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

Phase 2

Completed

• Conditions: Periodontitis
• Interventions: Procedure: OFD with Titanium Platelet rich fibrin (TPRF); Procedure: Open flap debridement (OFD); Procedure: OFD with Platelet rich fibrin (PRF)

• Registration Number: NCT02512952
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-07
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-29
• Last Update Submitted: 2015-07-29
• Study First Posted: 2015-07-31
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	OFD with Titanium Platelet rich fibrin (TPRF)	SRP with Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into bone defect
Group 1	Open flap debridement (OFD)	SRP with Open flap debridement (OFD) alone for treating periodontal pocket
Group 2	OFD with Platelet rich fibrin (PRF)	SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into bone defect

Primary Outcome Measures

Name	Time	Method
defect depth reduction (DDR)	Change from baseline to 9 months
change in clinical attachment level (CAL)	Change from baseline to 9 months

Secondary Outcome Measures

Name	Time	Method
change in probing pocket depths (PPD)	Change from baseline to 9 months
change in plaque index (PI)	Change from baseline to 9 months

Trial Locations

Locations (2)

Government Dental College and Research Institute; 🇮🇳 Bangalore, Karnataka, India

The Oxford Dental College; 🇮🇳 Bangalore, Karnataka, India