Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession

Study Overview
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Brief Summary
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this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller Class I gingival recessions; and as a split-mouth study design one side will be treated with (SCTG+CAF), while the other will be treated with (XCM+CAF).

Detailed Description
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The aim of this study is to clinically compare between the subepithelial connective tissue graft (SCTG) plus coronally advanced flap (CAF) which is defined as the golden standard for the treatment of gingival recessions and Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) to treat class I Miller gingival recession. CAF elevation will be done as it described by (De Sanctis & Zucchelli 2007) with modifications in the the control group.The flap will be partially elevated in the (SCTG+CAF) group while it will be a split-full-split thickness flap in the (XCM+CAF) group, and finally the flap will stabilized coronally. Fifteen patients who have bilateral buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (XCM+CAF) and control group (SCTG+CAF). Clinical parameters will be evaluated: Recession depth (REC), change in visible plaque index, recession width (RW), width of keratinized tissue (KT), thickness of gingival tissue (GT), probing depth (PD), clinical attachment level (CAL), healing index (HI), questionnaires will be given to evaluate each of patient perceptions, pain index (PI), and changes in root sensitivity by using visual analog scale (VAS).

Official Title
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Clinical Comparison of Coronally-advanced Flap Plus Xenogeneic Collagen Matrix (Fibro-Gide®) and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recessions

Conditions
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Gingival Recession Localized Moderate

Intervention / Treatment
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* Procedure: (XCM)+(CAF)
* Procedure: (SCTG)+(CAF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health. No contraindications for periodontal surgery. Presence of one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I defects (Miller 1985). The cemento-enamel junction (CEJ) is visible in the defective teeth. All patients demonstrating good plaque control. No previous periodontal surgery in the targeted area. Exclusion Criteria: Smokers. pregnant or nursing patients. history of malignancy, radiotherapy, or chemotherapy. Patients taking medications that affect mucosal healing. Patients with allergy to collagen. Previous participation in a clinical trial. Type-1 diabetes patients. Patient who have diseases that affect connective tissue metabolism.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: split-mouth design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (XCM)+(CAF)<br>Surgical protocol for test treatment with CAF + XCM: After local anesthetizing the recipient site,CAF elevation will be done using (De Sanctis & Zucchelli 2007) design.Horizontal incisions will be done at the recession site,another two slightly divergent vertical incisions will be done at the end of previous incisions extending to the mucogingival junction.The resulting flap will be split thickness in the surgical papillae area,then will be full thickness exposing 3-4 mm of the bone apically of the dehiscence and after that it will be split thickness in the apical direction,all the muscle insertions will be eliminated,the root surface will be prepared by curettes and chemically treated with 24% EDTA gel.De-epithelialization of the interdental papillae will be done.The XCM will be trimmed and fix onto the root surface 1-2mm coronally of the CEJ using absorbable sutures,and the flap will be coronally advanced to fully cover the XCM and then sutured to the de-epithelialized papillae. | Procedure: (XCM)+(CAF)<br>* The description of this intervention has been already given before.<br>|
| Active Comparator: (SCTG)+(CAF)<br>The surgical protocol in the control group will be identical with test group protocol with these exceptions: The entire flap will be elevated as split thickness instead of split-full-split thickness flap. A SCTG harvested from the palate will be used to cover the exposed denuded root surface in lieu of placement of XCM in the test group. And absorbable sutures will be used to stabilize it 2 mm coronally from the CEJ. As in the test group the mucosal flap will coronally advanced to completely cover the SCTG then sutured to the de-epithelialized papillae. | Procedure: (SCTG)+(CAF)<br>* The description of this intervention has been already given before.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession depth (REC): (Change in the amount of root coverage) | from the free gingival margin to the cemento-enamel junction at the mid-buccal aspect. Using University of North Carolina periodontal probe UNC15 (Medesey®-Italy). | 1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in visible plaque index: | Score 0 - No plaque Score 1 - Separate flecks of plaque at the cervical margin of the tooth Score 2 - A thin continuous band of plaque at the cervical margin of the tooth Score 3 - A band of plaque wider then 1mm covering less than 1/3rd of the crown of the tooth Score 4 - Plaque covering at least 1/3rd but less than 2/3rd of the crown of the tooth Score 5 - Plaque covering 2/3rd or more of the crown of the tooth | 1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative | 
| Recession width (RW) | at the cemento-enamel junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy). | 1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative. | 
| Width of keratinized tissue (KT) | from the free gingival margin to the mucogingival junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy). | 1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative. | 
| Thickness of gingival tissue (GT) | with an injection needle and a silicon marker, at the mid-buccal aspect below the gingival margin. | 1) at baseline, and 2) 3 months postoperative. | 
| Probing depth (PD) | the distance between the gingival margin and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy). | 1) at baseline, 2) and 3 months postoperative. | 
| Clinical attachment level (CAL) | distance between the CEJ and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy). | 1) at baseline, 2) at 3 months postoperative. | 
| Healing index | score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence. score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration. score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration. | 1) at two weeks following surgery and (2) at one month following surgery. | 
| Pain index (PI) | Using Visual Analogue scale (VAS) (2001 Crichton), Patients will be asked to select among 100 scores (0 indicating no pain at all , 50 indicating average pain, and 100 indicating very painful). | 1) at 2 hours, 2) 24 hours, 3) 48 hours,4) 72 hours following surgery and 5) at 1-week after surgery. | 
| Patient Perceptions | Using 100 cm Visual Analogue Scale (VAS)Patients will be asked to select among 100 scores (0 indicating very bad, 50 indicating average, and 100 indicating excellent results). | at three months post-surgery. | 
| Change in root sensitivity | Using a 100 cm-visual analog scale (VAS), patients' root sensitivity will be recorded with zero indicating no pain or sensitivity, 50 indicating moderate pain or sensitivity and 100 indicating worst pain or sensitivity possible. | 1) at baseline, 2) and at 3 months postoperative. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xenogenic collagen matrix (XCM)., subepithelial connective tissue graft (SCGT)., coronally advanced flap (CAF)., Root coverage.