Dental CariesNCT03488056
Effectiveness of ICCMS in Reducing the Incidence of Dental Caries in Children
A study testing ICCMS in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of the present study is to evaluate the effectiveness of using the ICCMS (International Caries Classification And Management System)in reducing caries lesions incidence compared to a control group that use different criteria as a not systematic and standardized prevention strategy. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- ICCMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Nov 2017to Dec 2021
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who participate in the CURUMIM Program
- Children whose parents sign the term of informed consent confirming their participation.
Who cannot join
- Children with cognitive impairment, motor impairment and feeding tube.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo
São Paulo
Mariana M Braga
About this study
Official title: Effectiveness of the International Caries Classification and Management System (ICCMS) in Reducing the Incidence of Dental Caries in Children Attending to the CURUMIM Social Project, Sesc/São Paulo(SP)
The aim of the present study is to evaluate the effectiveness of using the ICCMS (International Caries Classification And Management System)in reducing caries lesions incidence compared to a control group that use different criteria as a not systematic and standardized prevention strategy. The study will be performed among children attending to the social project of Social Service of Commerce (SESC), Sao Paulo. The sample will be composed of 460 children aging between 7 to 12 years old registered in CURUMIM Program from eight dental centers of SESC. A randomized controlled study with parallel group will be conducted. The centers will be randomized between the 2 strategies, defining 2 groups with 4 centers each. The experimental group that will follow the criteria defined by the ICCMS will evaluate clinical and behavioral variables, it will define: evaluation of the caries risk of the patient, evaluation of the intraoral risk, diagnosis of the caries lesion and its respective activity, plan decision individualized treatment for the patient and indication of recall interval according to the risk of caries. In the control group, children need will be solved according to rthe routinely dental practices in the center, but the determination of the child's general and intraoral risk of developing new caries lesions will not be performed nor the scheduling of specific recall intervals according to the risk.
- Conditions
- Dental Caries
- Being tested
- ICCMS, SESC standard care
- Keywords
- Dental Caries, ICCMS, Risk Assessment
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICCMSOther
The patient's caries risk assessment, Diagnosis of caries lesion and activity assessment
-Intraoral risk assessment, Decide on a personalized care plan for patient and clinical interventions.
After asses all the factors and defining the patient's individual risk, the system presents a personalized treatment plan, indicating the appropriate home care instructions, clinical interventions and specific treatment for each caries lesion categories.
The treatment is divided into Non-Operative Care and Tooth-Preserving Operative Care (restorations with minimal intervention to preserve maximum dental structure).
The return intervals will be scheduled according to the risk: low risk (return of 1 year), moderate risk (6 months) and high risk (3 months)
SESC standard careOther
Standard care related to: Caries Diagnosis, operative and non-operative treatments, Indication of recall interval according to the dentist opinion
| Study group | Role | What they receive |
|---|---|---|
| Test - ICCMS | Experimental | The dentists will perform clinical examination on children following the ICCMS sequence:
The patient's caries risk assessment, Diagnosis of caries lesion and activity assessment Intraoral risk assessment, Decide on a personalized care plan for patient and clinical interventions.After asses all the factors and defining the patient's individual risk, the system presents a personalized treatment plan, indicating the appropriate home care instructions, clinical interventions and specific treatment for each caries lesion categories.
The return intervals will be scheduled according to the risk: low risk (return of 1 year), moderate risk (6 months) and high risk (3 months) Receives: Other: ICCMS |
| Control - Standard care SESC | Active comparator | The clinical sequence in this group will be:
Caries Diagnosis Operative and non-operative treatments Indication of recall interval according to the dentist However, dentists will do that without a schematic guide to follow. They will do as they usually do in their practices. Receives: Other: SESC standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of caries
New cavitated caries lesions
Measured: 2 years
Cost-effectiveness
Ratio between the difference in costs and in effects regarding the programs
Measured: 2 years
Secondary outcomes (3)
New initial caries lesions
New initial caries lesions
Measured: 2 years
Qualitative measurement of difficulties and issues during the programs implementation
Health professional views about the program implementation (impact) collected periodically by a structured online report followed by an interview
Measured: 2 years
Oral Health-Related Quality of Life (OHRQoL)
Difference in Oral Health-Related Quality of Life (OHRQoL) scores using the Brazilian validated version of Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire (before and after treatment). Bigger the difference, bigger the impact of the program on children's OHRQoL
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start16 Nov 2017
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization was made by centers of the SESC (Social Service of the Commerce) of São Paulo state. Four centers will follow the ICCMS criteria and four other centers will follow criteria for diagnosis and treatment of SESC. The randomization will be stratified by sociodemographical conditions. The minimization will be used to equate preexisting oral health-related activities. According to allocated strategy, dentists in the center will guide their conduct with children attended to the CURUMIM project.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Serviço Social do Comércio - SESC
