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Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin vs Titanium Platelet Rich Fibrin

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Open flap debridement (OFD)
OFD with Platelet rich fibrin (PRF)
OFD with Titanium Platelet rich fibrin (TPRF)
Sponsored by
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontal regeneration, Growth factors

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • presence of minimum 20 permanent teeth
  • age group 20-55 years
  • radiographic evidence of periodontal IBDs
  • probing pocket depth (PPD) >5mm in minimum two sextants in at least three teeth
  • clinical attachment (CA) loss of ≥ 3mm.

Exclusion Criteria:

  • Systemically compromised subjects
  • those on medications (corticosteroids/ bisphosphonate therapy) that may interfere with wound healing
  • grade III tooth mobility
  • smokers and alcoholic subjects
  • pregnant and lactating mothers
  • subjects who underwent periodontal treatment within a period of 1 year.

Sites / Locations

  • Government Dental College and Research Institute
  • The Oxford Dental College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

SRP with Open flap debridement (OFD) alone for treating periodontal pocket

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into bone defect

SRP with Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into bone defect

Outcomes

Primary Outcome Measures

defect depth reduction (DDR)
change in clinical attachment level (CAL)

Secondary Outcome Measures

change in probing pocket depths (PPD)
change in plaque index (PI)

Full Information

First Posted
July 23, 2015
Last Updated
July 29, 2015
Sponsor
Government Dental College and Research Institute, Bangalore
Collaborators
The Oxford Dental College, Hospital and Research Center, Bangalore, India
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1. Study Identification

Unique Protocol Identification Number
NCT02512952
Brief Title
Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin vs Titanium Platelet Rich Fibrin
Official Title
Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin and Titanium Platelet Rich Fibrin: A Randomized Clinical Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
Collaborators
The Oxford Dental College, Hospital and Research Center, Bangalore, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: To compare the effectiveness of open flap debridement (OFD) alone and OFD along with either Autologous Platelet Rich Fibrin (PRF) or Titanium Platelet Rich Fibrin (TPRF) in the treatment of intrabony defects (IBDs). Materials and methods: Study was conducted on subjects reporting to the Department of Periodontics, The Oxford Dental College and Hospital, Bangalore. 38 subjects with 90 periodontal IBDs of moderate to severe periodontitis were selected and assigned to OFD alone (group I) or OFD with Autologous PRF (group II) or OFD with TPRF (group III). In each subject, a minimum number of two sextants were present with probing pocket depths (PPD) ≥5mm in at least three teeth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontal regeneration, Growth factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
SRP with Open flap debridement (OFD) alone for treating periodontal pocket
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into bone defect
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
SRP with Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into bone defect
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement (OFD)
Intervention Description
Oral prophylaxis followed by Open flap debridement (OFD)
Intervention Type
Procedure
Intervention Name(s)
OFD with Platelet rich fibrin (PRF)
Intervention Description
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
Intervention Type
Procedure
Intervention Name(s)
OFD with Titanium Platelet rich fibrin (TPRF)
Intervention Description
Oral prophylaxis followed by Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into the bone defect
Primary Outcome Measure Information:
Title
defect depth reduction (DDR)
Time Frame
Change from baseline to 9 months
Title
change in clinical attachment level (CAL)
Time Frame
Change from baseline to 9 months
Secondary Outcome Measure Information:
Title
change in probing pocket depths (PPD)
Time Frame
Change from baseline to 9 months
Title
change in plaque index (PI)
Time Frame
Change from baseline to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: presence of minimum 20 permanent teeth age group 20-55 years radiographic evidence of periodontal IBDs probing pocket depth (PPD) >5mm in minimum two sextants in at least three teeth clinical attachment (CA) loss of ≥ 3mm. Exclusion Criteria: Systemically compromised subjects those on medications (corticosteroids/ bisphosphonate therapy) that may interfere with wound healing grade III tooth mobility smokers and alcoholic subjects pregnant and lactating mothers subjects who underwent periodontal treatment within a period of 1 year.
Facility Information:
Facility Name
Government Dental College and Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
The Oxford Dental College
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560068
Country
India

12. IPD Sharing Statement

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Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin vs Titanium Platelet Rich Fibrin

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