Clinical trial NCT02645227: Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment
Official title: Platelet-rich Fibrin With 1.2% Rosuvastatin for the Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients

Detailed description: ABSTRACT Background: Regenerative periodontal therapy encompasses the use of various bioactive agents that are not only inflammo-modulatory but also osteoclast-inhibitory or rather, osteostimulative. The hypolipidaemic Statin group of drugs, particularly Rosuvastatin (RSV), are known to be associated with alveolar bone formation and periodontal improvements. Platelet analogues like Platelet rich fibrin (PRF), being rich sources of growth factors, have also come into widespread periodontal regenerative use. The aim of the study is to evaluate and compare the efficacy of open-ﬂap debridement (OFD) with or without PRF or PRF + 1.2% RSV gel in the treatment of intrabony defects (IBDs) in chronic periodontitis (CP) patients.

Methods: Ninety individuals with a total of 90 IBDs were randomly assigned to one of the 3 treatment groups: 1) OFD alone, 2) OFD + PRF and 3) OFD + PRF + 1.2% RSV gel placement. Plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment (CA) level and IBD depth were recorded at baseline and at 9 months post-operatively.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy with CP diagnosis16 having probing depth (PD) ≥5mm, clinical attachment (CA) level ≥3mm and vertical bone loss ≥3mm on intraoral periapical radiographs (IOPAR) without any antibiotic or periodontal therapy in the last 6 months.

Exclusion Criteria:

* History of statin allergy, statin therapy, any systemic condition or medication altering the periodontal condition, immune-compromised state, hematologic disorders, insufﬁcient platelet count (\<200,000/mm3), aggressive periodontitis, substance/tobacco abuse and lactating and pregnant females.

Primary outcomes:
measure: defect depth reduction (%)
timeFrame: Change from baseline to 9 months
Secondary outcomes:
measure: probing depth (mm)
timeFrame: Change from baseline to 9 months
measure: clinical attachment level (mm)
timeFrame: Change from baseline to 9 months
measure: modified sulcus bleeding index
timeFrame: Change from baseline to 9 months
measure: plaque index
timeFrame: Change from baseline to 9 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Government Dental College and Research Institute
state: Karnataka
Study officials:
affiliation: Government Dental Colleege & Research Institute, Bangalore
name: Avani Pradeep, MDS
role: STUDY_DIRECTOR
References: