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

Primary Purpose

Periodontitis

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Platelet rich fibrin +Atorvastatin

Platelet rich fibrin

open flap debridement

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Surgery, Growth Factors, Statins

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Govt dental college and research institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Other

Arm Label

Platelet rich fibrin + atorvastatin

Platelet rich fibrin

Open flap debridement

Arm Description

In Platelet rich fibrin+ATV group PRF combined with 10 µl of 1.2% ATV was inserted into the depth of the IBD

In Platelet rich fibrin group PRF was inserted into the depth of the IBD.

open flap debridement was followed by no grafting or regenerative intervention.

Outcomes

Primary Outcome Measures

Percentage radiographic defect depth reduction

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

Secondary Outcome Measures

change in probing depth

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

change in relative attachment level

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

change in plaque levels

plaque levels were assessed at baseline and 9 months postoperatively

change in gingival bleeding

gingival bleeding was assesed at baseline and 9 months postoperatively

change in gingival margin levels

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

Full Information

NCT ID

NCT02119520

First Posted

April 17, 2014

Last Updated

April 17, 2014

Sponsor

Government Dental College and Research Institute, Bangalore

1. Study Identification

Unique Protocol Identification Number

NCT02119520

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Government Dental College and Research Institute, Bangalore

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

Keywords

Periodontitis, Surgery, Growth Factors, Statins

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Platelet rich fibrin + atorvastatin

Arm Type

Active Comparator

Arm Description

In Platelet rich fibrin+ATV group PRF combined with 10 µl of 1.2% ATV was inserted into the depth of the IBD

Arm Title

Platelet rich fibrin

Arm Type

Sham Comparator

Arm Description

In Platelet rich fibrin group PRF was inserted into the depth of the IBD.

Arm Title

Open flap debridement

Arm Type

Other

Arm Description

open flap debridement was followed by no grafting or regenerative intervention.

Intervention Type

Drug

Intervention Name(s)

Platelet rich fibrin +Atorvastatin

Intervention Type

Drug

Intervention Name(s)

Platelet rich fibrin

Intervention Type

Procedure

Intervention Name(s)

open flap debridement

Primary Outcome Measure Information:

Title

Percentage radiographic defect depth reduction

Description

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

Time Frame

9 months from baseline

Secondary Outcome Measure Information:

Title

change in probing depth

Description

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

Time Frame

9 months from baseline

Title

change in relative attachment level

Description

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

Time Frame

9 months from baseline

Title

change in plaque levels

Description

plaque levels were assessed at baseline and 9 months postoperatively

Time Frame

9 months from baseline

Title

change in gingival bleeding

Description

gingival bleeding was assesed at baseline and 9 months postoperatively

Time Frame

9 months from baseline

Title

change in gingival margin levels

Description

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

Time Frame

9 months from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Avani R Pradeep, MDS

Organizational Affiliation

Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Govt dental college and research institute

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560002

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

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