coverage | (Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100. | 6 months | 
| Root coverage esthetic score | A system proposed for evaluating esthetic outcomes of root coverage procedures. | 6 months | 
| Post-Operative Pain | Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively | Two weeks | 
| Post-operative stress | level of stress experienced by the patients of jeopardizing the palatal wound during the time of healing | Two weeks | 
| Post-operative bleeding | prolonged hemorrhaging during the post-surgical week reported by the patients measured by a questionnaire as a categorical yes or no question. | Two weeks | 
| Post-operative inability to chew | Will be described as the level of variation of the patient's eating habits due to the presence of the palatal wound. | Two weeks | 
| Post-Surgical Patient Satisfaction | A 3-item questionnaire is asked and the patients shall use a 7-point answer scale. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gingival recession, connective tissue graft, deepithelialized free gingival graft, free gingival graft