Comparative Evaluation of CTG With and Without rhPDGF- BB Using Modified Coronally Advanced Tunnel for Root Coverage

Study Overview
=================
Brief Summary
-----------------
The present study is a human, prospective, single centre, single blind, comparative controlled randomized clinical trial for the treatment of Miller's Class I, II or combination of class I and II mandibular recession and comparing the clinical outcomes prior to and 6 months after treatment. The trial is in accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Detailed Description
-----------------
24 recession defects were selected in patients who were systemically and periodontally healthy, satisfying the determined inclusion criteria. Patients with at least two or more teeth having Miller's class I , II or combination of class I and II mandibular recession defects were included in the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, surgical procedure involved, potential benefits and risks associated with the surgical procedure and a written informed consent was obtained from all patients. The patients were assigned into two treatment groups (test and control). The test group was treated with recombinant human Platelet Derived Growth Factor-BB and Modified Coronally Advanced Tunnel +Connective Tissue Graft whereas the control group was treated by Modified Coronally Advanced Tunnel +Connective Tissue Graft alone.

Official Title
-----------------
Comparative Evaluation of rhPDGF- BB With Modified Coronally Advanced Tunnel and CTG Versus Modified Coronally Advanced Tunnel With CTG Alone for Root Coverage in Multiple Mandibular Gingival Recession Defects- A RCT

Conditions
-----------------
Gingival Recession

Intervention / Treatment
-----------------
* Procedure: root coverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients fulfilling the following criteria were included in the study:- Two or more teeth with Miller's class I and II or combined class I and II recession defects in mandibular anteriors. Age group 21-58 years. Patients with healthy or treated periodontal conditions. Patients willing to participate in the study. Absence of uncontrolled medical conditions. Patients with full mouth plaque score </= 10%(O'Leary 1972) Patients with esthetic concerns. Patients with thick gingival biotype >0.8mm Exclusion Criteria: Pregnant or lactating females. Tobacco smoking. Uncontrolled medical conditions. Untreated periodontal conditions. Use of systemic antibiotics in the past 3 months. Patients treated with any medication known to cause gingival hyperplasia. Drug and alcohol abuse No occlusal interferences. Patient with a known hypersensitivity to rhPDGF-BB.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 58 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients were assigned into two treatment groups (test and control). The test group was treated with recombinant human Platelet Derived Growth Factor-BB and Modified Coronally Advanced Tunnel +Connective Tissue Graft whereas the control group was treated by Modified Coronally Advanced Tunnel +Connective Tissue Graft alone.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group - rhPDGF-BB+MCAT+CTG<br>Root coverage surgical procedure.The patients were assigned into two treatment groups (test and control). Intervention - The test group recession coverage is treated with modified coronally advanced tunnel with connective tissue graft with recombinant human platelet derived growth factor- BB | Procedure: root coverage<br>* recession coverage is treated with modified coronally advanced tunnel with connective tissue graft with recombinant human platelet derived growth factor- BB for Experimental: Test group and without recombinant human platelet derived growth factor- BB for Active Comparator: Control group<br>* Other names: root coverage with/without growth factor;|
| Active Comparator: Control group - MCAT+CTG<br>Root coverage surgical procedure.The patients were assigned into two treatment groups (test and control). Intervention - The control group recession coverage is treated with modified coronally advanced tunnel with connective tissue graft alone | Procedure: root coverage<br>* recession coverage is treated with modified coronally advanced tunnel with connective tissue graft with recombinant human platelet derived growth factor- BB for Experimental: Test group and without recombinant human platelet derived growth factor- BB for Active Comparator: Control group<br>* Other names: root coverage with/without growth factor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival recession depth (GRD) | measured as the distance from the Cemento Enamel Junction to the gingival margin | 6 months | 
| 2. Gingival Recession Width (GRW) | measured as the distance between the mesial gingival margin and distal gingival margin | 6 months | 
| Mean root coverage(MRC) | (Baseline recession depth - 6 month recession depth/Baseline recession depth)*100 | 6 months | 
| Complete root coverage(CRC) | root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction | 6 months | 
| coverage esthetic score(RCES) | The Aesthetic evaluation was performed according to the root coverage aesthetic score system (RES) Five Variables evaluated which are as follows: Level of Gingival margin (GM) Marginal Tissue Contour (MTC) Soft Tissue Texture (STT) Mucogingival Junction(MJ) alignment Gingival Colour (GC) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing pocket depth (PD) | measured as the distance from the gingival margin to the base of gingival sulcus | 6 months | 
| clinical attachment level (CAL) | measured as Gingival Recession Depth + Probing Depth | 6 months | 
| width of keratinized tissue (KTW) | measured as the distance from the mucogingival junction to the gingival margin , with the mucogingival junction location determined using a visual method (Schiller's Potassium Iodide Solution). | 6 months |