Treatment of Periodontal Intrabony Defects Using Autologo... | NCT02512952

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jul 23, 2015

First Submission Date that Met QC Criteria

Jul 29, 2015

First Posted Date

Jul 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. A R Pradeep, Professor and Head, Government Dental College and Research Institute, BangalorePrincipal Investigator

Lead Sponsor

Government Dental College and Research Institute, BangaloreOTHER

Collaborators

Name	Class
The Oxford Dental College, Hospital and Research Center, Bangalore, India	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Open flap debridement (OFD)	Procedure	Oral prophylaxis followed by Open flap debridement (OFD)	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
defect depth reduction (DDR)		Change from baseline to 9 months
change in clinical attachment level (CAL)		Change from baseline to 9 months

Secondary Outcomes

Measure	Description	Time Frame
change in probing pocket depths (PPD)		Change from baseline to 9 months
change in plaque index (PI)		Change from baseline to 9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Government Dental College and Research Institute		Bangalore	Karnataka	560002	India
The Oxford Dental College

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases