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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.
Full description
This study counts with ethical approval from the Ethics Board in Universidad El Bosque (UEB 008-2014).
Population:
The study population will be 6-7 year-old schoolchildren from the six participant dental schools.
Baseline examination:
The baseline examination will be conducted by the site coordinator examiner. Once the informed consent is signed by the parents and the children give their acceptance, a comprehensive examination will be performed, including:
Parents' knowledge, attitudes and practices survey regarding children's oral health.
Caries risk probability assessment through individual caries risk assessment plus patient current caries status: low, moderate, high.
Radiographic caries detection using the ICCMS™ criteria.
Clinical examination:
Progression assessment of present caries lesions using ICCMS™ criteria in terms of Active or Inactive.
Synthesis and analysis:
The synthesis and analysis of the gathered information will conduce to the ICCMS™ caries management decision plan in terms of caries risk likelihood management and caries lesions management with a structure conservative approach.
This study counts with ethical approval from the Ethics Board in Universidad El Bosque (UEB 008-2014).
Population:
The study population will be 6-7 year-old schoolchildren from the six participant dental schools.
Baseline examination:
The baseline examination will be conducted by the site coordinator examiner. Once the informed consent is signed by the parents and the children give their acceptance, a comprehensive examination will be performed, including:
Parents' knowledge, attitudes and practices survey regarding children's oral health.
Caries risk probability assessment through individual caries risk assessment plus patient current caries status: low, moderate, high.
Radiographic caries detection using the ICCMS™ criteria.
Clinical examination:
Progression assessment of present caries lesions using ICCMS™ criteria in terms of Active or Inactive.
Synthesis and analysis:
The synthesis and analysis of the gathered information will conduce to the ICCMS™ caries management decision plan in terms of caries risk likelihood management and caries lesions management with a structure conservative approach.
The first step of the management plan considers the caries risk likelihood.
The management options include:
The patient's caries risk factors management plan is tailored at the individual level and involves actions to protect sound tooth surfaces from developing new caries lesions, and all current active and inactive lesions from progressing. In addition, it aims at lowering the caries risk likelihood of the patient when moderate or high, and to maintain it if low.
The second step is the caries diagnosis decision making at the surface level which conducts to the surface diagnosis decision matrix. This decision relies on the clinical classification of dental caries using ICCMS™ criteria and the radiographic extent of the lesion (enamel or dentin) plus the activity status of the lesions. Only active caries lesions require caries management. The level of intervention depends on the clinical caries classification of the surface or tooth and the radiological extent (when information is available) of the lesion in enamel or dentin. Management levels of active caries lesions are classified as follows:
For sound surfaces, risk based prevention is performed. For inactive lesions, restorations might be performed depending on esthetic and plaque retention reasons.
Intervention:
The children will be randomized in two groups as follows:
Group A (Experimental): ICCMS™ caries management according to the surface diagnosis decision matrix of active Ci, Cm3/4, and Ce caries lesions. Individual management according to the future patient caries risk likelihood with specific prevention strategies.
Group B (Control): conventional caries management. Operative treatment of Cm and Ce caries lesions (caries shadows and cavities) with conventional restorative treatment. Systematic caries risk management with twice-a-year fluoride gel application, sealants on all occlusal surfaces and oral health literacy.
When the management plan is finalized in both groups, patients must continue attending the clinic according to their group for the following three years.
Follow-up assessments will be conducted at one and three years after baseline, with the baseline indicators as described above.
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240 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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