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Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis

Primary Purpose

Three Wall Intrabony Defects in Chronic Periodontitis

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Platelet rich fibrin and simvastatin

Platelet rich fibrin

Open Flap Debridement alone

About this trial

This is an interventional treatment trial for Three Wall Intrabony Defects in Chronic Periodontitis

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects with the diagnosis of chronic periodontitis
presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph [IOPA])
interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth

Exclusion Criteria:

Subjects, with the diagnosis of aggressive periodontitis,
with known systemic illness and taking medications known to affect the outcomes of periodontal therapy
insufficient platelet count (< 200,000/mm3),
pregnancy / lactation
use of any form of tobacco
unacceptable oral hygiene (if plaque index [PI] (Silness & Loe 1964) >1.5) after the reevaluation of phase I therapy
teeth with furcation defects
non-vital
mobility of tooth ≥ Grade II

Sites / Locations

Government Dental College and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Other

Arm Label

PRF and SMV Group

PRF Group

OFD Group

Arm Description

sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin

sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin

sites treated with Open Flap Debridement i.e. conventional flap surgery

Outcomes

Primary Outcome Measures

The primary outcome measure of the study was defect depth reduction evaluated radiographically

Secondary Outcome Measures

Probing Depth

Relative Attachment Level

modified Sulcul Bleeding Index

Plaque Index

Full Information

NCT ID

NCT02120872

First Posted

April 17, 2014

Last Updated

April 19, 2014

Sponsor

Government Dental College and Research Institute, Bangalore

1. Study Identification

Unique Protocol Identification Number

NCT02120872

Brief Title

Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis

Official Title

Platelet - Rich Fibrin Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.

Detailed Description

90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.

6. Conditions and Keywords

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

Three Wall Intrabony Defects in Chronic Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRF and SMV Group

Arm Type

Active Comparator

Arm Description

sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin

Arm Title

PRF Group

Arm Type

Sham Comparator

Arm Description

sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin

Arm Title

OFD Group

Arm Type

Other

Arm Description

sites treated with Open Flap Debridement i.e. conventional flap surgery

Intervention Type

Drug

Intervention Name(s)

Platelet rich fibrin and simvastatin

Intervention Description

Three wall intrabony defect sites treated with Open Flap Debridement. 0.1 mL prepared SMV gel (1.2 mg/0.1 mL) was mixed with PRF. The PRF - SMV mixture was delivered to the defect.

Intervention Type

Biological

Intervention Name(s)

Platelet rich fibrin

Intervention Description

Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.

Intervention Type

Procedure

Intervention Name(s)

Open Flap Debridement alone

Intervention Description

Three wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect.

Primary Outcome Measure Information:

Title

The primary outcome measure of the study was defect depth reduction evaluated radiographically

Time Frame

At baseline and 9 month after surgery

Secondary Outcome Measure Information:

Title

Probing Depth

Time Frame

At baseline and 9 month after surgery

Title

Relative Attachment Level

Time Frame

At baseline and 9 month after syrgery

Title

modified Sulcul Bleeding Index

Time Frame

At baseline and 9 month after surgery

Title

Plaque Index

Time Frame

At baseline and 9 month after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with the diagnosis of chronic periodontitis presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph [IOPA]) interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth Exclusion Criteria: Subjects, with the diagnosis of aggressive periodontitis, with known systemic illness and taking medications known to affect the outcomes of periodontal therapy insufficient platelet count (< 200,000/mm3), pregnancy / lactation use of any form of tobacco unacceptable oral hygiene (if plaque index [PI] (Silness & Loe 1964) >1.5) after the reevaluation of phase I therapy teeth with furcation defects non-vital mobility of tooth ≥ Grade II

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Avani R Pradeep, MDS

Organizational Affiliation

Government Dental College and Research Institute, Bangalore

Official's Role

Principal Investigator

Facility Information:

Facility Name

Government Dental College and Research Institute

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560002

Country

India

12. IPD Sharing Statement

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Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis

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