Impact of Detecting Initial and Active Caries Lesions in Primary Teeth

Dental Caries Clinical Trial

Official title:

CARies DEtection in Children - Cost-efficacy, Applicability and Impact on Quality of Life of Detecting Active Initial Caries Lesions in Primary Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473107
• Other study ID #: CARDEC-02
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2018

Study information

• Verified date: December 2022
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months to 83 Months

Eligibility

Inclusion Criteria:

• Individuals aged 36 months to 83 months;

• Should have complete primary dentition;

• Children must assent to participate and their parents must consent to their participation by signing the consent form.

Exclusion Criteria:

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

• Children involved in other research that may impact on this study;

• Families who are expected to move out of the coverage area of study during the first year of enrollment.

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (20)

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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. doi: 10.1034/j.1600-0528.2003.00045.x. — View Citation

Ekstrand KR. Improving clinical visual detection--potential for caries clinical trials. J Dent Res. 2004;83 Spec No C:C67-71. doi: 10.1177/154405910408301s13. — View Citation

Floriano I, Bonini GC, Matos R, Novaes TF, Ekstrand KR, Mendes FM, Braga MM. How different do visuo-tactile criteria assess caries lesions activity status on occlusal surfaces? Oral Dis. 2015 Apr;21(3):299-307. doi: 10.1111/odi.12265. Epub 2014 Aug 14. — View Citation

Garber AM, Phelps CE. Economic foundations of cost-effectiveness analysis. J Health Econ. 1997 Feb;16(1):1-31. doi: 10.1016/s0167-6296(96)00506-1. — View Citation

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;2012(3):CD006540. doi: 10.1002/14651858.CD006540.pub2. — View Citation

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. doi: 10.1111/j.1600-0528.2007.00347.x. — View Citation

Ismail AI. Clinical diagnosis of precavitated carious lesions. Community Dent Oral Epidemiol. 1997 Feb;25(1):13-23. doi: 10.1111/j.1600-0528.1997.tb00895.x. — View Citation

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. — View Citation

Kidd E, Fejerskov O. Changing concepts in cariology: forty years on. Dent Update. 2013 May;40(4):277-8, 280-2, 285-6. doi: 10.12968/denu.2013.40.4.277. — View Citation

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. — View Citation

Martins-Junior 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. doi: 10.1590/s0102-311x2012000200015. — View Citation

Mendes FM, Braga MM, Oliveira LB, Antunes JL, Ardenghi TM, Bonecker 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. — View Citation

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. doi: 10.1111/j.1600-0528.1997.tb00901.x. — View Citation

Nyvad B. Diagnosis versus detection of caries. Caries Res. 2004 May-Jun;38(3):192-8. doi: 10.1159/000077754. — View Citation

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. — View Citation

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. doi: 10.1159/000077769. — View Citation

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. doi: 10.1002/14651858.CD003808.pub2. — View Citation

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. — View Citation

Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Costs	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.	Immediately after allocation
Primary	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 initial treatment.	After 12 and 24 months from allocation
Secondary	Cost-efficacy	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.	After 12 and 24 months from the allocation
Secondary	Discomfort	Participants' discomfort, measured by a validated scale (Wong-Baker scale).	immediately after the allocation and after 12 and 24 months
Secondary	Impact of oral health on quality of life	Impact of oral health on quality of life of the children participants in the study, measured by a validated questionnaire (ECOHIS).	12 and 24 months after the allocation