NCT02609061

Brief Summary

The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

November 15, 2015

Last Update Submit

November 17, 2015

Conditions

Furcation Defects

Outcome Measures

Primary Outcomes (1)

  • Radiographic bone fill

    assessed in percentage

    baseline to 9 months

Secondary Outcomes (5)

  • probing depth

    baseline to 9 months

  • Relative vertical attachment level

    baseline to 9 months

  • Relative horizontal attachment level

    baseline to 9 months

  • modified sulcus bleeding index

    baseline to 9 months

  • plaque index

    baseline to 9 months

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect

Procedure: Open flap debridement (OFD)

Group 2

ACTIVE COMPARATOR

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect

Procedure: OFD with Platelet rich fibrin (PRF)

Group 3

ACTIVE COMPARATOR

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate for treating furcation defect

Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel form

Interventions

Open flap debridement (OFD)PROCEDURE

Open flap debridement (OFD) alone

Group 1
OFD with Platelet rich fibrin (PRF)PROCEDURE

Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement

Group 2
OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel formPROCEDURE

Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate gel placement

Group 3

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of buccal Class II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);
  • No history of antibiotic or periodontal therapy in the preceding 6 months.

You may not qualify if:

  • Systemic conditions known to affect the periodontal status;
  • Medications known to affect the outcomes of periodontal therapy;
  • Hematological disorders and insufficient platelet count (\<200,000/mm3);
  • Pregnancy/lactation;
  • Smoking and tobacco use in any form
  • Immunocompromised individuals;
  • Those having unacceptable oral hygiene (plaque index \[PI\] \>1.5).
  • Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II
  • Aggressive periodontitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

Related Publications (1)

  • Kanoriya D, Pradeep AR, Garg V, Singhal S. Mandibular Degree II Furcation Defects Treatment With Platelet-Rich Fibrin and 1% Alendronate Gel Combination: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):250-258. doi: 10.1902/jop.2016.160269. Epub 2016 Oct 7.

    PMID: 27712462DERIVED

MeSH Terms

Conditions

Furcation Defects

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head, Dept of Periodontology

Study Record Dates

First Submitted

November 15, 2015

First Posted

November 20, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

IN(1)