Effectiveness of an ICCMS™ Caries Management Program.
Condition: Caries
Study type: Interventional

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.
    

Detailed 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:

             -  dmf/DMF T/S

             -  PUFA Index

             -  Dental surface restoration conditions

             -  ICCMS™ caries visual detection: Cs: Sound Surfaces (ICDAS code 0); Ci:
                Initial-stage caries lesion (ICDAS codes 1 y 2); Cm3/Cm4: Moderate-stage caries
                lesion (ICDAS codes 3-microcavity y 4-dentin shadow) and Ce: Extensive-stage caries
                lesion (ICDAS codes 5 y 6)

        -  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:

             -  dmf/DMF T/S

             -  PUFA Index

             -  Dental surface restoration conditions

             -  ICCMS™ caries visual detection: Cs: Sound Surfaces (ICDAS code 0); Ci:
                Initial-stage caries lesion (ICDAS codes 1 y 2); Cm3/Cm4: Moderate-stage caries
                lesion (ICDAS codes 3-microcavity y 4-dentin shadow) and Ce: Extensive-stage caries
                lesion (ICDAS codes 5 y 6)

        -  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:

        -  Low likelihood: Tooth brushing 2/day with a fluoride toothpaste (≥1,000 ppm F-),
           following the dental team instructions; motivational engagement (discuss with patients
           how to improve oral health behaviors - including amount of sugar); cross-brushing for
           erupting first molars; use of dental floss; recalls every 6 months, including
           professional cleaning.

        -  Moderate likelihood: Previous activities plus prescribed F- mouthrinse; sealants in
           caries risk surfaces, F- varnish 2 times/year; motivational interviewing; recalls every
           3 months, including professional cleaning.

        -  High likelihood: Previous activities and increase F- varnish to 4 times/year plus
           Topical F- application; counseling: reduce sugar amount & frequency; recalls every 3
           months, including professional cleaning.

      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:

        -  MInitial: Initial caries management stage (non-operative care (NOC)-control)

        -  MModerate: Moderate caries management stage (minimally invasive surgical caries
           management with no or minimal dentin removal)

        -  MExtensive: Extensive caries management stage (invasive surgical caries management with
           dentin removal).

      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.
    

Intervention name(s): Experimental group; Control group
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; Systematic patient caries risk intervention (all managed as high risk patients). Surfaces intervention with conventional caries management of cavitated/dentin caries lesions (restorative treatment).
Other intervention name(s): ICCMS™ group; Colombian Health System
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to two groups in parallel for the duration of the study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment