Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: SRP plus boric acid gel; Drug: SRP plus placebo gel

• Registration Number: NCT02903108
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

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.

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 Timeline

• Study Start: 2015-05
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-09
• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-15
• Last Update Submitted: 2016-09-15
• Study First Posted: 2016-09-16
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boric acid group	SRP plus boric acid gel	Oral prophylaxis followed by 0.75% boric acid drug in gel form placed in intrabony defects
Placebo group	SRP plus placebo gel	Oral prophylaxis followed by placebo gel placement in intrabony defects

Primary Outcome Measures

Name	Time	Method
Defect depth reduction (%)	Change from baseline to 6 months	assessed in percentage

Secondary Outcome Measures

Name	Time	Method
clinical attachment level (mm)	Change from baseline to 6 months	measured in mm
modified sulcus bleeding index	Change from baseline to 6 months	scale from 0-3
plaque index	Change from baseline to 6 months	scale from 0-3
probing depth (mm)	Change from baseline to 6 months	measured in mm