PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 17, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedApril 21, 2014
April 1, 2014
1 year
April 17, 2014
April 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage radiographic defect depth reduction
Defect depth reduction will be assessed from baseline to 9 month post operatively on radiographs
9 months from baseline
Secondary Outcomes (5)
change in probing depth
9 months from baseline
change in relative attachment level
9 months from baseline
change in plaque levels
9 months from baseline
change in gingival bleeding
9 months from baseline
change in gingival margin levels
9 months from baseline
Study Arms (3)
Platelet rich fibrin + atorvastatin
ACTIVE COMPARATORIn Platelet rich fibrin+ATV group PRF combined with 10 µl of 1.2% ATV was inserted into the depth of the IBD
Platelet rich fibrin
SHAM COMPARATORIn Platelet rich fibrin group PRF was inserted into the depth of the IBD.
Open flap debridement
OTHERopen flap debridement was followed by no grafting or regenerative intervention.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Govt dental college and research institute
Bangalore, Karnataka, 560002, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avani R Pradeep, MDS
Professor
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 17, 2014
First Posted
April 21, 2014
Study Start
February 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
April 21, 2014
Record last verified: 2014-04