| CTRI Number |
CTRI/2021/03/031917 [Registered on: 11/03/2021] Trial Registered Prospectively |
| Last Modified On: |
10/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Mucograft and connective tissue graft in gingival recession cases. |
|
Scientific Title of Study
|
Comparative evaluation of collagen matrix and connective tissue graft along with coronally advanced flap in the treatment of gingival recession defects: A randomized control clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dulari Parekh |
| Designation |
Post graduate student |
| Affiliation |
Manubhai Patel Dental College |
| Address |
Department of Periodontology and Implantology
Manubhai Patel Dental College and hospital
Vishwajyoti ashram near Vishwamitri bridge
Muj-mahuda
Vadodara
Vadodara
GUJARAT
390011
India |
| Phone |
9712743477 |
| Fax |
|
| Email |
dulariparekh8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivlal Vishnoi |
| Designation |
Professor |
| Affiliation |
Manubhai Patel Dental College |
| Address |
Department of Periodontology and Implantology
Manubhai Patel Dental College and hospital
Vishwajyoti ashram near Vishwamitri bridge
Muj-mahuda
Vadodara
Vadodara
GUJARAT
390011
India |
| Phone |
9586869196 |
| Fax |
|
| Email |
vishnoishivlal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivlal Vishnoi |
| Designation |
Professor |
| Affiliation |
Manubhai Patel Dental College |
| Address |
Department of Periodontology and Implantology
Manubhai Patel Dental College and hospital
Vishwajyoti ashram near Vishwamitri bridge
Muj-mahuda
Vadodara
Vadodara
GUJARAT
390011
India |
| Phone |
9586869196 |
| Fax |
|
| Email |
vishnoishivlal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manubhai Patel dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Dulari Parekh |
| Address |
Department of Periodontology and Implantology
Manubhai Patel Dental College and hospital
Vishwajyoti Ashram near vishwamitri bridge
Muj-mahuda Vadodara |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dulari Parekh |
Manubhai Patel Dental College |
Department of Periodontology and Implantology Manubhai Patel
Dental College and hospital Vishwajyoti Ashram near vishwamitri
bridge Muj-mahuda Vadodara
Vadodara
GUJARAT |
9712743477
dulariparekh8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) FOR RESEARCH |
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 |
| Comparator Agent |
Muco gingival surgery |
collagen matrix with coronally advanced flap |
| Intervention |
Muco gingival surgery |
connective tissue graft with coronally advanced flap |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Miller s Class I or II gingival recessions at
least ≥ 2 mm located on incisors canines or
premolars
Age ≥18 years
Presence of tooth vitality
No periodontal surgical treatment in the
previous 24 months on the involved sites
Sufficient palatal donor tissue for the
indicated CTG
Patients with cervical decay fillings or
non carious cervical lesions are included after
removal of any filling material or decay from
the root surface and reconstruction of the lost
tooth structure |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases or conditions
coagulation defects psychiatric disorders
pregnancy
Patients with a history of smoking or current
smokers and tobacco chewers
Inability or unwillingness to complete the
study
Patients on steroid therapy
Patients with a history of drug allergy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the clinical efficacy
of collagen matrix to that of connective
tissue graft in combination with CAF in
the treatment of Miller s class I and II gingival
recession defects |
baseline
1 month
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare root coverage gain after using collagen matrix to that of connective
tissue graft in combination with CAF in
the treatment of Miller s class I and II gingival
recession defects |
baseline
1 month
3 months
6 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)
|
15/03/2021 |
| 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
|
Publication will arise from the results from the data and the results tabulated from this study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Evaluation and comparison of recession depth coverage by using collagen matrix or connective tissue graft along with coronally advanced flap in Miller s class I and II gingival recession defect cases from baseline to 6 months |