| CTRI Number |
CTRI/2026/03/106592 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of root coverage technique with and without collagen membrane in patients with exposed root surface. |
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Scientific Title of Study
|
COMPARATIVE EVALUATION OF CONVENTIONAL VISTA TECHNIQUE VERSUS VISTA TECHNIQUE WITH COLLAGEN MEMBRANE IN THE MANAGEMENT OF MULTIPLE GINGIVAL RECESSION DEFECT A RANDOMISED CLINICAL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VINU PRIYA P |
| Designation |
POST GRADUATE |
| Affiliation |
Tamilnadu government dental college and hospital |
| Address |
Department of Periodontics,
Tamilnadu government dental college and hospital,
TNPSC road,Park town,
Chennai TAMIL NADU 600003 India |
| Phone |
8681921695 |
| Fax |
|
| Email |
vinurajaram@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
JAISHREE TUKARAM KSHIRSAGAR |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Tamilnadu government dental college and hospital |
| Address |
Department of Periodontics,
Tamilnadu government dental college and hospital,
TNPSC road,Park town,
Chennai TAMIL NADU 600003 India |
| Phone |
94449 19606 |
| Fax |
|
| Email |
jaishreekt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
VINU PRIYA P |
| Designation |
POST GRADUATE |
| Affiliation |
Tamilnadu government dental college and hospital |
| Address |
Department of Periodontics,
Tamilnadu government dental college and hospital,
TNPSC road,Park town,
Chennai TAMIL NADU 600003 India |
| Phone |
8681921695 |
| Fax |
|
| Email |
vinurajaram@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VINU PRIYA P |
| Address |
32/25,jagadeesan kadu,mulluvadi south street,gugai,salem-636006 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VINU PRIYA |
Tamilnadu government dental college and hospital |
Room 402,Department of Periodontics,TNGDCH,No1,TNPSC road,Park town,chennai -600003 Chennai TAMIL NADU |
8681921695
vinurajaram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional VISTA technique |
In patients with gingival recession,recession coverage using conventional VISTA technique |
| Intervention |
VISTA technique with collagen membrane |
In patients with gingival recession,recession coverage done with VISTA technique with collagen membrane and followed up for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients within the age group of 18 to 45 of either gender
Patient with good general health without any history of systemic disease or under medication.
Patient having Class I and Class II recession defects Millers classification system Cairos RT1 in Maxilla
Patients who are non smokers
Patient having adequate zone of attached gingiva with minimal probing depth in the treatment zone
Periodontally healthy patients
Patient willing to undergo minor surgical procedure
Patients willing to follow recommended plaque control and follow up regimen
Patients who are willing for voluntary participation and have signed informed consent
|
|
| ExclusionCriteria |
| Details |
Patients showing poor oral hygiene maintenance after Phase-I therapy.
Patients with known acute and chronic local and systemic disease.
Root caries and cervical abrasion.
Previous surgical attempt to correct the gingival recession.
Aberrant frenal attachment.
Molar and premolar teeth with furcation involvement.
Patients using any form of tobacco.
Patients who are alcoholics.
Pregnant / Lactating women
Patients with any known allergies.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Mean root coverage,recession depth reduction |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CAL,RECESSION WIDTH,PI,GI,PPD,PERCENTAGE OF ROOT COVERAGE |
6 months |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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)
|
25/03/2026 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vinurajaram@gmail.com].
- For how long will this data be available start date provided 01-08-2025 and end date provided 28-02-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
This randomized controlled trial compares the effectiveness of the conventional VISTA (Vestibular Incision Subperiosteal Tunnel Access) technique with VISTA technique using a collagen membrane for treating multiple gingival recession defects.A total of 24 patients will be selected based on the inclusion and exclusion criteria from outpatient sections of Department of Periodontics,Tamilnadu Government Dental College and Hospital.The patients will be assigned to one of the following groups with 12 patients in each GROUP A-Conventional VISTA technique,GROUP B-VISTA with collagen membrane.The study evaluates clinical outcomes such as root coverage, gain in clinical attachment level, reduction in recession depth, and overall esthetic improvement. Participants with multiple gingival recessions were randomly assigned to either the conventional VISTA group or the VISTA plus collagen membrane group.The objective was to determine whether adding a collagen membrane enhances the regenerative potential and improves treatment outcomes compared to the conventional technique alone. The results help clarify whether the adjunctive use of a collagen membrane provides significant additional clinical benefits in managing multiple gingival recession defects.
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