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

Periodontitis Clinical Trial

Official title:

Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin and Titanium Platelet Rich Fibrin: A Randomized Clinical Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512952
• Other study ID #: 224/2013-14
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 23, 2015
• Last updated: July 29, 2015
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Open flap debridement (OFD)
Oral prophylaxis followed by Open flap debridement (OFD)
• OFD with Platelet rich fibrin (PRF)
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
• OFD with Titanium Platelet rich fibrin (TPRF)
Oral prophylaxis followed by Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into the bone defect

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka
India	The Oxford Dental College	Bangalore	Karnataka

Sponsors (2)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore	The Oxford Dental College, Hospital and Research Center, Bangalore, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	defect depth reduction (DDR)		Change from baseline to 9 months	No
Primary	change in clinical attachment level (CAL)		Change from baseline to 9 months	No
Secondary	change in probing pocket depths (PPD)		Change from baseline to 9 months	No
Secondary	change in plaque index (PI)		Change from baseline to 9 months	No