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OpenTrials
Completed

NCT Number: NCT02512952

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Government Dental College and Research Institute, Bangalore, Karnataka, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open Flap Debridement (OFD)

Procedure

Oral prophylaxis followed by Open flap debridement (OFD)

OFD with Platelet rich fibrin (PRF)

Procedure

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)

Procedure

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

Primary outcomes

  1. defect depth reduction (DDR)

    Time frame: Change from baseline to 9 months

  2. change in clinical attachment level (CAL)

    Time frame: Change from baseline to 9 months

Secondary outcomes

  1. change in probing pocket depths (PPD)

    Time frame: Change from baseline to 9 months

  2. change in plaque index (PI)

    Time frame: Change from baseline to 9 months

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Collaborators

  • The Oxford Dental College, Hospital and Research Center, Bangalore, India

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2015
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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