- Responsible party
- Principal investigator, Mariana Minatel Braga, University of Sao Paulo
- Investigators
- Mariana M Braga, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488056
- Sponsor's protocol ID
- CURUMIM
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2018
- Last updated
- 4 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the International Caries Classification and Management System (ICCMS) in Reducing the Incidence of Dental Caries in Children Attending to the CURUMIM Social Project, Sesc/São Paulo(SP)
- ClinicalTrials.gov ID
- NCT03488056
- Acronym / sponsor ID
- CURUMIM
- Conditions
- Dental Caries
- Keywords
- Dental Caries, ICCMS, Risk Assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Serviço Social do Comércio - SESC
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Apr 2018 (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 the present study is to evaluate the effectiveness of using the ICCMS (International Caries Classification And Management System)in reducing caries lesions incidence compared to a control group that use different criteria as a not systematic and standardized prevention strategy. The study will be performed among children attending to the social project of Social Service of Commerce (SESC), Sao Paulo. The sample will be composed of 460 children aging between 7 to 12 years old registered in CURUMIM Program from eight dental centers of SESC. A randomized controlled study with parallel group will be conducted. The centers will be randomized between the 2 strategies, defining 2 groups with 4 centers each. The experimental group that will follow the criteria defined by the ICCMS will evaluate clinical and behavioral variables, it will define: evaluation of the caries risk of the patient, evaluation of the intraoral risk, diagnosis of the caries lesion and its respective activity, plan decision individualized treatment for the patient and indication of recall interval according to the risk of caries. In the control group, children need will be solved according to rthe routinely dental practices in the center, but the determination of the child's general and intraoral risk of developing new caries lesions will not be performed nor the scheduling of specific recall intervals according to the risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The randomization was made by centers of the SESC (Social Service of the Commerce) of São Paulo state. Four centers will follow the ICCMS criteria and four other centers will follow criteria for diagnosis and treatment of SESC. The randomization will be stratified by sociodemographical conditions. The minimization will be used to equate preexisting oral health-related activities. According to allocated strategy, dentists in the center will guide their conduct with children attended to the CURUMIM project.
| Arm | Type | Receives |
|---|---|---|
| Test - ICCMS | Experimental | Other: ICCMSThe dentists will perform clinical examination on children following the ICCMS sequence: The patient's caries risk assessment, Diagnosis of caries lesion and activity assessment Intraoral risk assessment, Decide on a personalized care plan for patient and clinical interventions.After asses all the factors and defining the patient's individual risk, the system presents a personalized treatment plan, indicating the appropriate home care instructions, clinical interventions and specific treatment for each caries lesion categories. The return intervals will be scheduled according to the risk: low risk (return of 1 year), moderate risk (6 months) and high risk (3 months) |
| Control - Standard care SESC | Active comparator | Other: SESC standard careThe clinical sequence in this group will be: Caries Diagnosis Operative and non-operative treatments Indication of recall interval according to the dentist However, dentists will do that without a schematic guide to follow. They will do as they usually do in their practices. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children who participate in the CURUMIM Program
- Children whose parents sign the term of informed consent confirming their participation.
Key exclusion criteria (1 listed)
- Children with cognitive impairment, motor impairment and feeding tube.
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 |
|---|---|---|
| ICCMSThe patient's caries risk assessment, Diagnosis of caries lesion and activity assessment -Intraoral risk assessment, Decide on a personalized care plan for patient and clinical interventions. After asses all the factors and defining the patient's individual risk, the system presents a personalized treatment plan, indicating the appropriate home care instructions, clinical interventions and specific treatment for each caries lesion categories. The treatment is divided into Non-Operative Care and Tooth-Preserving Operative Care (restorations with minimal intervention to preserve maximum dental structure). The return intervals will be scheduled according to the risk: low risk (return of 1 year), moderate risk (6 months) and high risk (3 months) | Other | Test - ICCMS |
| SESC standard careStandard care related to: Caries Diagnosis, operative and non-operative treatments, Indication of recall interval according to the dentist opinion | Other | Control - Standard care SESC |
Primary outcome
Incidence of caries
Time frame: 2 years
New cavitated caries lesions
Cost-effectiveness
Time frame: 2 years
Ratio between the difference in costs and in effects regarding the programs
3 secondary outcomes
New initial caries lesions
Time frame: 2 years
Qualitative measurement of difficulties and issues during the programs implementation
Time frame: 2 years
Oral Health-Related Quality of Life (OHRQoL)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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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.
Mariana M Braga principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICCMS in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Apr 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariana M Braga, PhD (551130917835, mmbraga@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of caries (time frame: 2 years). The study lists 2 primary outcomes in all. 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 4 Apr 2018.