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PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS

Phase 2
Completed
Conditions
Periodontitis
Interventions
Registration Number
NCT02119520
Lead Sponsor
Government Dental College and Research Institute, Bangalore
Brief Summary

Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis subjects.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
96
Inclusion Criteria

the presence of 3- wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing [SRP]) in asymptomatic teeth.

Exclusion Criteria
  1. Agressive Periodontitis subjects; 2) Systemic conditions known to affect the periodontal status; 3) medications known to affect the outcomes of periodontal therapy; 4) Hematological disorders and insufficient platelet count (<200,000/mm3); 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Platelet rich fibrin + atorvastatinPlatelet rich fibrin +AtorvastatinIn Platelet rich fibrin+ATV group PRF combined with 10 µl of 1.2% ATV was inserted into the depth of the IBD
Platelet rich fibrinPlatelet rich fibrinIn Platelet rich fibrin group PRF was inserted into the depth of the IBD.
Open flap debridementopen flap debridementopen flap debridement was followed by no grafting or regenerative intervention.
Primary Outcome Measures
NameTimeMethod
Percentage radiographic defect depth reduction9 months from baseline

Defect depth reduction will be assessed from baseline to 9 month post operatively on radiographs

Secondary Outcome Measures
NameTimeMethod
change in probing depth9 months from baseline

probing depth will be assessed from gingival margin to pocket depth at baseline and 9 months postoperatively

change in relative attachment level9 months from baseline

RAL will be assesed from fixed point on the stent at baseline and 9 months postoperatively

change in plaque levels9 months from baseline

plaque levels were assessed at baseline and 9 months postoperatively

change in gingival bleeding9 months from baseline

gingival bleeding was assesed at baseline and 9 months postoperatively

change in gingival margin levels9 months from baseline

change in gingival margin levels were assesed at baseline and 9 months

Trial Locations

Locations (1)

Govt dental college and research institute

🇮🇳

Bangalore, Karnataka, India

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