| CTRI Number |
CTRI/2024/07/070618 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
3D collagen matrix effect using tunnelled coronally advanced flap in patients with gum recessions |
|
Scientific Title of Study
|
Clinical effectiveness of 3D collagen matrix using tunnelled coronally advanced flap in cases of type 1 (RT1) and type 2 (RT2) gingival recessions : A Randomised controlled 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 |
Dr Amit Rajabhau Pawar |
| Designation |
PG student |
| Affiliation |
Saveetha Dental College and Hospital, Chennai. |
| Address |
Saveetha Dental College and Hospital, Poonamallee highway road, near Arvind eye hospital, Chennai, Tamilnadu, India.
Chennai
TAMIL NADU
600077
India |
| Phone |
9860532742 |
| Fax |
|
| Email |
152205005.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Kaarthikeyan |
| Designation |
Professor, HOD |
| Affiliation |
Saveetha Dental College and Hospital, Chennai. |
| Address |
Saveetha Dental College and Hospital, clinic 25, department of periodontology and implantology, Poonamallee highway road, Chennai, Tamilnadu, India.
Chennai
TAMIL NADU
600077
India |
| Phone |
9841222027 |
| Fax |
|
| Email |
Kaarthikeyan@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Rajabhau Pawar |
| Designation |
PG student |
| Affiliation |
Saveetha Dental College and Hospital, Chennai. |
| Address |
Saveetha Dental College and Hospital, Poonamallee highway road, near Arvind eye hospital, Chennai, Tamilnadu, India.
Chennai
TAMIL NADU
600077
India |
| Phone |
9860532742 |
| Fax |
|
| Email |
152205005.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospital, Poonamallee high way, Vellappanchavadi, Chennai. 600056 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospital, Chennai. |
| Address |
Saveetha Dental College and Hospital, Poonamallee highway road, Chennai. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Amit Pawar |
Saveetha dental college and hospital, Chennai, India. |
Clinic 25, Department of Periodontology and Implantology,Saveetha dental college and hospital, Poonamallee highway, Chennai, India.
Chennai
TAMIL NADU |
9860532742
152205005.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental Colege - Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D collagen matrix ( Fibro-Gide) |
Placement of 3D collagen matrix ( Fibri-Gide) using tunnelled coronally advanced flap technique in RT1 and RT2 gingival recession defects has to be done |
| Comparator Agent |
Connective Tissue Graft |
Placement of Connective Tissue Graft using tunnelled coronally advanced flap technique in RT1 and RT2 gingival recession defects has to be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age of the patient should be between 18-60 years.
2) RT1 and RT2 type gingival recession defects in multiple adjacent teeth.
3) Gingival recession ≥1mm.
4) Probing depth ≤4mm.
|
|
| ExclusionCriteria |
| Details |
1) patients with systemic diseases.
2) presence of caries at selected sites.
3) severely mal-aligned teeth.
4) tooth with mobility.
5) pregnancy.
6) use of medication with potentially adverse effects on periodontal tissues. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean root coverage
2. Recession height
3. Recession width
4. Width of keratinized tissue |
1 month, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Probing depth
2. Clinical attachment loss/ gain
|
1 month, 6 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
26/07/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Clinical effectiveness of 3D collagen matrix using tunnelled coronally advanced flap in cases of type 1 (RT1) and type 2 (RT2) gingival recessions is to be evaluated. |