Clinical trial NCT03488056: Effectiveness of ICCMS in Reducing the Incidence of Dental Caries in Children
Official title: Effectiveness of the International Caries Classification and Management System (ICCMS) in Reducing the Incidence of Dental Caries in Children Attending to the CURUMIM Social Project, Sesc/São Paulo(SP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: Dental Caries, ICCMS, Risk Assessment
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Serviço Social do Comércio - SESC
First posted: 2018-04-04
Enrollment: 460
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization was made by centers of the SESC (Social Service of the Commerce) of São Paulo state. Four centers will follow the ICCMS criteria and four other centers will follow criteria for diagnosis and treatment of SESC. The randomization will be stratified by sociodemographical conditions. The minimization will be used to equate preexisting oral health-related activities. According to allocated strategy, dentists in the center will guide their conduct with children attended to the CURUMIM project.
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to evaluate the effectiveness of using the ICCMS (International Caries Classification And Management System)in reducing caries lesions incidence compared to a control group that use different criteria as a not systematic and standardized prevention strategy. The study will be performed among children attending to the social project of Social Service of Commerce (SESC), Sao Paulo. The sample will be composed of 460 children aging between 7 to 12 years old registered in CURUMIM Program from eight dental centers of SESC. A randomized controlled study with parallel group will be conducted. The centers will be randomized between the 2 strategies, defining 2 groups with 4 centers each. The experimental group that will follow the criteria defined by the ICCMS will evaluate clinical and behavioral variables, it will define: evaluation of the caries risk of the patient, evaluation of the intraoral risk, diagnosis of the caries lesion and its respective activity, plan decision individualized treatment for the patient and indication of recall interval according to the risk of caries. In the control group, children need will be solved according to rthe routinely dental practices in the center, but the determination of the child's general and intraoral risk of developing new caries lesions will not be performed nor the scheduling of specific recall intervals according to the risk.


Eligibility criteria: Inclusion Criteria:

* Children who participate in the CURUMIM Program
* Children whose parents sign the term of informed consent confirming their participation.

Exclusion Criteria:

* Children with cognitive impairment, motor impairment and feeding tube.

Primary outcomes:
measure: Incidence of caries
timeFrame: 2 years
measure: Cost-effectiveness
timeFrame: 2 years
Secondary outcomes:
measure: New initial caries lesions
timeFrame: 2 years
measure: Qualitative measurement of difficulties and issues during the programs implementation
timeFrame: 2 years
measure: Oral Health-Related Quality of Life (OHRQoL)
timeFrame: 2 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Mariana M Braga
role: PRINCIPAL_INVESTIGATOR
References: