Periodontal Disease Treatment of a Physically Challenged... | NCT01718912

Studies
Periodontal Disease Treatment of a Physically Challenged Population

NCT01718912

Sponsor

Oravital Inc

Status

Completed

Last Update Posted

Mar 31, 2016Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

Periodontal Disease

Interventions

metronidazole-nystatin oral rinse

Countries

Canada

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

ID	Type	Description	Link
TRI	Other Identifier	Toronto Rehabilitation Institute

Status Module

Record Verification Date

Mar 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

Nov 2013

Primary Completion Date

Sep 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Oct 29, 2012

First Submission Date that Met QC Criteria

Oct 29, 2012

First Posted Date

Oct 31, 2012Estimated

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

Mar 29, 2016

Last Update Posted Date

Mar 31, 2016Estimated

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

Many physically handicapped patients at the dental department, Toronto Rehabilitation Institute(TRI) have considerable gingival inflammation and breath odour because of the inability to effectively handle a toothbrush. These patients have considerable periodontal disease. There is a concern that these pathogens may have a detrimental effect on wound healing in other areas of the body.

Hypothesis: Patients attending the dental department at TRI that are treated with the antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial decrease in periodontal disease as measured by bleeding points and pocket depth when compared to the group that continues to use their regular oral hygiene methods (control group).

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metronidazole-nystatin oral rinse, regular oral hygiene	Other	Week 1: daily brushing with suction brush. Week two: daily brushing with a mixture of metronidazole-nystatin suspension.	Drug: metronidazole-nystatin oral rinse

Interventions

Name	Type	Description	Arm Group Labels	Other Names
metronidazole-nystatin oral rinse	Drug		Metronidazole-nystatin oral rinse, regular oral hygiene

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evidence of healing of periodontal tissues as shown by a reduction of bleeding	Evidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe.	two weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be between the ages of 18 to 65 years Participants must have at least 6 teeth. Participants must have some indication of gingivitis and periodontal breakdown. -

Exclusion Criteria:

Patients who are taking Warfarin/Coumadin Patients who are allergic to Metronidazole or chlorhexidine. Edentulous patients will be excluded by those who have at least 6 teeth can be a participant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder 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
Toronto Rehabilitation Institute, Dental Department		Toronto	Ontario	M5G 2A2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases
D010514	Periodontal Pocket

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D010518	Periodontitis

Browse Leaves

Not provided

Browse Branches

Not provided