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CompletedNCT02738515Updated Apr 14, 2016

Boric Acid in Degree 2 Furcation Defect

A Phase 2/3 interventional study of 0.75 % Boric Acid and placebo in Chronic Periodontitis With Mandibular Degree 2 Furcation Defects, sponsored by Government Dental College and Research Institute, Bangalore. Completed at 1 site in India. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-14.

Sponsored by Government Dental College and Research Institute, Bangalore · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Chronic Periodontitis With Mandibular Degree 2 Furcation Defects
03

In context

Chronic Periodontitis

377 studies on the registry are indexed under Chronic Periodontitis; 21 are open to participants now.

This study's enrollment of 48 is close to the median of 46 across 307 interventional studies indexed under Chronic Periodontitis.

Browse Chronic Periodontitis studies →

Lead sponsor

Government Dental College and Research Institute, Bangalore is the lead sponsor of 38 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Systemic conditions known to affect the periodontal status
  • Medications known to affect the outcomes of periodontal therapy
  • Hematological disorders and insufficient count (\<200,000/mm3)
  • Pregnancy/lactation
  • Smoking and tobacco use in any form
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Group 1

    Scaling and Root Planing (SRP) with 0.75% BORIC ACID GEL for treating furcation defect

    Drug: 0.75 % Boric Acid

  • Placebo comparator
    Group 2

    Scaling and Root Planing (SRP) with PLACEBO GEL for treating furcation defect.

    Drug: placebo

Interventions

  • After Scaling and Root Planing placement of 0.75% Boric Acid gel in Mandibular degree 2 Furcation defect.

  • Drugplacebo

    After Scaling and Root Planing placement of Placebo gel in Mandibular degree 2 Furcation defect.

06

What researchers measure

Primary outcomes

  1. Radiographic bone fill

    assessed in percentage

    Time frame: Baseline to 6 months

Secondary outcomes

  1. probing depth

    measured in mm

    Time frame: 3 and 6 months

  2. Relative vertical attachment leve

    measured in mm

    Time frame: 3 and 6 months

  3. Relative horizontal attachment level

    measured in mm

    Time frame: 3 and 6 months

  4. modified sulcus bleeding index

    0-3 scale

    Time frame: 3 and 6 months

  5. plaque index

    0-3 scale

    Time frame: 3 and 6 months

07

Study locations

1 site
  • Government Dental College and Research Institute
    Bangalore, Karnataka 560002, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02738515
Lead sponsor
Government Dental College and Research Institute, Bangalore
Responsible party
Dr. A R Pradeep (Professor & Head, Department of Periodontology, Government Dental College and Research Institute, Bangalore) — Principal investigator
First posted
Apr 14, 2016
Start date
Jul 2015
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Apr 14, 2016
View the source record on ClinicalTrials.gov ↗

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