Bangalore, Karnataka, 560002, India
NCT Number: NCT02903108
Clinical Efficacy of 0.75% Boric Acid Gel in Chronic Periodontitis
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
25 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
SRP plus boric acid gel
DrugSRP followed by 0.75% boric acid placement into intrabony defect
SRP plus placebo gel
DrugSRP followed by placebo gel placement into intrabony defect
Primary outcomes
-
Defect depth reduction (%)
Time frame: Change from baseline to 6 months
assessed in percentage
Secondary outcomes
-
probing depth (mm)
Time frame: Change from baseline to 6 months
measured in mm
-
clinical attachment level (mm)
Time frame: Change from baseline to 6 months
measured in mm
-
modified sulcus bleeding index
Time frame: Change from baseline to 6 months
scale from 0-3
-
plaque index
Time frame: Change from baseline to 6 months
scale from 0-3
Sponsors and collaborators
Lead sponsor
Government Dental College and Research Institute, Bangalore
Other
Registry information
Official study title
Clinical Efficacy of Subgingivally Delivered 0.75% Boric Acid Gel As An Adjunct to Mechanotherapy in Chronic Periodontitis: A Randomized Controlled Clinical Trial
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Sep 16, 2016
- Registry last updated
- Sep 16, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Study on Treatment Results and Bone Changes After Replanting Severely Affected Teeth - A Before-and-After Study.
NCT06893107
Chronic Disease, Chronic Periodontitis
Fujairah, Emirate of Fujairah, United Arab Emirates
View Trial DetailsComparison of Clinical and Radiographic Parameters in the Application of Cross-linked Hyaluronic Acid 1.8% and Enamel Matrix Derivative in Periodontal Regeneration.
NCT04274244
Alveolar Bone Loss, Bone Diseases
Valencia, Spain
View Trial DetailsImpact of Periodontitis Grading on Peri-Implant Clinical and Bone Health: A 60-Month Prospective Study
NCT07671456
Aggressive Periodontitis, Chronic Disease
View Trial DetailsUse of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection.
NCT03863249
Alveolar Bone Loss, Bone Diseases
Valencia, Spain
View Trial Details