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Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
SRP plus boric acid gel
SRP plus placebo gel
Sponsored by
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Boric acid group

Placebo group

Arm Description

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

Oral prophylaxis followed by placebo gel placement in intrabony defects

Outcomes

Primary Outcome Measures

Defect depth reduction (%)
assessed in percentage

Secondary Outcome Measures

probing depth (mm)
measured in mm
clinical attachment level (mm)
measured in mm
modified sulcus bleeding index
scale from 0-3
plaque index
scale from 0-3

Full Information

First Posted
September 13, 2016
Last Updated
September 15, 2016
Sponsor
Government Dental College and Research Institute, Bangalore
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1. Study Identification

Unique Protocol Identification Number
NCT02903108
Brief Title
Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boric acid group
Arm Type
Active Comparator
Arm Description
Oral prophylaxis followed by 0.75% boric acid drug in gel form placed in intrabony defects
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Oral prophylaxis followed by placebo gel placement in intrabony defects
Intervention Type
Drug
Intervention Name(s)
SRP plus boric acid gel
Intervention Description
SRP followed by 0.75% boric acid placement into intrabony defect
Intervention Type
Drug
Intervention Name(s)
SRP plus placebo gel
Intervention Description
SRP followed by placebo gel placement into intrabony defect
Primary Outcome Measure Information:
Title
Defect depth reduction (%)
Description
assessed in percentage
Time Frame
Change from baseline to 6 months
Secondary Outcome Measure Information:
Title
probing depth (mm)
Description
measured in mm
Time Frame
Change from baseline to 6 months
Title
clinical attachment level (mm)
Description
measured in mm
Time Frame
Change from baseline to 6 months
Title
modified sulcus bleeding index
Description
scale from 0-3
Time Frame
Change from baseline to 6 months
Title
plaque index
Description
scale from 0-3
Time Frame
Change from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India

12. IPD Sharing Statement

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Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis

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