Clinical trial NCT02738515: Boric Acid in Degree 2 Furcation Defect
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis With Mandibular Degree 2 Furcation Defects
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiographic bone fill
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: probing depth
timeFrame: 3 and 6 months
measure: Relative vertical attachment leve
timeFrame: 3 and 6 months
measure: Relative horizontal attachment level
timeFrame: 3 and 6 months
measure: modified sulcus bleeding index
timeFrame: 3 and 6 months
measure: plaque index
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Government Dental College and Research Institute
state: Karnataka
Study officials:
References: