Boric Acid in Degree 2 Furcation Defect

Study Overview
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Brief Summary
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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 patients with chronic periodontitis (CP).

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 patients with chronic periodontitis (CP). Methods:FORTY EIGHT 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 With Mandibular Degree 2 Furcation Defects

Intervention / Treatment
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* Drug: 0.75 % Boric Acid
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of buccal Class II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP) No history of antibiotic or periodontal therapy in the preceding 6 months Exclusion Criteria: Systemic conditions known to affect the periodontal status Medications known to affect the outcomes of periodontal therapy Hematological disorders and insufficient platelet count (<200,000/mm3) Pregnancy/lactation Smoking and tobacco use in any form Immunocompromised individuals Those having unacceptable oral hygiene (plaque index [PI] >1.5) Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II Aggressive periodontitis

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 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: Group 1<br>Scaling and Root Planing (SRP) with 0.75% BORIC ACID GEL for treating furcation defect | Drug: 0.75 % Boric Acid<br>* After Scaling and Root Planing placement of 0.75% Boric Acid gel in Mandibular degree 2 Furcation defect.<br>|
| Placebo Comparator: Group 2<br>Scaling and Root Planing (SRP) with PLACEBO GEL for treating furcation defect. | Drug: placebo<br>* After Scaling and Root Planing placement of Placebo gel in Mandibular degree 2 Furcation defect.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic bone fill | assessed in percentage | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing depth | measured in mm | 3 and 6 months | 
| Relative vertical attachment leve | measured in mm | 3 and 6 months | 
| Relative horizontal attachment level | measured in mm | 3 and 6 months | 
| modified sulcus bleeding index | 0-3 scale | 3 and 6 months | 
| plaque index | 0-3 scale | 3 and 6 months |