CTRI Number |
CTRI/2022/04/042040 [Registered on: 21/04/2022] Trial Registered Prospectively |
Last Modified On: |
08/01/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Non-randomized, Multiple Arm Trial |
Public Title of Study
|
Management of gum recession using two types of membranes derived from blood |
Scientific Title of Study
|
Comparative evaluation of clinical efficacy of coronally advanced flap along with platelet rich fibrin obtained by two different centrifugation protocols in management of gingival recession -A prospective comparative 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 |
Kavitha Sridhar |
Designation |
Post graduate student |
Affiliation |
SRM Dental College |
Address |
Department of Periodontology, Post graduate clinic, 3rd floor, SRM dental, college, Ramapuram campus, Bharati salai, Chennai Department of Periodontology, Post graduate clinic, 3rd floor, SRM dental, college, Ramapuram campus, Bharati salai, Chennai Chennai TAMIL NADU 600089 India |
Phone |
7708468555 |
Fax |
|
Email |
kavithashobana123@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anupama Tadepalli |
Designation |
Professor |
Affiliation |
SRM Dental College |
Address |
Department of Periodontology, Post graduate clinic, 3rd floor, SRM dental, college, Ramapuram campus, Bharati salai, Chennai Department of Periodontology, Post graduate clinic, 3rd floor, SRM dental, college, Ramapuram campus, Bharati salai, Chennai Chennai TAMIL NADU 600089 India |
Phone |
9677065517 |
Fax |
|
Email |
anupamamds@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Kavitha Sridhar |
Designation |
Post graduate student |
Affiliation |
SRM Dental College |
Address |
Department of Periodontology, Post graduate clinic, 3rd floor, SRM dental, college, Ramapuram campus, Bharati salai, Chennai Department of Periodontology, Post graduate clinic, 3rd floor, SRM dental, college, Ramapuram campus, Bharati salai, Chennai Chennai TAMIL NADU 600089 India |
Phone |
7708468555 |
Fax |
|
Email |
kavithashobana123@gmail.com |
|
Source of Monetary or Material Support
|
SRM dental college and hospital |
|
Primary Sponsor
|
Name |
Kavitha Sridhar |
Address |
No .308, Casagrande Aristo, Nobel 1st street,
Alandur,
Chennai,
600016 |
Type of Sponsor |
Other [Self Funded] |
|
Details of Secondary Sponsor
|
Name |
Address |
Department of Periodontology |
3rd floor, Post graduate clinic, Department of Periodontology, SRM dental college, Bharathi salai, Ramapuram, Chennai 600089 |
NIL |
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Kavitha sridhar |
SRM dental college |
Department of periodontology and oral implantology, Post graduate clinic, Block 1, 3rd floor, SRM Dental college, Bharati salai, Ramapuram ,Chennai,
Tamil nadu. Chennai TAMIL NADU |
7708468555
kavithashobana123@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Board |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group 1: Coronally advanced flap and platelet rich fibrin obtained by horizontal spin protocol |
Sites with gingival recession are to be treated by coronally advanced flap and platelet rich fibrin obtained by horizontal spin protocol . |
Intervention |
Group 2: Coronally advanced flap and platelet rich fibrin obtained by angle spin protocol |
Sites with gingival recession are to be treated by coronally advanced flap and platelet rich fibrin obtained by angle spin protocol |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Systemically healthy subjects with an age range of 18-65 years.
2. Individuals diagnosed with recession defects in maxillary anteriors and premolars (Cairo’s RT1 & RT2 class of recession)
3. Sites with minimum depth of recession ≥2mm.
4. Isolated or multiple adjoining recession involving ≤3 teeth.
|
|
ExclusionCriteria |
Details |
1. Sites with probing pocket depth ≥4mm.
2. Teeth with mobility and/or associated with trauma from occlusion.
3. Sites with dental caries and prosthetic restorations.
4. Patients who exhibit unacceptable oral hygiene compliance during/or after phase Ι therapy.
5. Smokers.
7. Pregnant and lactating women.
8. Patients with known platelet disorders or using any medication that are known to interfere with platelet function.
9. Patients with systemic conditions or disease influencing the course of periodontal disease and therapy.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the following parameters between the study groups
1. Recession height
2. Root coverage percentage
|
Baseline
3 Months
6 Months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the following parameters between the study groups
1. Width of keratinized gingiva
2. Gingival thickness
|
Baseline
6 Months |
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="4" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/05/2022 |
Date of Study Completion (India) |
29/12/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not yet done |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Gingival recession is defined as the apical displacement of gingival margin to the cemento enamel junction (CEJ) exposing the root surface (Gustavo et al 2021 ). The causative factors include faulty tooth brushing, underlying periodontal disease, malaligned tooth, high frenal attachment causing marginal gingival pull, subsequently leading to the exposure of root causing esthetic concerns, hypersensitivity, plaque retention and caries to the patients. Platelet concentrates have been widely utilized in field of periodontology and oral implantology, owing to their ability to rapidly stimulate vascularization of tissues (Miron et al., 2017). The rationale for utilising platelet concentrates is that these are the primary cells involved in wound healing, and they initiate the coagulation cascade, resulting in the formation of a fibrin meshwork that works as a provisional matrix, maintaining the space for regeneration. The preparation of platelets concentrates is based on the principle of the centrifugation process to separate particles of different densities. The potential benefits of platelet rich fibrin(PRF) obtained by horizontal method of centrifugation, in management of gingival recession has not yet been clearly established . Therefore, we propose this research to evaluate the clinical efficacy of H-PRF in management of Cairo’s RT1 and RT2 recessions in maxillary anteriors and premolars along with coronally advanced flap (CAF) and to compare the outcomes with that of PRF obtained by angle spin protocol.
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