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Completed

NCT Number: NCT02903108

Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis

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.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Bangalore, Karnataka, 560002, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SRP plus boric acid gel

Drug

SRP followed by 0.75% boric acid placement into intrabony defect

SRP plus placebo gel

Drug

SRP followed by placebo gel placement into intrabony defect

Primary outcomes

  1. Defect depth reduction (%)

    Time frame: Change from baseline to 6 months

    assessed in percentage

Secondary outcomes

  1. probing depth (mm)

    Time frame: Change from baseline to 6 months

    measured in mm

  2. clinical attachment level (mm)

    Time frame: Change from baseline to 6 months

    measured in mm

  3. modified sulcus bleeding index

    Time frame: Change from baseline to 6 months

    scale from 0-3

  4. plaque index

    Time frame: Change from baseline to 6 months

    scale from 0-3

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 16, 2016
Registry last updated
Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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