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Boric Acid in Degree 2 Furcation Defect

Primary Purpose

Chronic Periodontitis With Mandibular Degree 2 Furcation Defects

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
0.75 % Boric Acid
placebo
Sponsored by
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis With Mandibular Degree 2 Furcation Defects

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Government Dental College and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Radiographic bone fill
assessed in percentage

Secondary Outcome Measures

probing depth
measured in mm
Relative vertical attachment leve
measured in mm
Relative horizontal attachment level
measured in mm
modified sulcus bleeding index
0-3 scale
plaque index
0-3 scale

Full Information

First Posted
April 11, 2016
Last Updated
April 13, 2016
Sponsor
Government Dental College and Research Institute, Bangalore
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1. Study Identification

Unique Protocol Identification Number
NCT02738515
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis With Mandibular Degree 2 Furcation Defects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Scaling and Root Planing (SRP) with 0.75% BORIC ACID GEL for treating furcation defect
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Scaling and Root Planing (SRP) with PLACEBO GEL for treating furcation defect.
Intervention Type
Drug
Intervention Name(s)
0.75 % Boric Acid
Intervention Description
After Scaling and Root Planing placement of 0.75% Boric Acid gel in Mandibular degree 2 Furcation defect.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
After Scaling and Root Planing placement of Placebo gel in Mandibular degree 2 Furcation defect.
Primary Outcome Measure Information:
Title
Radiographic bone fill
Description
assessed in percentage
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
probing depth
Description
measured in mm
Time Frame
3 and 6 months
Title
Relative vertical attachment leve
Description
measured in mm
Time Frame
3 and 6 months
Title
Relative horizontal attachment level
Description
measured in mm
Time Frame
3 and 6 months
Title
modified sulcus bleeding index
Description
0-3 scale
Time Frame
3 and 6 months
Title
plaque index
Description
0-3 scale
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Government Dental College and Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India

12. IPD Sharing Statement

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Boric Acid in Degree 2 Furcation Defect

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