Boric Acid in Degree 2 Furcation Defect

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Periodontitis With Mandibular Degree 2 Furcation Defects

Treatments: Drug: 0.75 % Boric Acid; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02738515

GDCRI/ACM/PG/PhD/2/2013-2014ZM

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 48 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

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

Treatment:

Drug: 0.75 % Boric Acid

Group 2

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo