Boric Acid in Degree 2 Furcation Defect

April 13, 2016 updated by: Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Clinical Efficacy of Subgingivally Delivered 0.75% Boric Acid Gel as an Adjunct to Mechanotherapy in Chronic Periodontitis: A Randomized Controlled Clinical Trial

The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo gel alone in patients with chronic periodontitis (CP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo gel alone in patients with chronic periodontitis (CP).

Methods:FORTY EIGHT systemically healthy patients with CP are included in this study. They were divided into two groups: 1) SRP + 0.75% Boric acid gel (BA group); 2) SRP + Placebo gel (Placebo group). At baseline, 3 month, and 6 months after treatment, clinical measurements, including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in radiographic defect depth reduction (DDR%) were assessed.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Government Dental College and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1
Scaling and Root Planing (SRP) with 0.75% BORIC ACID GEL for treating furcation defect
Drug: 0.75 % Boric Acid
After Scaling and Root Planing placement of 0.75% Boric Acid gel in Mandibular degree 2 Furcation defect.
PLACEBO_COMPARATOR: Group 2
Scaling and Root Planing (SRP) with PLACEBO GEL for treating furcation defect.
Drug: placebo
After Scaling and Root Planing placement of Placebo gel in Mandibular degree 2 Furcation defect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic bone fill
Time Frame: Baseline to 6 months
assessed in percentage
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
probing depth
Time Frame: 3 and 6 months
measured in mm
3 and 6 months
Relative vertical attachment leve
Time Frame: 3 and 6 months
measured in mm
3 and 6 months
Relative horizontal attachment level
Time Frame: 3 and 6 months
measured in mm
3 and 6 months
modified sulcus bleeding index
Time Frame: 3 and 6 months
0-3 scale
3 and 6 months
plaque index
Time Frame: 3 and 6 months
0-3 scale
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Government Dental College and Research Institute, Bangalore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (ESTIMATE)

April 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDCRI/ACM/PG/PhD/2/2013-2014ZM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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