Effectiveness of ICCMS in Reducing the Incidence of Dental Caries in Children

Dental Caries Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03488056
• Other study ID #: CURUMIM
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2018
• Last updated: April 3, 2018
• Start date: November 16, 2017
• Est. completion date: December 2021

Study information

• Verified date: April 2018
• Source: University of Sao Paulo
• Contact: Mariana M Braga, PhD
• Phone: 551130917835
• Email: mmbraga[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• ICCMS
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)
• SESC standard care
Standard care related to: Caries Diagnosis, operative and non-operative treatments, Indication of recall interval according to the dentist opinion

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Serviço Social do Comércio - SESC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of caries	New cavitated caries lesions	2 years
Primary	Cost-effectiveness	Ratio between the difference in costs and in effects regarding the programs	2 years
Secondary	New initial caries lesions	New initial caries lesions	2 years
Secondary	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	2 years
Secondary	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	2 years