Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: SRP plus boric acid gel
* Drug: SRP plus placebo gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Boric acid group<br>Oral prophylaxis followed by 0.75% boric acid drug in gel form placed in intrabony defects | Drug: SRP plus boric acid gel<br>* SRP followed by 0.75% boric acid placement into intrabony defect<br>|
| Placebo Comparator: Placebo group<br>Oral prophylaxis followed by placebo gel placement in intrabony defects | Drug: SRP plus placebo gel<br>* SRP followed by placebo gel placement into intrabony defect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defect depth reduction (%) | assessed in percentage | Change from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing depth (mm) | measured in mm | Change from baseline to 6 months | 
| clinical attachment level (mm) | measured in mm | Change from baseline to 6 months | 
| modified sulcus bleeding index | scale from 0-3 | Change from baseline to 6 months | 
| plaque index | scale from 0-3 | Change from baseline to 6 months |