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Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02903108
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Brief Summary:
The purpose of the present study was to evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing in chronic periodontitis (CP) patients.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: SRP plus boric acid gel Drug: SRP plus placebo gel Phase 2 Phase 3

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 with chronic periodontitis (CP) patients.

Methods: Thirty nine 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Boric acid

Arm Intervention/treatment
Active Comparator: Boric acid group
Oral prophylaxis followed by 0.75% boric acid drug in gel form placed in intrabony defects
Drug: SRP plus boric acid gel
SRP followed by 0.75% boric acid placement into intrabony defect

Placebo Comparator: Placebo group
Oral prophylaxis followed by placebo gel placement in intrabony defects
Drug: SRP plus placebo gel
SRP followed by placebo gel placement into intrabony defect




Primary Outcome Measures :
  1. Defect depth reduction (%) [ Time Frame: Change from baseline to 6 months ]
    assessed in percentage


Secondary Outcome Measures :
  1. probing depth (mm) [ Time Frame: Change from baseline to 6 months ]
    measured in mm

  2. clinical attachment level (mm) [ Time Frame: Change from baseline to 6 months ]
    measured in mm

  3. modified sulcus bleeding index [ Time Frame: Change from baseline to 6 months ]
    scale from 0-3

  4. plaque index [ Time Frame: Change from baseline to 6 months ]
    scale from 0-3



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Systemically healthy with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs
  • Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy

Exclusion Criteria:

  • Patients on systemic boron therapy
  • Known or suspected allergy to boron supplementation
  • Patients with aggressive periodontitis
  • Tobacco use in any form, smokers, alcoholics
  • Immunocompromised and systemically unhealthy patients
  • Pregnant or lactating females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903108


Locations
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India
Bangalore, Karnataka, India, 560002
Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore

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Responsible Party: Dr. A R Pradeep, Professor and Head, Dept of Periodontology, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02903108     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014O
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases