Antibacterial Effect of Chlorhexidine Added to the Preven... | NCT04679558

Studies
Antibacterial Effect of Chlorhexidine Added to the Preventive Protocol in Adolescent Special Needs

NCT04679558

Sponsor

Cairo University

Status

Completed

Last Update Posted

Aug 13, 2021Actual

Enrollment

22Actual

Phase

Early Phase 1

Conditions

Caries

Interventions

Chlorhexidine varnish added to the preventive protocol
Preventive protocol

Countries

Egypt

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

Aug 2021

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

Sep 15, 2020Actual

Primary Completion Date

Jul 15, 2021Actual

Completion Date

Aug 11, 2021Actual

First Submitted Date

Dec 14, 2020

First Submission Date that Met QC Criteria

Dec 19, 2020

First Posted Date

Dec 22, 2020Actual

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

Aug 11, 2021

Last Update Posted Date

Aug 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly

Detailed Description

This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly cause those have alot of problems concerning the accumulagio. Of plaque and so increased bacteria

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Comparator	Active Comparator	Preventive protocol	Behavioral: Preventive protocol
Intervention	Experimental	Adding chlorhexidine to the preventive protocol	Drug: Chlorhexidine varnish added to the preventive protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chlorhexidine varnish added to the preventive protocol	Drug	Antibacterial agent varnish added to the preventive protocol	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Streptococcus mutans count	Antibacterial effect of chlorhexidine on streptococcus mutans count	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of disability like special needs autism and down syndrome

Exclusion Criteria:

age below 13

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Katreen Fouad	Resident	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Journal

Types

Study Protocol

Time Frame

10 months

Access Criteria

Journal article

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010150	Paint

Ancestor Terms

ID	Term
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided