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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  
Status 
Not Applicable 
 
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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