Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903108
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014O
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2016
• Last updated: September 15, 2016
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: September 2016
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• SRP plus boric acid gel
SRP followed by 0.75% boric acid placement into intrabony defect
• SRP plus placebo gel
SRP followed by placebo gel placement into intrabony defect

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defect depth reduction (%)	assessed in percentage	Change from baseline to 6 months	No
Secondary	probing depth (mm)	measured in mm	Change from baseline to 6 months	No
Secondary	clinical attachment level (mm)	measured in mm	Change from baseline to 6 months	No
Secondary	modified sulcus bleeding index	scale from 0-3	Change from baseline to 6 months	No
Secondary	plaque index	scale from 0-3	Change from baseline to 6 months	No