| CTRI Number |
CTRI/2025/03/082828 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of platelet concentrates versus probiotic augmented platelet concentrates in bone defects of teeth in stage III periodontitis patients |
|
Scientific Title of Study
|
Effect of injectable platelet rich fibrin vs probiotic[Bifidobacterium[2x10^9CFU/G] augmented injectable platelet rich fibrin in intra osseous defects of stage III periodontitis patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Digavinti Sushmitha |
| Designation |
Post Graduate student |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Vydehi Institute of Dental Sciences and Research Centre, Department of Periodontics, Room no 6, 2nd floor
Bangalore
KARNATAKA
560066
India |
| Phone |
8885655541 |
| Fax |
|
| Email |
digavintisushmitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruthi S |
| Designation |
Reader |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Vydehi institute of Dental Sciences and Research Centre, Department of Periodontics, Room no 6, 2nd floor
Bangalore
KARNATAKA
560066
India |
| Phone |
9886824276 |
| Fax |
|
| Email |
shruthi_s1984@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruthi S |
| Designation |
Reader |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Vydehi Institute of Dental Sciences and Research Centre, Department of Periodontics, Room no 6, 2nd floor
Bangalore
KARNATAKA
560066
India |
| Phone |
9886824276 |
| Fax |
|
| Email |
shruthi_s1984@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vydehi Institute of Dental Sciences and Research centre, Whitefield,Bengaluru, Karnataka,India -560066 |
|
|
Primary Sponsor
|
| Name |
Digavinti Sushmitha |
| Address |
15-1-24-3,REDDEPPA NAIDU COLONY EXTENSION,C.T.M ROAD,MADANAPALLE,ANNAMAYYA DIST,ANDHRA PRADESH |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Digavinti Sushmitha |
Vydehi Institute of Dental Sciences and Research Centre |
Department of Periodontics, Room no 6, 2nd floor,82, Nallurhalli main road, Near BMTC 18TH Depot,Vijayanagar,Nallurhalli, Whitefield
Bangalore
KARNATAKA |
8885655541
digavintisushmitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VYDEHI ISTITUTE OF DENTAL SCIENCES- INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M897||Major osseous defect, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injectable platelet rich fibrin |
Injectable platelet rich fibrin will be formulated from patients own blood and placed in the intraosseous defects and will be reevaluated after 6months |
| Intervention |
Injectable platelet rich fibrin with probiotic |
Injectable platelet rich fibrin will be formulated from patients own blood and combined with probiotic and placed in the intraosseous defects and will be reevaluated after 6 months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Presence of 16 natural teeth,
Maxillary and mandibular molars with intraosseous defects |
|
| ExclusionCriteria |
| Details |
Medically compromised patients,
Patients on any medications known to affect the outcomes of periodontal therapy,
Insufficient platelet count,
Pregnant or lactating women.
• Smokers or subjects using any form of tobacco
• Furcation involvement more than 3mm
• Grade II and grade III mobility
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in probing pocket depth
Clinical attachment level gain
Radiographic bone defect fill
|
Baseline, 6months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decreased Bleeding on probing
Reduction in Plaque index score
|
Baseline,6months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/03/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nonsurgical therapy · Case history will be recorded in standard proforma after obtaining written consent · Oral Hygiene Instructions will be given and Scaling and Root planing will be performed to control supra and sub gingival plaque. · Clinical parameters and radiographic parameters will be evaluated at baseline, and 9 months after regenerative therapy. Clinical parameters · Plaque index (PI) (Silness and Loe, 1964). · Gingival index (GI) (Loe and Silness, 1963). · Probing pocket depth (PPD): will be measured at six sites around the teeth using UNC 15 probe. · Clinical attachment level (CAL): will be measured from the CEJ to the base of the pocket · Relative attachment level (RAL): will be measured from a reference point other than CEJ (stent) to the base of the pocket Radiographic parameters · All patients will undergo CBCT (Cone Beam Computed Tomography) for locating bony defects. · CBCT will be taken to obtain 3-dimensional visualization of intra bony defects. · Defects will be measured from Cemento enamel junction to alveolar crest. Surgical therapy: All routine tests will be carried out before starting the surgery. The surgical procedure will be performed under local anesthesia using 2% lignocaine hydrochloride containing adrenaline at a concentration of 1: 200000.A full thickness mucoperiosteal flap will be raised and the intra bony defect will be debrided and Injectable Platelet Rich Fibrin (I- PRF) will be obtained from the patient. The defect will be filled with I-PRF in Group A and I-PRF augmented with 1 gram probiotic [Bifidobacterium(2X109 CFU/g)] in Group B and suturing will be done. Injectable-Platelet Rich Fibrin: The I-PRF will be prepared following the protocol developed by Miron et al., intravenous blood (by venipuncturing of the antecubital vein) will be collected in 10-ml plastic tubes without anticoagulant and immediately centrifuged in centrifugation machine at 700 revolutions per minute for 3 minutes. The I- PRF will be collected from the top layer and used for regeneration in group A. In group B I- PRF would be mixed with I gram of probiotic containing Bifidobacterium animalis lactis resulting in a steak and will be placed into the defect. |