Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis

NCT02903108 | Completed Phase 2

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2013-2014O
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Defect depth reduction (%)

  assessed in percentage

  Change from baseline to 6 months

Secondary Outcomes (4)

• probing depth (mm)

  Change from baseline to 6 months

• clinical attachment level (mm)

  Change from baseline to 6 months

• modified sulcus bleeding index

  Change from baseline to 6 months

• plaque index

  Change from baseline to 6 months

Study Arms (2)

Boric acid group

ACTIVE COMPARATOR

Oral prophylaxis followed by 0.75% boric acid drug in gel form placed in intrabony defects

Drug: SRP plus boric acid gel

Placebo group

PLACEBO COMPARATOR

Oral prophylaxis followed by placebo gel placement in intrabony defects

Drug: SRP plus placebo gel

Interventions

SRP plus boric acid gel DRUG

SRP followed by 0.75% boric acid placement into intrabony defect

Boric acid group

SRP plus placebo gel DRUG

SRP followed by placebo gel placement into intrabony defect

Placebo group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

Study Sites (1)

Unknown Facility

Bangalore, Karnataka, 560002, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Dept of Periodontology

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 16, 2016

Record last verified: 2016-09

Locations

IN (1)