| CTRI Number |
CTRI/2021/07/035240 [Registered on: 29/07/2021] Trial Registered Prospectively |
| Last Modified On: |
28/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Platelet concentrates using root coverage technique for the Treatment of Multiple Receded gums Defects in Humans |
|
Scientific Title of Study
|
Evaluation of effectiveness of Platelet Rich Fibrin Matrix (PRFM) membrane and Platelet Rich Fibrin (PRF) membrane using Vestibular Incision Subperiosteal Tunnel Access (VISTA) Approach Technique for the Treatment of Multiple Gingival Recession in Humans- A 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 |
DR Safiya Hassan |
| Designation |
post graduate |
| Affiliation |
datta meghe institute of medical sciences |
| Address |
department of periodontics sharad pawar dental college wardha sawangi (meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9964074803 |
| Fax |
|
| Email |
safiya.hassan50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Prasad Dhadse |
| Designation |
Professor and Head |
| Affiliation |
datta meghe institute of medical sciences |
| Address |
department of periodontics sharad pawar dental college wardha sawangi (meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822689401 |
| Fax |
|
| Email |
drprasaddhadse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Safiya Hassan |
| Designation |
post graduate |
| Affiliation |
datta meghe institute of medical sciences |
| Address |
department of periodontics sharad pawar dental college wardha sawangi (meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9964074803 |
| Fax |
|
| Email |
safiya.hassan50@gmail.com |
|
|
Source of Monetary or Material Support
|
| sharad pawar dental college |
|
|
Primary Sponsor
|
| Name |
sharad pawar dental college |
| Address |
sawangi meghe wardha maharashtra 442001 |
| 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 Safiya Hassan |
Sharad Pawar Dental College and Hospital |
Department of Periodontics
sharad pawar dental college wardha sawangi (meghe)
Wardha
MAHARASHTRA |
9964074803
safiya.hassan50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| intitutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
multiple gingival recession defects |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
(PRF) membrane using (VISTA) Approach technique |
Platelet Rich Fibrin (PRF) membrane using Vestibular Incision Subperiosteal Tunnel Access (VISTA) Approach technique will be evaluated at 1 week 3 and 6 months. |
| Intervention |
(PRFM) membrane using Vista |
Platelet Rich Fibrin Matrix (PRFM) membrane using (VISTA) Approach technique will be evaluated at 1 week 3 and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Presence of multiple gingival recession (more than one) defects on the labial/ buccal surfaces of the teeth either in maxilla or mandible classified as either Miller’s Class I or II.
2. Presence of ≥ 2 mm gingival recession depth
3. Radiographic evidence of sufficient interdental bone (the distance between the crestal bone and cementoenamel junction as ≤ 2mm).
4. Presence of adequate width of keratinized gingiva apical to recession.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Patients using tobacco products and smokers.
2. Un-cooperative patients.
3. Patients with unacceptable oral hygiene after phase I therapy and showing plaque score ≥1.
4. History of periodontal surgical treatment in quadrant selected for the study.
5. Pregnant lady or lactating mother.
6. Presence of badly caries teeth
7. Presence of mobile teeth.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| root coverage |
3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| gains in clinical attachment level, gingival thickness and improvement in the width of the keratinized gingiva |
3 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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/08/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study will be undertaken to evaluate the effectiveness of Platelet rich fibrin matrix (PRFM) membrane in Miller Class I and II multiple gingival recession defects with the following objectives: - To evaluate the effectiveness of Platelet rich fibrin matrix (PRFM) membrane using Vestibular Incision Subperiosteal Tunnel Access technique with respect to root coverage, gains in clinical attachment level, gingival thickness and improvement in the width of the keratinized gingiva.
- To evaluate the effectiveness of Platelet rich fibrin (PRF) membrane using Vestibular Incision Subperiosteal Tunnel Access technique in terms of root coverage, gain in clinical attachment level, gingival thickness and improvement in the width of keratinized gingiva.
- To compare the effectiveness of PRFM membrane with that of PRF membrane using Vestibular Incision Subperiosteal Tunnel Access technique in terms of root coverage and gain in clinical attachment level, gingival thickness as well as improvement in the width of keratinized gingiva.
- Inclusion Criteria:
1. Presence of multiple gingival recession (more than one) defects on the labial/ buccal surfaces of the teeth either in maxilla or mandible classified as either Miller’s Class I or II. 2. Presence of ≥ 2 mm gingival recession depth 3. Radiographic evidence of sufficient interdental bone (the distance between the crestal bone and cementoenamel junction as ≤ 2mm). 4. Presence of adequate width of keratinized gingiva apical to recession. Exclusion Criteria: 1. Patients using tobacco products and smokers. 2. Un-cooperative patients. 3. Patients with unacceptable oral hygiene after phase I therapy and showing plaque score ≥1. 4. History of periodontal surgical treatment in quadrant selected for the study. 5. Pregnant lady or lactating mother. 6. Presence of badly caries teeth 7. Presence of mobile teeth. |