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

Periodontitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119520
• Other study ID #: GDCRI/ACM/PG/PhD/2011-2012/D
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2014
• Last updated: April 17, 2014
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• Platelet rich fibrin +Atorvastatin

• Platelet rich fibrin

Procedure:
• open flap debridement

Locations

Country	Name	City	State
India	Govt dental college and research institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage radiographic defect depth reduction	Defect depth reduction will be assessed from baseline to 9 month post operatively on radiographs	9 months from baseline	No
Secondary	change in probing depth	probing depth will be assessed from gingival margin to pocket depth at baseline and 9 months postoperatively	9 months from baseline	No
Secondary	change in relative attachment level	RAL will be assesed from fixed point on the stent at baseline and 9 months postoperatively	9 months from baseline	No
Secondary	change in plaque levels	plaque levels were assessed at baseline and 9 months postoperatively	9 months from baseline	No
Secondary	change in gingival bleeding	gingival bleeding was assesed at baseline and 9 months postoperatively	9 months from baseline	No
Secondary	change in gingival margin levels	change in gingival margin levels were assesed at baseline and 9 months	9 months from baseline	No