"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque... | NCT02154594

Studies
"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.

NCT02154594

Sponsor

Tatyasaheb Kore Dental College

Status

Completed

Last Update Posted

Jun 3, 2014Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Gingivitis

Interventions

Acacia catechu
Chlorhexidine gluconate
Distilled water

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

May 2014

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

Feb 2014

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

May 26, 2014

First Submission Date that Met QC Criteria

May 30, 2014

First Posted Date

Jun 3, 2014Estimated

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

May 30, 2014

Last Update Posted Date

Jun 3, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

DR.DHANASHREE RAVINDRA AGARWAL, POST GRADUATE STUDENT IN PERIODONTOLOGY, Tatyasaheb Kore Dental CollegePrincipal Investigator

Lead Sponsor

Tatyasaheb Kore Dental CollegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To study effect of acacia catechu a herbal extract;as antipaque and antigingivitis agent in patients with fixed orthodontic appliances.This study is a double blind randomized controlled trial.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acacia	Experimental	Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days	Drug: Acacia catechu Drug: Chlorhexidine gluconate Other: Distilled water
Chlorhexidine gluconate	Active Comparator	Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days	Drug: Acacia catechu Drug: Chlorhexidine gluconate Other: Distilled water
Distilled water	Placebo Comparator	Rinse with 10 ml distilled water twice daily for 15 days.	Drug: Acacia catechu Drug: Chlorhexidine gluconate Other: Distilled water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acacia catechu	Drug		Acacia Chlorhexidine gluconate Distilled water
Chlorhexidine gluconate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes from baseline in Plaque index(PI)		15 Days

Secondary Outcomes

Measure	Description	Time Frame
Changes from baseline in Gingival index(GI)		15 Days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

60 patients in the age group of 15-30 yrs
plaque induced gingivitis having fixed orthodontic appliance

Exclusion Criteria:

seeking any type of antibacterial mouthwash within four weeks of commencement of study,
history of any systemic disease, or past illness,
mentally or physically handicapped,
history of smoking, tobacco chewing, alcohol consumption,
patients with periodontitis, pregnant and lactating women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr.Dhanashree R. Agarwal, B.D.S.	Tatyasaheb Kore Dental College and Research Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tatyasaheb Kore Dental College and Research Centre		Kolhāpur	Maharashtra	416 137	India

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C010882	chlorhexidine gluconate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided