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

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 2

Conditions: Periodontitis

Treatments: Drug: Platelet rich fibrin +Atorvastatin; Drug: Platelet rich fibrin; Procedure: open flap debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT02119520

GDCRI/ACM/PG/PhD/2011-2012/D

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 3 patient groups

Platelet rich fibrin + atorvastatin

Active Comparator group

Description:

In Platelet rich fibrin+ATV group PRF combined with 10 µl of 1.2% ATV was inserted into the depth of the IBD

Treatment:

Drug: Platelet rich fibrin +Atorvastatin

Platelet rich fibrin

Sham Comparator group

Description:

In Platelet rich fibrin group PRF was inserted into the depth of the IBD.

Treatment:

Drug: Platelet rich fibrin

Open flap debridement

Other group

Description:

open flap debridement was followed by no grafting or regenerative intervention.

Treatment:

Procedure: open flap debridement