| CTRI Number |
CTRI/2025/01/079020 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of collagen membrane on root coverage with or without insulin growth factor |
|
Scientific Title of Study
|
Evaluation of coronally advanced flap with Collagen Membrane (PERIOCOL)
with or without Insulin Growth Factor-1 (1GF-1) for the treatment of maxillary anterior gingival
recession defects: A Comparative Clinical Study |
| 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 Aman Narang |
| Designation |
PG Resident |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Room no. 2 Department of Periodontology Subharti dental college and hospital Swami Vivekananda Subharti University, NH58, Delhi Haridwar Bypass Road Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08860620767 |
| Fax |
|
| Email |
aman.narang01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mehvish Saleem |
| Designation |
Associate Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Room no. 2 Department of Periodontology Subharti dental college and hospital Swami Vivekananda Subharti University, NH58, Delhi Haridwar Bypass Road Meerut
Room no. 2 Department of Periodontology Subharti dental college and hospital Swami Vivekananda Subharti University, NH58, Delhi Haridwar Bypass Road Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8267011559 |
| Fax |
|
| Email |
mehvishkhan1087@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mehvish Saleem |
| Designation |
Associate Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Room no. 2 Department of Periodontology Subharti dental college and hospital Swami Vivekananda Subharti University, NH58, Delhi Haridwar Bypass Road Meerut
Room no. 2 Department of Periodontology Subharti dental college and hospital Swami Vivekananda Subharti University, NH58, Delhi Haridwar Bypass Road Meerut
UTTAR PRADESH
250005
India |
| Phone |
8267011559 |
| Fax |
|
| Email |
mehvishkhan1087@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aman Narang |
| Address |
Subharti Dental College and Hospital
Delhi Haridwar bypass road NH58 Meerut 250005 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Aman Narang |
Subharti Dental College and Hospital |
Room no. 2 Department of Periodontology Subharti dental college and hospital Swami Vivekananda Subharti University, NH58, Delhi Haridwar Bypass Road Meerut
Meerut
UTTAR PRADESH |
08860620767
aman.narang01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A
Coronally advanced flap with collagen membrane and Insulin like growth factor 1 |
10 patients with millers class I and class II defects treated with coronally advanced flap with collagen membrane and Insulin like growth factor 1.
follow up for 3 months will be done |
| Comparator Agent |
Group B Coronally advanced flap with collagen membrane |
10 patients with millers class I and class II defects treated with coronally advanced flap with collagen membrane.
Follow up for 3 months will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients should be free of systemic disease.
2. Miller’s Class I and II gingival recession defect at the buccal aspect of maxillary incisors or canines or premolars.
3. No previous periodontal surgery at the affected teeth.
4. Evidence of patient’s ability to perform good plaque control.
|
|
| ExclusionCriteria |
| Details |
1. Patient with history of any recent periodontal surgery in past 6 months.
2. Pregnant and lactating patients.
3. Smokers.
4. Recession defects associated with demineralization/caries, deep abrasion or restorations as well as teeth with evidence of pulpal pathology.
5. Un-cooperative patients.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recession length and width measured (in mm) measured by UNC-15 periodontal probe and vernier caliper at baseline 1 month and 3 months |
Recession length and width measured (in mm) measured by UNC-15 periodontal probe and vernier caliper at baseline 1month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level (in mm) measured by UNC-15 periodontal probe |
Baseline, 1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/02/2025 |
| 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="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
|
INTRODUCTION - Gingival recession is the apical migration of gingival edge to the
junction of cementum and enamel (CEJ). periodontal disease, accumulations,
inflammation, poor flossing, vigorous tooth brushing, erroneous occlusal
connections, and dominating roots are all potential causes of gingival
recession. due to the exposed dentin, gingival recession may produce increased
sensitivity.
OBJECTIVE –The
aim of the present study will be to comparatively evaluate the treatment of
Miller class I and Class II recession defects with Coronally advanced flap
along with GTR membrane and Insulin derived growth factor versus Coronally
advanced flap with GTR membrane alone
METHODOLOGY –Twenty
systemically healthy patients with a total of 20 gingival recession defects (Miller class I and class II) in teeth
showing clinical evidence of recession defect will be selected for the study. 10 patients will be subjected to coronally advanced flap with collagen membrane and Insulin like growth factor 1 whereas 10 patients will be subjected to coronally advanced flap with collagen membrane .
RESULTS – On 3 months a gain in clinical attachment level , increase in width of keratinized
gingiva and gain in root coverage will be observed. |