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Effectiveness of an ICCMS™ Caries Management Program.

NCT04676230 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-12-19

No results posted yet for this study

Summary

The aim of this study is to compare in schoolchildren the effectiveness of an updated caries management program based on the current caries paradigm with the ICCMS™ system (International Caries Classification and Management System) versus an adjusted Colombian dental public health service caries management program, in terms of: 1- caries risk probability, 2- caries lesions, 3- parents' knowledge, attitudes and practices regarding children's oral health.

Null hypothesis: the caries management program based on its current paradigm offers the same degree of effectiveness than the conventional caries management program.

Alternative hypothesis: the caries management program based on its current paradigm offers a different degree of effectiveness than the conventional caries management program.

Conditions

  • Caries

Interventions

PROCEDURE

Experimental group

Caries management based on the ICCMSTM: Patient intervention according to the caries risk likelihood: high, moderate or low. Surfaces intervention according to the surface diagnosis decision matrix (ICCMSTM): Mi: Initial caries management, Mm: Moderate caries management, and Me: Extensive caries management.

PROCEDURE

Control group

Systematic patient caries risk intervention (all managed as high risk patients). Surfaces intervention with conventional caries management of cavitated/dentin caries lesions (restorative treatment).

Sponsors & Collaborators

  • Universidad El Bosque, Bogotá

    lead OTHER

Principal Investigators

  • Stefania Martignon, PhD · UNICA - Unidad de Investigación en Caries, Facultad de Odontología

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-11-30
Completion
2019-05-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676230 on ClinicalTrials.gov