Boric Acid in Degree 2 Furcation Defect

Chronic Periodontitis With Mandibular Degree 2 Furcation Defects Clinical Trial

Official title:

Clinical Efficacy of Subgingivally Delivered 0.75% Boric Acid Gel as an Adjunct to Mechanotherapy in Chronic Periodontitis: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738515
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014ZM
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 11, 2016
• Last updated: April 13, 2016
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Chronic Periodontitis With Mandibular Degree 2 Furcation Defects
• Furcation Defects
• Periodontitis

Intervention

Drug:
• 0.75 % Boric Acid
After Scaling and Root Planing placement of 0.75% Boric Acid gel in Mandibular degree 2 Furcation defect.
• placebo
After Scaling and Root Planing placement of Placebo gel in Mandibular degree 2 Furcation defect.

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic bone fill	assessed in percentage	Baseline to 6 months	No
Secondary	probing depth	measured in mm	3 and 6 months	No
Secondary	Relative vertical attachment leve	measured in mm	3 and 6 months	No
Secondary	Relative horizontal attachment level	measured in mm	3 and 6 months	No
Secondary	modified sulcus bleeding index	0-3 scale	3 and 6 months	No
Secondary	plaque index	0-3 scale	3 and 6 months	No