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

August 11, 2021 updated by: Katreen Tawfik, Cairo University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of disability like special needs autism and down syndrome

Exclusion Criteria:

  • age below 13

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Comparator
Preventive protocol
Behavioral: Preventive protocol
Preventive protocol
Other Names:
  • Caries preventive protocol
Experimental: Intervention
Adding chlorhexidine to the preventive protocol
Drug: Chlorhexidine varnish added to the preventive protocol
Antibacterial agent varnish added to the preventive protocol
Other Names:
  • Varnish

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Katreen Fouad, Resident

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

July 15, 2021

Study Completion (Actual)

August 11, 2021

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 19, 2020

First Posted (Actual)

December 22, 2020

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7all

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Journal

IPD Sharing Time Frame

10 months

IPD Sharing Access Criteria

Journal article

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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