Boric Acid in Degree 2 Furcation Defect

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-02-29

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).

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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.

Conditions

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Chronic Periodontitis With Mandibular Degree 2 Furcation Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Scaling and Root Planing (SRP) with 0.75% BORIC ACID GEL for treating furcation defect

Group Type ACTIVE_COMPARATOR

0.75 % Boric Acid

Intervention Type DRUG

After Scaling and Root Planing placement of 0.75% Boric Acid gel in Mandibular degree 2 Furcation defect.

Group 2

Scaling and Root Planing (SRP) with PLACEBO GEL for treating furcation defect.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

After Scaling and Root Planing placement of Placebo gel in Mandibular degree 2 Furcation defect.

Interventions

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0.75 % Boric Acid

After Scaling and Root Planing placement of 0.75% Boric Acid gel in Mandibular degree 2 Furcation defect.

Intervention Type DRUG

placebo

After Scaling and Root Planing placement of Placebo gel in Mandibular degree 2 Furcation defect.

Intervention Type DRUG

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes