| CTRI Number |
CTRI/2020/04/024868 [Registered on: 27/04/2020] Trial Registered Prospectively |
| Last Modified On: |
16/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of connective tissue graft versus advanced platelet rich fibrin in the management of gum recession |
|
Scientific Title of Study
|
coronally advanced flap with connective tissue graft or advanced platelet rich fibrin in the management of multiple gingival recession -A randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepa N |
| Designation |
post graduate |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
sri ramachandra institute of higher education and research
room no- 5
department of periodontology
porur-116
no. 5 nehru nagar,
first street
adayar-600020
Chennai
TAMIL NADU
600116
India |
| Phone |
7200784657 |
| Fax |
|
| Email |
deepanatarajan16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa N |
| Designation |
post graduate |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
sri ramachandra institute of higher education and research
department of periodontology
room no-5
porur-116
no. 5 nehru nagar,
first street
adayar-600020
Chennai
TAMIL NADU
600116
India |
| Phone |
7200784657 |
| Fax |
|
| Email |
deepanatarajan16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muthukumar |
| Designation |
Professor |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
sri ramachandra institute of higher education and research
department of periodontology
room no- 5
porur-116
Chennai
TAMIL NADU
600116
India |
| Phone |
7200784657 |
| Fax |
|
| Email |
dr.sm.perio@gmail.com |
|
|
Source of Monetary or Material Support
|
| N. Deepa
sri ramachandra institute of higher education and research
department of periodontology
room no- 5
porur-116
chennai |
|
|
Primary Sponsor
|
| Name |
N DEEPA |
| Address |
sri ramachandra institute of higher education and research
porur-116 |
| 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 |
| N Deepa |
sri ramachandra insititute of higher education and research |
department of periodontology
room no- 5
porur
chennai- 116
Chennai
TAMIL NADU |
7200784657
deepanatarajan16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
advanced platelet rich fibrin |
advanced platelet rich fibrin prepared using patients own blood and used in millers class 1 and 2 recession defects |
| Comparator Agent |
connective tissue graft |
connective tissue graft harvested from palate and used in millers class 1 and 2 recession |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 20-60 years
Presence of more than one Miller class I or II buccal gingival recession defects. (Miller 1985)
No Medication known to interfere with periodontal tissue health / healing (steroids, Ca channel blockers, antiepileptic agents, immunosuppresants)
• Absence of a history of previous periodontal surgery in the same site.
• Non-smoker or former smoker
|
|
| ExclusionCriteria |
| Details |
Current Smokers
Patients with any systemic disorder known to interfere with periodontal treatment such as diabetes, coronary heart disease, Rheumatoid Arthritis, Rheumatic Fever, SLE, Malignancy, Respiratory diseases, Renal diseases, Other (e.g., autoimmune diseases, fungal infections, immunological deficiencies, etc.)
• Presence of non carious cervical lesion.
• Pregnant / Lactating mothers
• Patients undergoing orthodontic treatment.
• Presence of Malocclusion
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mean root coverage, complete root coverage, |
baseline, 1,3 and 6 months follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| gingival thickness, width of keratinized gingiva and patient centered outcomes |
baseline, 1, 3 and 6 months follow-up |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
28/05/2020 |
| 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="1"
Days="1" |
|
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)?
|
|
Brief Summary
|
This is a prospective double blind parallel group randomized controlled trial done to compare the coronally advanced flap with connective tissue graft or advanced platelet rich fibrin in the management of multiple gingival recession. primary outcome variables will be to assess percentage of mean root coverage, complete root coverage using recesion esthetic score at 1,3 and 6 month follow-up. secondary outcome variable to assess gingival thickness at baseline, 1,3 and 6 month follow-up and assess patient centered outcomes visual analog scale and early wound healing index at 3 and 10 days |