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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04485312
Enrollment
22
Registered
2020-07-24
Start date
2020-07-15
Completion date
2021-07-15
Last updated
2021-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disabilities Multiple

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

Interventions

preventive protocol

BEHAVIORALchlorhexidine added to the preventive protocol

chlorhexidine varnish added to the preventive protocol

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
chance to avoid new caries10 months% of the green sector in the cariogram

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026