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Clinical Trials/CTRI/2025/03/082828
CTRI/2025/03/082828
Not yet recruiting
Not Applicable

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

Digavinti Sushmitha1 site in 1 country28 target enrollmentStarted: March 28, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Digavinti Sushmitha
Enrollment
28
Locations
1
Primary Endpoint
Reduction in probing pocket depth

Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
35.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Presence of 16 natural teeth, Maxillary and mandibular molars with intraosseous defects.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Reduction in probing pocket depth

Time Frame: Baseline, 6months

Clinical attachment level gain

Time Frame: Baseline, 6months

Radiographic bone defect fill

Time Frame: Baseline, 6months

Secondary Outcomes

  • Decreased Bleeding on probing(Reduction in Plaque index score)

Investigators

Sponsor
Digavinti Sushmitha
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Digavinti Sushmitha

Vydehi Institute of Dental Sciences and Research Centre

Study Sites (1)

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