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

Cairo University (CU)

Status: Completed

Conditions: Disabilities Multiple

Treatments: Behavioral: chlorhexidine added to the preventive protocol; Behavioral: preventive protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04485312

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Details and patient eligibility

About

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.

Full 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

Enrollment: 22 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups

caries preventive protocol

Active Comparator group

Description:

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

Treatment:

Behavioral: preventive protocol

chlorhexidine varnish added to the caries preventive protocol

Other group

Description:

chlorhexidine varnish preventive caries protocol for special needs

Treatment:

Behavioral: chlorhexidine added to the preventive protocol