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出境医 / 临床实验 / CARDEC-PEL: Comparison of Two Methods of Caries Risk Assessment in Children

CARDEC-PEL: Comparison of Two Methods of Caries Risk Assessment in Children

Study Description
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.

Condition or disease Intervention/treatment Phase
Caries,Dental Diagnostic Test: ICCMS Not Applicable

Study Design
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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
Arms and Interventions
Arm Intervention/treatment
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
Diagnostic Test: ICCMS
Risk caries assessment will consider ICCMS criteria

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)
Diagnostic Test: ICCMS
Risk caries assessment will consider ICCMS criteria

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals aged 7 years months to 11 years;
  • Children seeking dental treatment at the Pediatric dentistry university clinic in Pelotas (UFPel)

Exclusion Criteria:

  • Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child
Contacts and Locations

Contacts
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Contact: Marina S Azevedo, PhD 555332602830 marinasazevedo@gmail.com

Locations
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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         
Sponsors and Collaborators
Federal University of Pelotas
Tracking Information
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
 (submitted: May 29, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
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)
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
Condition  ICMJE Caries,Dental
Intervention  ICMJE Diagnostic Test: ICCMS
Risk caries assessment will consider ICCMS criteria
Study Arms  ICMJE
  • 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
    Intervention: Diagnostic Test: ICCMS
  • 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)
    Intervention: Diagnostic Test: ICCMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019)
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:

  • Individuals aged 7 years months to 11 years;
  • Children seeking dental treatment at the Pediatric dentistry university clinic in Pelotas (UFPel)

Exclusion Criteria:

  • Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marina S Azevedo, PhD 555332602830 marinasazevedo@gmail.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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