Discomfort Evaluation During Atraumatic Restorative Treatment in Children
NCT ID: NCT03143387
Last Updated: 2018-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-06-01
2017-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Atraumatic Restorative Treatment
Partial removal of carious tissue using manual instruments.
Caries removal using only manual instruments
Caries removal using only manual instruments according to Atraumatic Restorative Treatment
Chemo-mechanical Removal
Partial removal of carious tissue using manual instruments and the material Chemo-mechanical removal group using Papacarie™gel.
Caries removal using Papacarie gel
Caries removal using a chemical-mechanical method - Papacarie gel and manual instruments.
Interventions
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Caries removal using only manual instruments
Caries removal using only manual instruments according to Atraumatic Restorative Treatment
Caries removal using Papacarie gel
Caries removal using a chemical-mechanical method - Papacarie gel and manual instruments.
Eligibility Criteria
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Inclusion Criteria
* in good general health conditions,
* cooperative during screening,
* with at least one oclusal caries cavity in primary molars.
* Caregivers and/or children's parents must accept and sign the consent form.
* Children must accept their participation by nodding (assent).
Exclusion Criteria
* spontaneous pain,
* mobility,
* fistula,
* swollen area around the tooth,
* furcation,
* cervical lesion,
* restorations,
* sealants,
* developmental defect of enamel.
4 Years
9 Years
ALL
No
Sponsors
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Faculty Sao Leopoldo Mandic Campinas
OTHER
Responsible Party
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Jose Carlos P Imparato
Principal Investigator
Locations
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Faculdade Sao Leopoldo Mandic
Campinas, São Paulo, Brazil
Countries
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References
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Berggren U, Meynert G. Dental fear and avoidance: causes, symptoms, and consequences. J Am Dent Assoc. 1984 Aug;109(2):247-51. doi: 10.14219/jada.archive.1984.0328.
Bussadori SK, Guedes CC, Bachiega JC, Santis TO, Motta LJ. Clinical and radiographic study of chemical-mechanical removal of caries using Papacarie: 24-month follow up. J Clin Pediatr Dent. 2011 Spring;35(3):251-4. doi: 10.17796/jcpd.35.3.75803m02524625h5.
Colares V, Franca C, Ferreira A, Amorim Filho HA, Oliveira MC. Dental anxiety and dental pain in 5- to 12-year-old children in Recife, Brazil. Eur Arch Paediatr Dent. 2013 Feb;14(1):15-9. doi: 10.1007/s40368-012-0001-8. Epub 2013 Jan 30.
Frencken JE, Holmgren CJ. Caries management through the Atraumatic Restorative Treatment (ART) approach and glass-ionomers: update 2013. Braz Oral Res. 2014;28:5-8. doi: 10.1590/S1806-83242013000600001. No abstract available.
Frencken JE, Leal SC, Navarro MF. Twenty-five-year atraumatic restorative treatment (ART) approach: a comprehensive overview. Clin Oral Investig. 2012 Oct;16(5):1337-46. doi: 10.1007/s00784-012-0783-4. Epub 2012 Jul 24.
Mattos-Silveira J, Floriano I, Ferreira FR, Vigano ME, Frizzo MA, Reyes A, Novaes TF, Moriyama CM, Raggio DP, Imparato JC, Mendes FM, Braga MM. New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:448. doi: 10.1186/1745-6215-15-448.
Simon AK, Bhumika TV, Nair NS. Does atraumatic restorative treatment reduce dental anxiety in children? A systematic review and meta-analysis. Eur J Dent. 2015 Apr-Jun;9(2):304-309. doi: 10.4103/1305-7456.156841.
Staman NM, Townsend JA, Hagan JL. Observational study: discomfort following dental procedures for children. Pediatr Dent. 2013 Jan-Feb;35(1):52-4.
Soares FC, Lima RA, Santos Cda F, de Barros MV, Colares V. Predictors of dental anxiety in Brazilian 5-7years old children. Compr Psychiatry. 2016 May;67:46-53. doi: 10.1016/j.comppsych.2016.01.006. Epub 2016 Jan 21.
Venkataraghavan K, Kush A, Lakshminarayana C, Diwakar L, Ravikumar P, Patil S, Karthik S. Chemomechanical Caries Removal: A Review & Study of an Indigen-ously Developed Agent (Carie Care (TM) Gel) In Children. J Int Oral Health. 2013 Aug;5(4):84-90. Epub 2013 Aug 28.
Other Identifiers
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ART discomfort
Identifier Type: -
Identifier Source: org_study_id