Impact of Detecting Initial and Active Caries Lesions in Primary Teeth
Study Details
Study Description
Brief Summary
The present study aims to evaluate the impact of detecting active initial caries lesions in primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary dentition will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Sao Paulo. The caries detection will be conducted using the International Caries Detection and Assessment System (ICDAS) and, depending on allocation, an adjunct criterion for caries activity assessment. Children will be randomized in two groups according to the caries threshold to be detected: Group A (only advanced lesions will be detected and treated, independently of their activity status) and Group B (all caries lesions, including initial ones, will be detected and all active lesions will be treated). After this, the treatment plan for each child will be made according to strategies mentioned above. Data concerning the cost-effectiveness of the procedures, acceptability / satisfaction of children and quality of life will be collected after diagnosis, after the end of treatment and 12 and 24 months from the initial examination. For comparison between groups, multilevel regression analyses will be performed. The primary outcome will be sites which need of operative treatment during the follow-up periods and the secondary outcomes will be the cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the impact on quality of life.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Control Caries Detection Strategy Detection and treatment based on more advanced lesions, despite activity status - Advanced caries lesions detection (no activity assessment) |
Other: Advanced caries lesions detection (no activity assessment)
The diagnosis strategy will based on detection of only moderate and advanced caries lesions (ICDAS scores 3 to 6). Initial caries lesions will be considered as sound surfaces. Caries activity status will not be evaluated. Clinical decision-making will be proposed for all lesions detected, based on evidence-based protocols.
Other Names:
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| Other: Test Caries Detection Strategy Detection and treatment based on all detected caries lesions, considering their activity status as a differential in clinical decision-making - All caries lesions detection (+activity assessment) |
Other: All caries lesions detection (+activity assessment)
The diagnosis strategy will based on detection of initial, moderate and advanced caries lesions (ICDAS scores 1 to 6). Caries activity status will be also evaluated. Clinical decision-making will be proposed for all active lesions detected, based on evidence-based protocols. inactive caries lesions will not be treated.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incremental number of dental surfaces with operative treatment needs [After 12 and 24 months from allocation]
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 initial treatment.
Secondary Outcome Measures
- Cost-efficacy [After 12 and 24 months from the allocation]
The costs of the diagnostic strategy will be calculated and compared with threshold values for intervention cost-effectiveness by region, determined by World Health Organization.
- Discomfort [immediately after the allocation and after 12 and 24 months]
Participants' discomfort, measured by a validated scale (Wong-Baker scale).
- Impact of oral health on quality of life [12 and 24 months after the allocation]
Impact of oral health on quality of life of the children participants in the study, measured by a validated questionnaire (ECOHIS).
Other Outcome Measures
- Costs [Immediately after allocation]
The costs of each diagnostic strategy and treatment based on that will be calculated, regarding time of each clinical session, materials used, duration of treatment and possible repetitions.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Individuals aged 36 months to 83 months;
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Should have complete primary dentition;
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Children must assent to participate and their parents must consent to their participation by signing the consent form.
Exclusion Criteria:
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Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child;
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Children involved in other research that may impact on this study;
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Families who are expected to move out of the coverage area of study during the first year of enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Sao Paulo | Sao Paulo | Brazil | 05508000 |
Sponsors and Collaborators
- University of Sao Paulo
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
- Principal Investigator: Mariana M Braga, University of Sao Paulo
- Principal Investigator: Isabela Floriano, University of Sao Paulo
- Principal Investigator: Fausto M Mendes, University of Sao Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
- Baelum V, Heidmann J, Nyvad B. Dental caries paradigms in diagnosis and diagnostic research. Eur J Oral Sci. 2006 Aug;114(4):263-77. Review.
- Baelum V, Machiulskiene V, Nyvad B, Richards A, Vaeth M. Application of survival analysis to carious lesion transitions in intervention trials. Community Dent Oral Epidemiol. 2003 Aug;31(4):252-60.
- Ekstrand KR. Improving clinical visual detection--potential for caries clinical trials. J Dent Res. 2004;83 Spec No C:C67-71. Review.
- Garber AM, Phelps CE. Economic foundations of cost-effectiveness analysis. J Health Econ. 1997 Feb;16(1):1-31.
- Harris R, Gamboa A, Dailey Y, Ashcroft A. One-to-one dietary interventions undertaken in a dental setting to change dietary behaviour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD006540. doi: 10.1002/14651858.CD006540.pub2. Review.
- Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8.
- Ismail AI. Clinical diagnosis of precavitated carious lesions. Community Dent Oral Epidemiol. 1997 Feb;25(1):13-23. Review.
- JOE Editorial Board. Treatment of the primary tooth: an online study guide. J Endod. 2008 May;34(5 Suppl):e107-10. doi: 10.1016/j.joen.2007.08.004. Review.
- Kidd E, Fejerskov O. Changing concepts in cariology: forty years on. Dent Update. 2013 May;40(4):277-8, 280-2, 285-6.
- Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012 Aug;91(8):753-8. doi: 10.1177/0022034512452278. Epub 2012 Jun 26.
- Martins-Júnior PA, Ramos-Jorge J, Paiva SM, Marques LS, Ramos-Jorge ML. Validations of the Brazilian version of the Early Childhood Oral Health Impact Scale (ECOHIS). Cad Saude Publica. 2012 Feb;28(2):367-74.
- Mendes FM, Braga MM, Oliveira LB, Antunes JL, Ardenghi TM, Bönecker M. Discriminant validity of the International Caries Detection and Assessment System (ICDAS) and comparability with World Health Organization criteria in a cross-sectional study. Community Dent Oral Epidemiol. 2010 Oct;38(5):398-407. doi: 10.1111/j.1600-0528.2010.00557.x.
- Nyvad B, Fejerskov O. Assessing the stage of caries lesion activity on the basis of clinical and microbiological examination. Community Dent Oral Epidemiol. 1997 Feb;25(1):69-75. Review.
- Nyvad B. Diagnosis versus detection of caries. Caries Res. 2004 May-Jun;38(3):192-8. Review.
- Piovesan C, Ardenghi TM, Guedes RS, Ekstrand KR, Braga MM, Mendes FM. Activity assessment has little impact on caries parameters reduction in epidemiological surveys with preschool children. Community Dent Oral Epidemiol. 2013 Jun;41(3):204-11. doi: 10.1111/cdoe.12004. Epub 2012 Sep 25.
- Pitts NB. Are we ready to move from operative to non-operative/preventive treatment of dental caries in clinical practice? Caries Res. 2004 May-Jun;38(3):294-304. Review.
- Ricketts DN, Kidd EA, Innes N, Clarkson J. Complete or ultraconservative removal of decayed tissue in unfilled teeth. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD003808. Review. Update in: Cochrane Database Syst Rev. 2013;3:CD003808.
- Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2. Review. Update in: Cochrane Database Syst Rev. 2019 Mar 04;3:CD007868.
- Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17.
- CARDEC-02