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Completed

NCT Number: NCT02119520

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Govt dental college and research institute

Bangalore, Karnataka, 560002, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Platelet rich fibrin +Atorvastatin

Drug

Platelet rich Fibrin

Drug

Open Flap debridement

Procedure

Primary outcomes

  1. Percentage radiographic defect depth reduction

    Time frame: 9 months from baseline

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

Secondary outcomes

  1. change in probing depth

    Time frame: 9 months from baseline

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

  2. change in relative attachment level

    Time frame: 9 months from baseline

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

  3. change in plaque levels

    Time frame: 9 months from baseline

    plaque levels were assessed at baseline and 9 months postoperatively

  4. change in gingival bleeding

    Time frame: 9 months from baseline

    gingival bleeding was assesed at baseline and 9 months postoperatively

  5. change in gingival margin levels

    Time frame: 9 months from baseline

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

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2014
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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