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Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis

Platelet - Rich Fibrin Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02120872
Enrollment
90
Registered
2014-04-23
Start date
2013-02-28
Completion date
2014-01-31
Last updated
2014-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Three Wall Intrabony Defects in Chronic Periodontitis

Brief summary

The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.

Detailed description

90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.

Interventions

DRUGPlatelet rich fibrin and simvastatin

Three wall intrabony defect sites treated with Open Flap Debridement. 0.1 mL prepared SMV gel (1.2 mg/0.1 mL) was mixed with PRF. The PRF - SMV mixture was delivered to the defect.

BIOLOGICALPlatelet rich fibrin

Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.

Three wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect.

Sponsors

Government Dental College and Research Institute, Bangalore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Subjects with the diagnosis of chronic periodontitis * presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph \[IOPA\]) * interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth

Exclusion criteria

* Subjects, with the diagnosis of aggressive periodontitis, * with known systemic illness and taking medications known to affect the outcomes of periodontal therapy * insufficient platelet count (\< 200,000/mm3), * pregnancy / lactation * use of any form of tobacco * unacceptable oral hygiene (if plaque index \[PI\] (Silness & Loe 1964) \>1.5) after the reevaluation of phase I therapy * teeth with furcation defects * non-vital * mobility of tooth ≥ Grade II

Design outcomes

Primary

MeasureTime frame
The primary outcome measure of the study was defect depth reduction evaluated radiographicallyAt baseline and 9 month after surgery

Secondary

MeasureTime frame
Relative Attachment LevelAt baseline and 9 month after syrgery
modified Sulcul Bleeding IndexAt baseline and 9 month after surgery
Plaque IndexAt baseline and 9 month after surgery
Probing DepthAt baseline and 9 month after surgery

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026