NCT02512952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

July 23, 2015

Last Update Submit

July 29, 2015

Conditions

Periodontitis

Keywords

Periodontal regenerationGrowth factors

Outcome Measures

Primary Outcomes (2)

  • defect depth reduction (DDR)

    Change from baseline to 9 months

  • change in clinical attachment level (CAL)

    Change from baseline to 9 months

Secondary Outcomes (2)

  • change in probing pocket depths (PPD)

    Change from baseline to 9 months

  • change in plaque index (PI)

    Change from baseline to 9 months

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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

Procedure: Open flap debridement (OFD)

Group 2

ACTIVE COMPARATOR

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

Procedure: OFD with Platelet rich fibrin (PRF)

Group 3

ACTIVE COMPARATOR

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

Procedure: OFD with Titanium Platelet rich fibrin (TPRF)

Interventions

Open flap debridement (OFD)PROCEDURE

Oral prophylaxis followed by Open flap debridement (OFD)

Group 1
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

Group 2
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

Group 3

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

The Oxford Dental College

Bangalore, Karnataka, 560068, India

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 31, 2015

Study Start

June 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

IN(2)