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
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
Digavinti Sushmitha
Vydehi Institute of Dental Sciences and Research Centre