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
About this trial
This is an interventional treatment trial for Chronic Periodontitis
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
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
NCT ID
NCT02903108
First Posted
September 13, 2016
Last Updated
September 15, 2016
Sponsor
Government Dental College and Research Institute, Bangalore
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
Learn more about this trial
Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis
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