Boric Acid in Degree 2 Furcation Defect
Clinical Efficacy of Subgingivally Delivered 0.75% Boric Acid Gel as an Adjunct to Mechanotherapy in Chronic Periodontitis: A Randomized Controlled Clinical Trial
1 other identifier
interventional
48
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedApril 14, 2016
April 1, 2016
7 months
April 11, 2016
April 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Radiographic bone fill
assessed in percentage
Baseline to 6 months
Secondary Outcomes (5)
probing depth
3 and 6 months
Relative vertical attachment leve
3 and 6 months
Relative horizontal attachment level
3 and 6 months
modified sulcus bleeding index
3 and 6 months
plaque index
3 and 6 months
Study Arms (2)
Group 1
ACTIVE COMPARATORScaling and Root Planing (SRP) with 0.75% BORIC ACID GEL for treating furcation defect
Group 2
PLACEBO COMPARATORScaling and Root Planing (SRP) with PLACEBO GEL for treating furcation defect.
Interventions
After Scaling and Root Planing placement of 0.75% Boric Acid gel in Mandibular degree 2 Furcation defect.
After Scaling and Root Planing placement of Placebo gel in Mandibular degree 2 Furcation defect.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Government Dental College and Research Institute
Bangalore, Karnataka, 560002, India
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor & Head, Department of Periodontology
Study Record Dates
First Submitted
April 11, 2016
First Posted
April 14, 2016
Study Start
July 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 14, 2016
Record last verified: 2016-04