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

NCT ID: NCT02512952

Last Updated: 2015-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Periodontitis

Keywords

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Periodontal regeneration Growth factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

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

Group Type ACTIVE_COMPARATOR

Open flap debridement (OFD)

Intervention Type PROCEDURE

Oral prophylaxis followed by Open flap debridement (OFD)

Group 2

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

Group Type ACTIVE_COMPARATOR

OFD with Platelet rich fibrin (PRF)

Intervention Type PROCEDURE

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

Group 3

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

Group Type ACTIVE_COMPARATOR

OFD with Titanium Platelet rich fibrin (TPRF)

Intervention Type PROCEDURE

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

Interventions

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Open flap debridement (OFD)

Oral prophylaxis followed by Open flap debridement (OFD)

Intervention Type PROCEDURE

OFD with Platelet rich fibrin (PRF)

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role lead

Responsible Party

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Dr. A R Pradeep

Professor and Head

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Government Dental College and Research Institute

Bangalore, Karnataka, India

Site Status

The Oxford Dental College

Bangalore, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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224/2013-14

Identifier Type: -

Identifier Source: org_study_id