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Completed

NCT Number: NCT04485312

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

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Key information

Conditions

Disabilities Multiple

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School

Giza, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preventive protocol

Behavioral

preventive protocol

chlorhexidine added to the preventive protocol

Behavioral

chlorhexidine varnish added to the preventive protocol

Primary outcomes

  1. chance to avoid new caries

    Time frame: 10 months

    % of the green sector in the cariogram

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2020
Registry last updated
Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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