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Completed

NCT Number: NCT02738515

Boric Acid in Degree 2 Furcation Defect

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).

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.75 % Boric Acid

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Radiographic bone fill

    Time frame: Baseline to 6 months

    assessed in percentage

Secondary outcomes

  1. probing depth

    Time frame: 3 and 6 months

    measured in mm

  2. Relative vertical attachment leve

    Time frame: 3 and 6 months

    measured in mm

  3. Relative horizontal attachment level

    Time frame: 3 and 6 months

    measured in mm

  4. modified sulcus bleeding index

    Time frame: 3 and 6 months

    0-3 scale

  5. plaque index

    Time frame: 3 and 6 months

    0-3 scale

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
2016
Study completion
2016
First posted
Apr 14, 2016
Registry last updated
Apr 14, 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.