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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02119520
Enrollment
96
Registered
2014-04-21
Start date
2013-02-28
Completion date
2014-02-28
Last updated
2014-04-21

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

Conditions

Periodontitis

Keywords

Periodontitis, Surgery, Growth Factors, Statins

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.

Interventions

DRUGPlatelet rich fibrin +Atorvastatin
DRUGPlatelet rich fibrin
PROCEDUREopen flap debridement

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 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage radiographic defect depth reduction9 months from baselineDefect depth reduction will be assessed from baseline to 9 month post operatively on radiographs

Secondary

MeasureTime frameDescription
change in probing depth9 months from baselineprobing depth will be assessed from gingival margin to pocket depth at baseline and 9 months postoperatively
change in relative attachment level9 months from baselineRAL will be assesed from fixed point on the stent at baseline and 9 months postoperatively
change in plaque levels9 months from baselineplaque levels were assessed at baseline and 9 months postoperatively
change in gingival bleeding9 months from baselinegingival bleeding was assesed at baseline and 9 months postoperatively
change in gingival margin levels9 months from baselinechange in gingival margin levels were assesed at baseline and 9 months

Countries

India

Outcome results

None listed

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