| 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. |
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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 |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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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.
|
|
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
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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. |
|
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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.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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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. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Root Coverage Esthetic Score (RCES): Cairo et. al. (2009) |
6 months, 1 year, 2 year. |
|
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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" |
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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. |