Discomfort Evaluation During Atraumatic Restorative Treatment in Children

Dental Caries Clinical Trial

Official title:

Discomfort Evaluation During Atraumatic Restorative Treatment in Children- Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143387
• Other study ID #: ART discomfort
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: December 2018
• Source: Faculty Sao Leopoldo Mandic Campinas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the patient 's discomfort when submitted to partial caries removal through the atraumatic restorative treatment compared to chemo-mechanical caries removal using Papacarie™ gel.

Description:

This study will evaluate the patient 's discomfort through oximeter (measuring the heart rate of the caries) prior to removal of the carious tissue, and when subjected to partial caries removal through the atraumatic restorative treatment compared to removal of chemo - mechanical caries with Papacarie gel ™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2017
• Est. primary completion date: October 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

Inclusion Criteria:

• normoreactive,

• 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:

• pulp exposition,

• spontaneous pain,

• mobility,

• fistula,

• swollen area around the tooth,

• furcation,

• cervical lesion,

• restorations,

• sealants,

• developmental defect of enamel.

Related Conditions & MeSH terms

• Dental Caries
• Post Dental Restoration
• Primary Teeth

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Faculdade Sao Leopoldo Mandic	Campinas	SP

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Sao Leopoldo Mandic Campinas

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

Berggren U, Meynert G. Dental fear and avoidance: causes, symptoms, and consequences. J Am Dent Assoc. 1984 Aug;109(2):247-51. — View Citation

Bussadori SK, Guedes CC, Bachiega JC, Santis TO, Motta LJ. Clinical and radiographic study of chemical-mechanical removal of caries using Papacárie: 24-month follow up. J Clin Pediatr Dent. 2011 Spring;35(3):251-4. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Mattos-Silveira J, Floriano I, Ferreira FR, Viganó 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. — View Citation

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):304-9. doi: 10.4103/1305-7456.156841. Review. — View Citation

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. — View Citation

Staman NM, Townsend JA, Hagan JL. Observational study: discomfort following dental procedures for children. Pediatr Dent. 2013 Jan-Feb;35(1):52-4. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort evaluation with Wong-Baker	The discomfort of each type of treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1998).; This scale indicates the discomfort of an individual who has to choose among six faces. The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort. The participant will be asked to choose the face that is more similar to how he/she felt during the treatment immediately after the procedure. This answer should be given solely by the child, which means no parental or professional interference	immediately after treatment
Primary	Discomfort evaluation with heart beat and oxygen saturation		Before the procedure (when the patient is in the dental chair and there is no intervention), and during the procedure (removal of the cavity tissue).
Secondary	Time of restorative procedure		Will be evaluated the time required for removal of the caries tissue only with manual removal and when manual removal with the product Papacárie ™
Secondary	Operators satisfaction		immediately after treatment