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

NCT ID: NCT04485312

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2021-07-15

Brief 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.

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

Conditions

Disabilities Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

caries preventive protocol

preventive protocol for special needs ( tooth brushing , topical fluoride and mouth wash)

Group Type: ACTIVE_COMPARATOR

preventive protocol

Intervention Type: BEHAVIORAL

preventive protocol

chlorhexidine varnish added to the caries preventive protocol

chlorhexidine varnish preventive caries protocol for special needs

Group Type: OTHER

chlorhexidine added to the preventive protocol

Intervention Type: BEHAVIORAL

chlorhexidine varnish added to the preventive protocol

Interventions

preventive protocol

preventive protocol

Intervention Type: BEHAVIORAL

chlorhexidine added to the preventive protocol

chlorhexidine varnish added to the preventive protocol

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Katreen Tawfik

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

katreen tawfik, master

Role: PRINCIPAL_INVESTIGATOR

cairo U

Locations

School

Giza, , Egypt

Countries

Egypt

Other Identifiers

abcxyz

Identifier Type: -

Identifier Source: org_study_id