Boric Acid in Degree 2 Furcation Defect | NCT02738515

Studies
Boric Acid in Degree 2 Furcation Defect

NCT02738515

Sponsor

Government Dental College and Research Institute, Bangalore

Status

Completed

Last Update Posted

Apr 14, 2016Estimated

Enrollment

48Actual

Phase

Phase 2Phase 3

Conditions

Chronic Periodontitis With Mandibular Degree 2 Furcation Defects

Interventions

0.75 % Boric Acid
placebo

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Apr 11, 2016

First Submission Date that Met QC Criteria

Apr 13, 2016

First Posted Date

Apr 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2016

Last Update Posted Date

Apr 14, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. A R Pradeep, Professor & Head, Department of Periodontology, Government Dental College and Research Institute, BangalorePrincipal Investigator

Lead Sponsor

Government Dental College and Research Institute, BangaloreOTHER

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	Scaling and Root Planing (SRP) with 0.75% BORIC ACID GEL for treating furcation defect	Drug: 0.75 % Boric Acid
Group 2	Placebo Comparator	Scaling and Root Planing (SRP) with PLACEBO GEL for treating furcation defect.	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.75 % Boric Acid	Drug	After Scaling and Root Planing placement of 0.75% Boric Acid gel in Mandibular degree 2 Furcation defect.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiographic bone fill	assessed in percentage	Baseline to 6 months

Secondary Outcomes

Measure	Description	Time Frame
probing depth	measured in mm	3 and 6 months
Relative vertical attachment leve	measured in mm	3 and 6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Government Dental College and Research Institute		Bangalore	Karnataka	560002	India