Evaluation and Comparison of the Efficacy of Triphala Mou... | NCT01900535

Studies
Evaluation and Comparison of the Efficacy of Triphala Mouthwash and 0.2% Chlorhexidine

NCT01900535

Sponsor

Tatyasaheb Kore Dental College

Status

Completed

Last Update Posted

Jul 16, 2013Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Periodontal Disease

Interventions

Not provided

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

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 2013

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Jul 11, 2013

First Submission Date that Met QC Criteria

Jul 15, 2013

First Posted Date

Jul 16, 2013Estimated

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

Jul 15, 2013

Last Update Posted Date

Jul 16, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to evaluate the usefulness of triphala mouthwash in comparison with the gold standard chlorhexidine in hospitalized and periodontally diseased patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

15 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Measure	Description	Time Frame
plaque index		15 days

Measure	Description	Time Frame
gingival index		15 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age group of 20-65 years having periodontal diseases according to American Academy of Periodontology (AAP) classification 1999

Exclusion Criteria:

patients seeking any periodontal treatment during the course of study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

The participants were selected from patients admitted to three different medical hospitals namely Mahatma Gandhi Hospital, New Pargaon, Sub district Government Hospital, Kodoli and Yeshwant Chavan Hospital, Kodoli

Sampling Method

Probability Sample

Type	Date	Date Unknown
Release	Jul 17, 2013
Reset	Sep 19, 2013
Release	Nov 28, 2013
Reset	Jan 15, 2014

Submission Tracking

Estimated Results First Submitted Date

Jul 17, 2013

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 17, 2013			Sep 19, 2013
Nov 28, 2013

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases
D005891	Gingivitis
D010518	Periodontitis

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D007239	Infections
D005882	Gingival Diseases

Browse Leaves

Not provided

Browse Branches

Not provided