| CTRI Number |
CTRI/2017/10/010148 [Registered on: 23/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/10/2017 |
| 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 Comparative Study to Evaluate the efficacy of periodontal plastic surgical procedure with and without application of Platelet Rich Fibrin Membrane in Treatment of Multiple Gingival Recession. This is a Clinical and Radiographic Trial. |
|
Scientific Title of Study
|
Comparative Evaluation of Coronally Advanced Flap with Orthodontic Button Application with and without Platelet Rich Fibrin Membrane in Treatment of Multiple Gingival Recession Defects: A Clinicoradiographic Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anushree Potey |
| Designation |
Post Graduate Student |
| Affiliation |
VSPM Dental College and Research Centre, Nagpur. |
| Address |
Dept. of Periodontics & Implantology
VSPM Dental College & Research Centre
Digdoh Hills, Hingna Road
Nagpur 440019
Maharashtra
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
07387995440 |
| Fax |
|
| Email |
p.anushree26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashri A Kolte |
| Designation |
Professor and Guide |
| Affiliation |
VSPM Dental College and Research Centre, Nagpur |
| Address |
Dept of Periodontics and Implantology VSPM Dental College and
Research Centre Digdoh Hills Hingna Road Nagpur
Nagpur
MAHARASHTRA
440019
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Professor and Head |
| Affiliation |
Vidya Shikshan Prasarak Mandals Dental College and Research Centre, Nagpur |
| Address |
Dept of Periodontics and Implantology Vidya Shikshan Prasarak Mandals Dental College and
Research Centre, Digdoh Hills Hingna Road, Nagpur.
Nagpur.
MAHARASHTRA.
440019
India
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 [] |
|
|
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 Anushree Potey |
VSPM Dental College and Research Centre, Nagpur. 440019 |
104, Department of Periodontics, VSPM Dental College &
Research Centre
Digdoh Hills Hingna
Road Nagpur 440019
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
07387995440
p.anushree26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having Multiple Gingival Recession Defects, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coronally advanced flap |
The trial is an Interventional study in the treatment of Multiple Gingival Recession Defects evaluating the effect of Coronally Advanced Flap Technique with Orthodontic Button Application in root coverage with and without placement of Platelet Rich Fibrin Membrane in the defects and also evaluating the dimensional changes in the gingiva obtained by CBCT. |
| Intervention |
Coronally advanced flap along with palcement of Platelet Rich Fibrin Membrane |
The trial is an Interventional study in the treatment of Multiple Gingival Recession Defects evaluating the effect of Coronally Advanced Flap Technique with Orthodontic Button Application in root coverage with and without placement of Platelet Rich Fibrin Membrane in the defects and also evaluating the dimensional changes in the gingiva obtained by CBCT. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients exhibiting bilateral Miller’s Class I and II multiple gingival recession defects.
2)Patients with ≥1mm of attached gingiva at gingival recession sites.
|
|
| ExclusionCriteria |
| Details |
1)Patients with history of any systemic disease or drug usage.
2)Patients 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 |
| Reduction in the recession depth and improvement in patient’s esthetics within 3 and 6 months. |
Reduction in the recession depth and improvement in patient’s esthetics within 3 and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the gingival dimension of gingiva (seen by CBCT) within 6 months |
Baseline and 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)
|
13/08/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
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 evaluating the effect of coronally advanced flap technique with orthodontic button application along with platelet rich fibrin membrane on root coverage and dimensional changes in gingiva in 20 patients exhibiting bilateral Miller’s Class I and II multiple gingival recession defects followed by re-evaluation at 3 and 6 months. The primary outcome measures will be reduction in the recession depth and improvement in patient’s esthetics. The secondary outcome will be increase in the dimensions of the gingiva which will be assessed by CBCT. |