Boric Acid in Degree 2 Furcation Defect

Phase 2

Completed

• Conditions: Chronic Periodontitis With Mandibular Degree 2 Furcation Defects
• Interventions: Drug: placebo; Drug: 0.75 % Boric Acid

• Registration Number: NCT02738515
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-13
• Last Update Submitted: 2016-04-13
• Study First Posted: 2016-04-14
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	placebo	Scaling and Root Planing (SRP) with PLACEBO GEL for treating furcation defect.
Group 1	0.75 % Boric Acid	Scaling and Root Planing (SRP) with 0.75% BORIC ACID GEL for treating furcation defect

Primary Outcome Measures

Name	Time	Method
Radiographic bone fill	Baseline to 6 months	assessed in percentage

Secondary Outcome Measures

Name	Time	Method
modified sulcus bleeding index	3 and 6 months	0-3 scale
probing depth	3 and 6 months	measured in mm
Relative vertical attachment leve	3 and 6 months	measured in mm
Relative horizontal attachment level	3 and 6 months	measured in mm
plaque index	3 and 6 months	0-3 scale

Trial Locations

Locations (1)

Government Dental College and Research Institute; 🇮🇳 Bangalore, Karnataka, India