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
|
|
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
|
|
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). |