Condition or disease | Intervention/treatment | Phase |
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Caries,Dental | Diagnostic Test: ICCMS | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | CARies DEtection in Children-Pelotas (CARDEC-PEL): Comparison of Two Methods of Caries Risk Assessment in Children |
Actual Study Start Date : | June 1, 2019 |
Estimated Primary Completion Date : | June 1, 2021 |
Estimated Study Completion Date : | June 1, 2021 |
Arm | Intervention/treatment |
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Experimental: Multivariate risk assessment group (ICCMS®)
Multivariate risk assessment group (ICCMS®): multivariate caries risk assessment based on International Caries Classification and Management System (ICCMS™) guide
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Diagnostic Test: ICCMS
Risk caries assessment will consider ICCMS criteria
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Experimental: Simplified risk assessment group (dental caries experience)
Simplified risk assessment group (dental caries experience): simplified caries risk assessment based on dental caries experience (WHO criteria)
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Diagnostic Test: ICCMS
Risk caries assessment will consider ICCMS criteria
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Ages Eligible for Study: | 7 Years to 11 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marina S Azevedo, PhD | 555332602830 | marinasazevedo@gmail.com |
Brazil | |
Graduate Program in Dentistry | Recruiting |
Pelotas, RS, Brazil, 96015080 | |
Contact: Maximiliano S Cenci, PhD 555332606741 cencims@gmail.com | |
Sub-Investigator: Fausto M Mendes, PhD | |
Principal Investigator: Marina S Azevedo, PhD | |
Sub-Investigator: Mariana M Fraga, PhD | |
Sub-Investigator: Aryane M Menegaz, PhD | |
Sub-Investigator: Thays V Oliveira, MSc |
Tracking Information | |||||
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First Submitted Date ICMJE | May 29, 2019 | ||||
First Posted Date ICMJE | May 31, 2019 | ||||
Last Update Posted Date | July 7, 2020 | ||||
Actual Study Start Date ICMJE | June 1, 2019 | ||||
Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
New caries lesions [ Time Frame: from baseline (first measurement) to 24months ] Incremental number of dental surfaces with operative treatment needs. This outcome will be assessed by the new caries lesions and / or progression of lesions previously diagnosed / treated and number of treated surfaces which will need restoration replacement, endodontic treatment or extraction after the treatment plan.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Quality of life score [ Time Frame: from baseline (first measurement) to 24months ] Impact on oral health related quality of life measured by a validated questionnaire (CPQ)
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | CARDEC-PEL: Comparison of Two Methods of Caries Risk Assessment in Children | ||||
Official Title ICMJE | CARies DEtection in Children-Pelotas (CARDEC-PEL): Comparison of Two Methods of Caries Risk Assessment in Children | ||||
Brief Summary | The aim of the study was to compare dental caries treatment and follow-up based on an elaborate and individualized assessment of caries risk in children, to a simpler risk assessment strategy by means of a double-blind randomized clinical trial of two years monitoring. Participants will be children from 7 to 11 years old, who pass through the screening of the Children's Clinic of the Faculty of Dentistry of the Federal University of Pelotas and fulfill the inclusion criteria. A randomized, stratified sample of approximately 250 children will be included in the study, one group will be composed of children undergoing dental caries-related treatment and maintenance, guided by an individualized and multivariate risk assessment, and another group of children treated based on dental caries experience alone in the deciduous and / or permanent dentition. Recruitment will begin at the beginning of 2019, and participants will be followed up for 24 months. Parents will respond to an anamnesis, 24-hour dietary recall, food frequency questionnaire, and oral and general health-related quality of life questionnaire, children will undergo a clinical examination to assess caries, according to the International Caries Detection and Assessment System (ICDAS) in its simplified form and evaluation of caries activity. Dental treatments and return intervals will be designated according to the individual risk of the patient detected in the initial approach according to the group. The study evaluations consist of baseline, 12 months and 24 months, data will be transferred to spreadsheets after the different phases of the study. Primary outcomes (number of dental surfaces requiring operative intervention) and secondary outcomes will be analyzed by Student's t test, quality of life and quality of life related to oral health, will be assessed at the beginning of the study and at the end of treatment, and compared between the groups. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Caries,Dental | ||||
Intervention ICMJE | Diagnostic Test: ICCMS
Risk caries assessment will consider ICCMS criteria
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
250 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 1, 2021 | ||||
Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 7 Years to 11 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Brazil | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03969628 | ||||
Other Study ID Numbers ICMJE | PPGO 0030 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Maximiliano Sergio Cenci, Federal University of Pelotas | ||||
Study Sponsor ICMJE | Federal University of Pelotas | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Federal University of Pelotas | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |