Clinical trial NCT03189797: Effect of Tailored Preventive Program on Caires Incidence Using International Caries Classification and Management System (ICCMS) A Randomized Clinical Trial
Official title: Effect of Tailored Preventive Program on Caires Incidence Using International Caries Classification and Management System (ICCMS) A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total number of 144 high caries risk dental students are selected based on the applied caries risk assessment method (CAMBRA). In the study group they are given a preventive program as homecare program including tooth brushing 2/day with a fluoride toothpaste( 5000 ppm F) in addition to fluoride mouth rinse. For the clinical approach motivational engagement isdone by discussing with patients how to improve oral health behavior including amount of sugar, fibrous food and junk food. This in addition to pits and fissures sealant, F- varnish 2 times /year.application of fluoride varnish every 6 months and dietary intake interventions.

In the Control group participants assigned to the control condition will be advised to maintain their existing lifestyles. For ethical reasons, if the program shows its effectiveness, it will be made available to all groups at the end of the study.
Primary purpose: PREVENTION

Brief summary: This study will be conducted to evaluate The Effect of tailored preventive program on caries incidence using International Caries Classification and Management System (ICCMS) at a follow up periods of 3 ,6 and 12 months.

Detailed description: A total number of 144 high caries risk dental students were selected based on the applied caries risk assessment method (CAMBRA). In the study group they were given a preventive program as homecare program including tooth brushing 2/day with a fluoride toothpaste( 5000 ppm F) following the instructions in addition to fluoride mouth rinse. For the clinical approach motivational engagement was done by discussing with patients how to improve oral health behavior including amount of sugar, fibrous food and junk food. This in addition to pits and fissures sealant, F- varnish 2 times /year. Recalls up were done at 3, 6 and 12 months by recording the caries prevalence , application of fluoride varnish every 6 months and dietary intake interventions. In the Control group participants assigned to the control condition will be advised to maintain their existing lifestyles. For ethical reasons, if the program shows its effectiveness, it will be made available to all groups at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Dental student.
* No malocclusion.
* Medically free

Exclusion Criteria:

* Compromised medical history.
* Severe or active periodontal disease.
* Heavy bruxism or a traumatic occlusion

Primary outcomes:
measure: Incidence of dental caires
timeFrame: baseline
measure: Incidence of dental caires
timeFrame: 3 months
measure: Incidence of dental caires
timeFrame: 6 months
measure: Incidence of dental caires
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mamdouh
state: Maadi
Study officials:
References:
citation: Garcia RI, Sohn W. The paradigm shift to prevention and its relationship to dental education. J Dent Educ. 2012 Jan;76(1):36-45.