Effectiveness of an ICCMS™ Caries Management Program.

NCT04676230 | Completed

• 1 other identifier: 008-2014
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Evolution of ICCMSTM caries likelihood after 1 and 3 years.

  Change in ICCMSTM caries likelihood subjects' distribution after 1 and 3 years

  up to 36 months

Secondary Outcomes (3)

• Presence of new caries lesions in terms of ICCMSTM categories after 1 and 3 years.

  up to 36 months

• Number of appointments after 1 and 3 years.

  up to 36 months

• Progression of existing caries lesion in terms of ICCMSTM categories after 1 and 3 years.

  up to 36 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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: Experimental group

Control group

ACTIVE COMPARATOR

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

Procedure: Control group

Interventions

Experimental group PROCEDURE

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.

Also known as: ICCMS™ group

Experimental group

Control group PROCEDURE

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

Also known as: Colombian Health System

Control group

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children from 6 to 7 years old
• Informed consent signed
• Children in standard good general health

You may not qualify if:

• Children with physical disability and/or cognitive diseases
• Children whose family will is planning to move from the city in the following 36 months
• Children with orthopedic/orthodontic appliances at baseline

Sponsors & Collaborators

• Universidad El Bosque, Bogotá: lead

Study Sites (1)

Universidad El Bosque

Bogotá, D.C:, 11001, Colombia

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Stefania Martignon, PhD

  UNICA - Unidad de Investigación en Caries, Facultad de Odontología

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: December 19, 2020
• Study Start: March 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: May 1, 2019
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

CO (1)