Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03488056
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
Serviço Social do Comércio - SESC
Information provided by (Responsible Party):
Mariana Minatel Braga, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Dental Caries Other: ICCMS Other: SESC standard care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

The division of the control and experimental groups was done by center and for neither group are revealed to the patient nor responsible for the type of intervention they are undergoing.

After a certain time of the study, a blind investor will examine the children's centers and evaluate the outcome of the study. This researcher will not know which center is a control or experimental group.

Primary Purpose: Prevention
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)
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: Test - ICCMS

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 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)


Active Comparator: Control - Standard care SESC

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
Standard care related to: Caries Diagnosis, operative and non-operative treatments, Indication of recall interval according to the dentist opinion




Primary Outcome Measures :
  1. Incidence of caries [ Time Frame: 2 years ]
    New cavitated caries lesions

  2. Cost-effectiveness [ Time Frame: 2 years ]
    Ratio between the difference in costs and in effects regarding the programs


Secondary Outcome Measures :
  1. New initial caries lesions [ Time Frame: 2 years ]
    New initial caries lesions

  2. Qualitative measurement of difficulties and issues during the programs implementation [ Time Frame: 2 years ]
    Health professional views about the program implementation (impact) collected periodically by a structured online report followed by an interview

  3. Oral Health-Related Quality of Life (OHRQoL) [ Time Frame: 2 years ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488056


Contacts
Layout table for location contacts
Contact: Mariana M Braga, PhD 551130917835 mmbraga@usp.br
Contact: Gabriela S Oliveira 5511961269255 gabriela.sa.oliveira@usp.br

Locations
Layout table for location information
Brazil
University of São Paulo Recruiting
São Paulo, Brazil
Contact: Mariana M Braga         
Sponsors and Collaborators
University of Sao Paulo
Serviço Social do Comércio - SESC
Investigators
Layout table for investigator information
Principal Investigator: Mariana M Braga University of São Paulo

Layout table for additonal information
Responsible Party: Mariana Minatel Braga, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03488056     History of Changes
Other Study ID Numbers: CURUMIM
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mariana Minatel Braga, University of Sao Paulo:
Dental Caries, ICCMS, Risk Assessment
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases