| CTRI Number |
CTRI/2016/01/006543 [Registered on: 19/01/2016] Trial Registered Retrospectively |
| Last Modified On: |
10/01/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of multiple gingival recession defects by two technique - Coronally advanced flap and Coronally advanced flap with orthodontic button application |
|
Scientific Title of Study
|
Comparative evaluation of Coronally advanced flap and Coronally advanced flap with orthodontic button application in treatment of multiple gingival recession defects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumedh S Khobragade |
| Designation |
Post Graduate Student |
| Affiliation |
V.S.P.M Dental College & Research Centre |
| Address |
Dept. of Periodontics & Implantology
V.S.P.M Dental College & Research Centre
Digdoh Hills, Hingna Road
Nagpur 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09405318207 |
| Fax |
|
| Email |
007sumedh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Prof. & Head |
| Affiliation |
V.S.P.M Dental College & Research Centre |
| Address |
Dept. of Periodontics & Implantology
V.S.P.M Dental College & Research Centre
Digdoh Hills, Hingna Road
Nagpur 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Prof. & Head |
| Affiliation |
V.S.P.M Dental College & Research Centre |
| Address |
Dept. of Periodontics & Implantology
V.S.P.M Dental College & Research Centre
Digdoh Hills, Hingna Road
Nagpur 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
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 |
| DrSumedh S Khobragade |
104, Department Of Periodontics and Implantology V.S.P.M Dental College & Research Centre |
Digdoh Hills, Hingna Road
Nagpur: 440019
Maharastra, India
Nagpur
MAHARASHTRA |
09405318207
007sumedh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM’S Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with multiple gingival recessions., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coronally advanced flap along with orthodontic button application |
The trial is an Interventional trial in the treatment of gingival recessions.modified coronally advanced flap along with orthodontic button application was performed in group II in treatment of multiple gingival recession defects.
|
| Intervention |
modified coronally advanced flap |
The trial is an Interventional trial in the treatment of gingival recessions. Modified coronally advanced flap surgery was performed in treatment of multiple gingival recession defects.
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
46.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients exhibiting bilateral Miller’s class I and II multiple gingival recession defects.
2. Patients with ≥ 1 mm of attached gingiva at gingival recession site.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history any systemic disease or drug uses.
2. Subjects who have undergone periodontal therapy in the past 6 months.
3. Recession defects associated with caries and teeth with evidence of pulpal pathology
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gain in root coverage within 6 months. |
6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in gingival recession depth and location of gingival margin with respect to cementoenamel junction and patients esthetic evaluation according to root coverage esthetic score system. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Randomized, parallel group, active controlled clinical trial comparing the efficacy of Coronally advanced flap with orthodontic button application and Coronally advanced flap alone in 20 patients exhibiting bilateral gingival recession defects (20 sites for each group) followed by re-evaluation at 2, 4 and 6 months. The primary outcome measures will be improvement in patient’s periodontal status (reduced probing pocket depth, gain in clinical attachment level, and bone fill at periodontal defects. The secondary outcomes are patients esthetic evaluation according to the root coverage esthetic score system. |