Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis

September 15, 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 the present study was to evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing in chronic periodontitis (CP) patients.

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 with chronic periodontitis (CP) patients.

Methods: Thirty nine 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)

39

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

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

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemically healthy with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs
  • Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy

Exclusion Criteria:

  • Patients on systemic boron therapy
  • Known or suspected allergy to boron supplementation
  • Patients with aggressive periodontitis
  • Tobacco use in any form, smokers, alcoholics
  • Immunocompromised and systemically unhealthy patients
  • Pregnant or lactating females

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Boric acid group
Oral prophylaxis followed by 0.75% boric acid drug in gel form placed in intrabony defects
Drug: SRP plus boric acid gel
SRP followed by 0.75% boric acid placement into intrabony defect
Placebo Comparator: Placebo group
Oral prophylaxis followed by placebo gel placement in intrabony defects
Drug: SRP plus placebo gel
SRP followed by placebo gel placement into intrabony defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Defect depth reduction (%)
Time Frame: Change from baseline to 6 months
assessed in percentage
Change from baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
probing depth (mm)
Time Frame: Change from baseline to 6 months
measured in mm
Change from baseline to 6 months
clinical attachment level (mm)
Time Frame: Change from baseline to 6 months
measured in mm
Change from baseline to 6 months
modified sulcus bleeding index
Time Frame: Change from baseline to 6 months
scale from 0-3
Change from baseline to 6 months
plaque index
Time Frame: Change from baseline to 6 months
scale from 0-3
Change from baseline to 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

May 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDCRI/ACM/PG/PhD/2/2013-2014O

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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