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Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis

G

Government Dental College and Research Institute, Bangalore

Status and phase

Completed
Phase 3
Phase 2

Conditions

Chronic Periodontitis

Treatments

Drug: SRP plus placebo gel
Drug: SRP plus boric acid gel

Study type

Interventional

Funder types

Other

Identifiers

NCT02903108
GDCRI/ACM/PG/PhD/2/2013-2014O

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

39 participants in 2 patient groups, including a placebo group

Boric acid group
Active Comparator group
Description:
Oral prophylaxis followed by 0.75% boric acid drug in gel form placed in intrabony defects
Treatment:
Drug: SRP plus boric acid gel
Placebo group
Placebo Comparator group
Description:
Oral prophylaxis followed by placebo gel placement in intrabony defects
Treatment:
Drug: SRP plus placebo gel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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