Chance to Avoid New Caries by Adding Chlorhexidine to the Preventive Protocol in Adolescent Special Needs

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

Chance to Avoid New Caries by Adding Chlorhexidine Containing Chemotherapeutic Agent to the Conventional Preventive Protocol for Patients With Special Needs

Adolescent Special need individuals are most need of easy forms of antibacterial agents, so in this study, using chemotherapeutic agents like the newly introduced varnish containing chlorhexidine seems to be a quite promising tool for local delivery to patients with special needs . Chlorhexidine is a wide spectrum very effective bactericidal used for years against the oral flora while fluorides are well known with their antibacterial ability. This may be an excellent way to reduce the risk assessment in adolescent special needs patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be divided into two groups according to the tested regimen, where (A1) represents participants exposed to risk based conventional protocol, (A2) represents participants exposed to chlorhexidine containing varnish and risk based conventional preventive protocol. The study will be carried over a period of 10 months (one academic year), the study will be divided into three phases Phase I: Information of the Cariogram parameters (caries experience, diet content, diet frequency, plaque amount, mutans streptococci, fluoride program, saliva secretion and saliva buffer capacity) will be collected, which will be used to generate the individual caries profile, based on which the participants will be divided into 2 risks groups. Phase II: Risk based preventive program will be implemented including the restorative part. Phase III: At the end of 10 months, caries profile will be generated again

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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 : autism and down syndrome.
  • Must be able to open his/her mouth for varnish application

Exclusion Criteria:

  • systemically unhealthy patients with fetal diseases
  • Age below 13 and above 18

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: caries preventive protocol
preventive protocol for special needs ( tooth brushing , topical fluoride and mouth wash)
Behavioral: preventive protocol
preventive protocol
Other: chlorhexidine varnish added to the caries preventive protocol
chlorhexidine varnish preventive caries protocol for special needs
Behavioral: chlorhexidine added to the preventive protocol
chlorhexidine varnish added to the preventive protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chance to avoid new caries
Time Frame: 10 months
% of the green sector in the cariogram
10 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: katreen tawfik, master, Cairo U

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)

July 15, 2020

Primary Completion (Actual)

July 15, 2021

Study Completion (Actual)

July 15, 2021

Study Registration Dates

First Submitted

July 18, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (Actual)

July 24, 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

  • abcxyz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

publications in journal

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

online access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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