FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062289 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 31/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Surgical/Anesthesia
Dentistry 
Study Design  Other 
Public Title of Study   A Comparative evaluation of Platelet Rich Fibrin Matrix (PRFM) AND Coronally Advanced Flap(CAF) with and without Peripheral Blood Mesenchymal Stem Cells (PBMSCs) in the surgical management of Gingival Recession Type 1 – A Split-mouth Randomised Controlled Trial. 
Scientific Title of Study   A Comparative evaluation of Platelet Rich Fibrin Matrix (PRFM) AND Coronally Advanced Flap(CAF) with and without Peripheral Blood Mesenchymal Stem Cells (PBMSCs) in the surgical management of Gingival Recession Type 1 – A Split-mouth Randomised 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 JEEVIKA A DAS 
Designation  POST-GRADUATE STUDENT, DEPARTMENT OF PERIODONTICS, K.L.E. SOCIETY’S INSTITUTE OF DENTAL SCIENCES. 
Affiliation  K.L.E. SOCIETY’S INSTITUTE OF DENTAL SCIENCES 
Address  ROOM NO. 5, DEPARTMENT OF PERIODONTICS, K.L.E. SOCIETY’S INSTITUTE OF DENTAL SCIENCES, #20, YESHWANTHPUR SUBURB, II STAGE, TUMKUR ROAD, BENGALURU – 560 022.
#104, A block, Gangothri Galaxy, 5th Cross, Umarbagh Layout, Banashankari Temple Ward, Bengaluru, Karnataka-560078
Bangalore
KARNATAKA
560022
India 
Phone  9916161197  
Fax    
Email  jad.jgd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SPHOORTHI A BELLUDI 
Designation  PROFESSOR AND HEAD, DEPARTMENT OF PERIODONTICS.  
Affiliation  RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES 
Address  K.L.E. SOCIETY’S INSTITUTE OF DENTAL SCIENCES, #20, YESHWANTHPUR SUBURB, II STAGE, TUMKUR ROAD, BENGALURU – 560 022.

Bangalore
KARNATAKA
560022
India 
Phone  9916010380  
Fax    
Email  doc_sphoo@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR JEEVIKA A DAS 
Designation  POSTGRADUATE STUDENT, DEPARTMENT OF PERIODONTICS, K.L.E. SOCIETY’S INSTITUTE OF DENTAL SCIENCES 
Affiliation  RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES 
Address  ROOM NO. 5, DEPARTMENT OF PERIODONTICS, K.L.E. SOCIETY’S INSTITUTE OF DENTAL SCIENCES, #20, YESHWANTHPUR SUBURB, II STAGE, TUMKUR ROAD, BENGALURU – 560 022.

Bangalore
KARNATAKA
560022
India 
Phone  9916161197  
Fax    
Email  jad.jgd@gmail.com  
 
Source of Monetary or Material Support  
Room no. 5, Department of Periodontics, K.L.E. Societys Institute of Dental Sciences, #20,Yeshwanthpur Suburb, II Stage, Tumkur Road, BENGALURU – 560 022.  
 
Primary Sponsor  
Name  DR JEEVIKA A DAS  
Address  DEPARTEMNT OF PERIODONTICS, K.L.E. SOCIETY’S INSTITUTE OF DENTAL SCIENCES, #20, YESHWANTHPUR SUBURB, II STAGE, TUMKUR ROAD, BENGALURU – 560 022. KARNATAKA India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR JEEVIKA A DAS   K.L.E. SOCIETYS INTITUTE OF DENTAL SCIENCES, BENGALURU-560022  Room no. 5, Department of Periodontics, K.L.E. Societys Institute of Dental Sciences, #20, Tumkur Road, Yeshwanthpur Suburb, II Stage, Bengaluru-560022.
Bangalore
KARNATAKA 
9916161197

