FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045149 [Registered on: 01/09/2022] Trial Registered Prospectively
Last Modified On: 19/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of a gum graft and a dressing processed from animal skin for treatment of receded gums.  
Scientific Title of Study   Comparison of the outcomes of using connective tissue graft versus volume-stable collagen matrix with modified coronally advanced flap for the treatment of multiple adjacent gingival recessions: A randomized clinical trial with molecular analysis” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikender Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Division of Periodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India

South West
DELHI
110029
India 
Phone  8800798248  
Fax    
Email  vikenderyadav@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vikender Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Division of Periodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India

South West
DELHI
110029
India 
Phone  8800798248  
Fax    
Email  vikenderyadav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vikender Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Division of Periodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India

South West
DELHI
110029
India 
Phone  8800798248  
Fax    
Email  vikenderyadav@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikender Singh  All India Institute of Medical Sciences, New Delhi  Division of Periodontics, 5th floor, Centre for Dental Education and Research
South West
DELHI 
8800798248

vikenderyadav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Connective tissue graft  Connective tissue graft will be harvested from patient palate and sutured at the surgical site for root coverage and left in place, and covered with overlying modified coronally advanced flap. The graft will be placed once only at the time of surgery and will not be removed again being autogenous in nature. Duration of the study will be 6 months.  
Intervention  Volume stable collagen matrix  The volume stable collagen matrix device will be sutured at the surgical site for root coverage and left in place, and covered with overlying modified coronally advanced flap. The device will be placed once only at the time of surgery and will not be removed again being reservable in nature. Duration of the study will be 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a) systemically healthy individuals
b) Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy
c) Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of < 15%
d) No history of previous periodontal surgery at experimental sites
e) Presence of at least two adjacent Cairo RT1 (gingival recession with no loss of interproximal attachment) multiple buccal recessions ≥ 2 mm on anterior teeth or premolars in both jaws
f) Presence of an identifiable CEJ (a step ≤1 mm at CEJ level and/or presence of a root abrasion, but with an identifiable CEJ, will be accepted).
g) Probing depth (PD) ≤ 3 mm
h) Absence of non-vital, supraerupted or mobile teeth for treatment of gingival recession 
 
ExclusionCriteria 
Details  a) Molars and teeth with presence of restorations, caries or crowns in the area to be treated.
b) Gingival recessions presenting minimal amount (<1 mm) of keratinized tissue (KT) apical to recession area.
c) Pregnant and lactating females
d) Smokers or tobacco usage in any form
e) History of any systemic medication in last 3 months
f) Patients with coagulation disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare and evaluate effectiveness of connective tissue graft and volume-stable collagen matrix with modified coronally advanced flap procedure in terms of
gingival recession depth reduction and soft tissue thickness gain after either treatment.  
Baseline, 1 month, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Objective assessment of aesthetic outcome using root coverage esthetic score (RES)
To assess any differences in patient- centered outcome in terms of postsurgical pain till 1 week and dentinal hypersensitivity and aesthetic satisfaction.  
Baseline, 3 months, 6 months 
To assess revascularization and wound healing dynamics through expression of specific biomarkers in GCF   Baseline (prior to surgery), and at 7, 14, 28, 90 and 180 days after the treatment 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Gingival recession is a highly prevalent condition which results in exposure of root surface to the oral environment. It is usually associated with impaired aesthetics, hypersensitivity, tooth structure loss (root caries and non-carious cervical lesions) and difficulty in plaque control. Various surgical techniques have been proposed for the treatment of gingival recession. For most of the soft-tissue augmentation surgeries, adjunctive use of CTG is deemed as the gold standard treatment. However, its harvesting is often associated with increased patient morbidity and risk of postoperative complications. Researchers have been continually attempting to develop new biomaterials to overcome these limitations. A newly developed volume-stable collagen matrix (VCMX) has recently been introduced. However, at present it remains unknown to what extent VCMX may represent a valuable alternative to CTG in treatment of multiple GRs. Also, knowledge about influence of VCMX on early and late wound healing events in root coverage procedures is currently missing. Our study will determine the clinical efficacy of VCMX in treatment of multiple GRs and also assess the healing dynamics at molecular level through evaluation of angiogenic and wound healing biomarkers expressed in gingival crevicular fluid (GCF).  

 
Close