Clinical Trial: Boric Acid in Degree 2 Furcation Defect

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Government Dental College and Research Institute, Bangalore

Current Primary Outcome: Radiographic bone fill [ Time Frame: Baseline to 6 months ]

assessed in percentage


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • probing depth [ Time Frame: 3 and 6 months ]
    measured in mm
  • Relative vertical attachment leve [ Time Frame: 3 and 6 months ]
    measured in mm
  • Relative horizontal attachment level [ Time Frame: 3 and 6 months ]
    measured in mm
  • modified sulcus bleeding index [ Time Frame: 3 and 6 months ]
    0-3 scale
  • plaque index [ Time Frame: 3 and 6 months ]
    0-3 scale


Original Secondary Outcome: Same as current

Information By: Government Dental College and Research Institute, Bangalore

Dates:
Date Received: April 11, 2016
Date Started: July 2015
Date Completion:
Last Updated: April 13, 2016
Last Verified: April 2016