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

Disabilities Multiple Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485312
• Other study ID #: abcxyz
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Disabilities Multiple

Intervention

Behavioral:
• preventive protocol
preventive protocol
• chlorhexidine added to the preventive protocol
chlorhexidine varnish added to the preventive protocol

Locations

Country	Name	City	State
Egypt	School	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chance to avoid new caries	% of the green sector in the cariogram	10 months