| CTRI Number |
CTRI/2023/05/052277 [Registered on: 03/05/2023] Trial Registered Prospectively |
| Last Modified On: |
11/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two treatment modalities using a minimally invasive surgical technique with blood concentrates vs intra-oral tissue graft for treating multiple gingival recessions. |
|
Scientific Title of Study
|
Comparison of Platelet Rich Fibrin versus Connective Tissue Graft in treatment of multiple adjacent gingival recessions using the Modified Microsurgical Tunnel Technique: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urbashi Roy Chowdhury |
| Designation |
Post graduate (MDS) |
| Affiliation |
Manipal College of Dental Sciences, Manipal academy of higher education, Mangalore |
| Address |
Room no.4, Department of periodontology, Manipal college of dental
sciences, Lighthouse hill road, hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7980584610 |
| Fax |
|
| Email |
urjoey810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa G Kamath |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal academy of higher education, Mangalore |
| Address |
Room no.4, Department of periodontology, Manipal college of dental
sciences, Lighthouse hill road, hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448454788 |
| Fax |
|
| Email |
deepa.gkamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa G Kamath |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal academy of higher education, Mangalore |
| Address |
Room no.4, Department of periodontology, Manipal college of dental
sciences, Lighthouse hill road, hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448454788 |
| Fax |
|
| Email |
deepa.gkamath@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room no 4, Department of periodontology, Manipal College of Dental Sciences, Manipal Academy of Higher Education, Light House Hill Road, Mangalore |
|
|
Primary Sponsor
|
| Name |
Manipal College Of Dental Sciences, Mangalore |
| Address |
Room no 4, Department of periodontology, Manipal College of Dental Sciences, Manipal
Academy of Higher Education, Light House Hill Road, Mangalore
|
| 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 |
| Urbashi Roy Chowdhury |
Manipal college of dental sciences,Mangalore |
Room no:4,Department of Periodontology, Lighthouse Hill Road
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
7980584610
urjoey810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Manipal College of Dental Sciences,Mangaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Root coverage using Connective tissue graft for millers class 1 multiple gingival recessions |
Root coverage Modified Microsurgical Tunnel Technique with Connective tissue graft for millers class 1 multiple adjacent gingival recessions for a period of 6 months |
| Intervention |
Root coverage using Platelet rich fibrin for millers class 1 multiple gingival recessions |
Root coverage using Modified Microsurgical Tunnel Technique with Platelet rich fibrin for millers class 1 multiple adjacent gingival recessions for a period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling Miller’s class I gingival recession involving any two teeth extending from central incisors to the premolars in either maxilla or mandible,
2.Full mouth Plaque score ≤30% and bleeding score ≤ 30 %
3.Gingival biotype ≥ 0.8mm
4.Cervical abrasion with or without restorations.
|
|
| ExclusionCriteria |
| Details |
1.Patients with compromised systemic diseases.
2.Pregnancy
3.History of root coverage
4.Need for antibiotic prophylaxis
5.Patients with habit of smoking.
6.Patients on blood thinners/anticoagulants
7.Patients with fixed orthodontic appliances.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recession depth (RD),Width of keratinized tissue (KT), Gingival Thickness(GT) |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level (CAL),Probing Depth (PD),Patient related outcome measures |
6 months |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/05/2023 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The randomised controlled study comprises of 2 groups diagnosed with mucogingival condition that is facial or buccal multiple adjacent miller’s class 1 gingival recessions, wherein one group is subjected to Modified microsurgical tunnel technique(MMTT) with Platelet Rich Fibrin and the other group is subjected to MMTT with Connective tissue graft. Both the treatment groups showed comparable positive primary and secondary outcomes. The subjects of test group were more satisfied in terms of patient related outcomes. |