CariesNCT04676230
Effectiveness of an ICCMS™ Caries Management Program.
A study testing Experimental group in people with Caries, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Experimental group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2014to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from 6 to 7 years old
- Informed consent signed
- Children in standard good general health
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an ICCMS™ Caries Management Program. A Schoolchildren Multicenter Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Caries
- Being tested
- Experimental group, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupProcedure or surgery
Also called ICCMS™ 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.
Control groupProcedure or surgery
Also called Colombian Health System
Systematic patient caries risk intervention (all managed as high risk patients). Surfaces intervention with conventional caries management of cavitated/dentin caries lesions (restorative treatment).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of ICCMSTM caries likelihood after 1 and 3 years.
Change in ICCMSTM caries likelihood subjects' distribution after 1 and 3 years
Measured: up to 36 months
Secondary outcomes (3)
Presence of new caries lesions in terms of ICCMSTM categories after 1 and 3 years.
Change in the presence of new caries lesions in terms of ICCMSTM categories after 1 and 3 years.
Measured: up to 36 months
Number of appointments after 1 and 3 years.
Total number of appointments after1 and 3 years.
Measured: up to 36 months
Progression of existing caries lesion in terms of ICCMSTM categories after 1 and 3 years.
Change in the progression of existing caries lesion in terms of ICCMSTM categories after 1 and 3 years.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study startMar 2014
- Primary completionNov 2017
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to two groups in parallel for the duration of the study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad El Bosque, Bogotá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania Martignon, Universidad El Bosque, Bogotá
- Investigators
- Stefania Martignon, PhD, Principal investigator, UNICA - Unidad de Investigación en Caries, Facultad de Odontología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676230
- Sponsor's protocol ID
- 008-2014
- Status last verified
- Dec 2020
- First submitted
- 10 May 2019
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an ICCMS™ Caries Management Program. A Schoolchildren Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04676230
- Acronym / sponsor ID
- 008-2014
- Conditions
- Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Universidad El Bosque, BogotáUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Experimental groupcaries 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. |
| Control group | Active comparator | Procedure: Control groupSystematic patient caries risk intervention (all managed as high risk patients). Surfaces intervention with conventional caries management of cavitated/dentin caries lesions (restorative treatment). |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children from 6 to 7 years old
- Informed consent signed
- Children in standard good general health
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupAlso: ICCMS™ groupCaries 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 or surgery | Experimental group |
| Control groupAlso: Colombian Health SystemSystematic patient caries risk intervention (all managed as high risk patients). Surfaces intervention with conventional caries management of cavitated/dentin caries lesions (restorative treatment). | Procedure or surgery | Control group |
Primary outcome
Evolution of ICCMSTM caries likelihood after 1 and 3 years.
Time frame: up to 36 months
Change in ICCMSTM caries likelihood subjects' distribution after 1 and 3 years
3 secondary outcomes
Presence of new caries lesions in terms of ICCMSTM categories after 1 and 3 years.
Time frame: up to 36 months
Number of appointments after 1 and 3 years.
Time frame: up to 36 months
Progression of existing caries lesion in terms of ICCMSTM categories after 1 and 3 years.
Time frame: up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefania Martignon, PhD principal investigator
UNICA - Unidad de Investigación en Caries, Facultad de Odontología
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Caries, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of ICCMSTM caries likelihood after 1 and 3 years. (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.