jad.jgd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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  PBMSCs and PRFM (Supercell)  During the mucogingival surgical procedure, lasting for about 2 hours; Following optimum anaesthesia and reflection of a mucoperiosteal flap, thorough debridement will be done. Subsequently, the defect will be filled with PBMSCs and PRFM (Supercell) in the test sites. 
Comparator Agent  PRFM  During the mucogingival surgical procedure, lasting for about 2 hours; Following optimum anaesthesia and reflection of a mucoperiosteal flap, thorough debridement will be done. Subsequently, the defect will be filled with PRFM in the control sites. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Systemically healthy male and female subjects in the age group of 20-50 years, with gingival recession type 1 defect on at least 2 adjacent teeth, with no radiographic evidence of interdental bone loss.
Probing pocket depth ≤ 3 mm.
Adequate width of attached gingiva.
 
 
ExclusionCriteria 
Details  Pregnant/lactating women.
Patients on drug therapy known to affect the number and function of platelets in the past 3 months.
Patients with abnormal platelet count or having disease affecting platelet count.
Patients with immunologic diseases.
Current and former smokers.
Patients having a history of periodontal therapy in the last 6 months.
Any other contraindications for periodontal surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Plaque Index (PI): Silness and Loe (1964)
2. Gingival Index (GI): Loe and Silness (1963)
3. Vertical Component Of The Gingival Recession (VGR)
4. Horizontal Component Of The Gingival Recession (HGR)
5. Probing Pocket Depth (PPD)
6. Clinical Attachment Level (CAL)
7. Width of Attached Gingiva (WAG)
8. Width of Keratinized Gingiva (KG)
9. Gingival Thickness (GT)

 
Baseline, 3 months, 6 months, 1 year, and 2 year. 
 
Secondary Outcome  
Outcome  TimePoints 
Root Coverage Esthetic Score (RCES): Cairo et. al. (2009)  6 months, 1 year, 2 year. 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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 4 
Date of First Enrollment (India)   15/02/2024 
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="4"
Months="0"
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  

This is a split-mouth, double-blind, randomised controlled clinical trial for comparing the Platelet-Rich Fibrin Matrix (PRFM) and Coronally Advanced Flap (CAF) with and without Peripheral Blood Mesenchymal Stem Cells (PBMSCS) in the surgical management of gingival recession type – 1 for the evaluation of the root coverage potential, regenerative effects, and the impact on gingival thickness.. The sites will be randomly assigned by computer-generated tabulation method into: 1. Test group: treated with CAF and PBMSCS + PRFM (SUPERCELL). 2. Control group: treated with CAF and PRFM alone. The period of study will be divided into a screening phase, a pre-treatment phase, a treatment phase, and a post-treatment phase. The subjects will be recruited after meeting the inclusion and exclusion criteria and obtaining the informed consent during the screening phase. In pre-treatment phase all patients will initially receive phase i therapy consisting of scaling, root planing, and oral hygiene instructions. Clinical parameters like Plaque Index (Pi):  Silness And Loe, Gingival Index (Gi): Loe And Silness, Vertical Component Of The Gingival Recession, Horizontal Component Of The Gingival Recession, Probing Pocket Depth, Clinical Attachment Level, Width Of Attached Gingiva, Width Of Keratinized Gingiva, Gingival Thickness And Root Coverage Esthetic Score will be recorded at baseline, 3 months, 6 months, 1 year and 2 years. The treatment phase will involve withdrawal of blood for the procurement of PRFM and PBMSCs under aseptic conditions. This will be followed by obtaining optimum anaesthesia and reflection of a mucoperiosteal flap, followed by thorough debridement. Subsequently, the defect will be filled with PBMSCS + PRFM (SUPERCELL) in test sites and with PRFM in control sites. The surgical flaps which were elevated will be advanced coronally and sutured. A periodontal pack will be applied. All patients will be prescribed post-operative analgesics and antibiotics.  In the post-treatment phase, recall examinations and maintenance therapy will be scheduled at 1 week, 3, and 6 months, 1 year and 2 years postoperatively. Clinical photographs will be recorded at various stages in the period of the study. The data gathered from the study will be subjected to appropriate statistical analysis. 

 
Close