An interventional study of ICCMS and SESC standard care in Dental Caries, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-04.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
The dentists will perform clinical examination on children following the ICCMS sequence: The patient's caries risk assessment, Diagnosis of caries lesion and activity assessment Intraoral risk assessment, Decide on a personalized care plan for patient and clinical interventions.After asses all the factors and defining the patient's individual risk, the system presents a personalized treatment plan, indicating the appropriate home care instructions, clinical interventions and specific treatment for each caries lesion categories. The return intervals will be scheduled according to the risk: low risk (return of 1 year), moderate risk (6 months) and high risk (3 months)
Other: ICCMS
The clinical sequence in this group will be: Caries Diagnosis Operative and non-operative treatments Indication of recall interval according to the dentist However, dentists will do that without a schematic guide to follow. They will do as they usually do in their practices.
Other: SESC standard care
The patient's caries risk assessment, Diagnosis of caries lesion and activity assessment -Intraoral risk assessment, Decide on a personalized care plan for patient and clinical interventions. After asses all the factors and defining the patient's individual risk, the system presents a personalized treatment plan, indicating the appropriate home care instructions, clinical interventions and specific treatment for each caries lesion categories. The treatment is divided into Non-Operative Care and Tooth-Preserving Operative Care (restorations with minimal intervention to preserve maximum dental structure). The return intervals will be scheduled according to the risk: low risk (return of 1 year), moderate risk (6 months) and high risk (3 months)
Standard care related to: Caries Diagnosis, operative and non-operative treatments, Indication of recall interval according to the dentist opinion
Incidence of caries
New cavitated caries lesions
Time frame: 2 years
Cost-effectiveness
Ratio between the difference in costs and in effects regarding the programs
Time frame: 2 years
New initial caries lesions
New initial caries lesions
Time frame: 2 years
Qualitative measurement of difficulties and issues during the programs implementation
Health professional views about the program implementation (impact) collected periodically by a structured online report followed by an interview
Time frame: 2 years
Oral Health-Related Quality of Life (OHRQoL)
Difference in Oral Health-Related Quality of Life (OHRQoL) scores using the Brazilian validated version of Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire (before and after treatment). Bigger the difference, bigger the impact of the program on children's OHRQoL
Time frame: 2 years
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University of Sao Paulo