Clinical trial NCT03143387: Discomfort Evaluation During Atraumatic Restorative Treatment in Children
Official title: Discomfort Evaluation During Atraumatic Restorative Treatment in Children- Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Primary Teeth
Post Dental Restoration
Lead sponsor: Faculty Sao Leopoldo Mandic Campinas
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 ™.

Eligibility criteria: 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.

Primary outcomes:
measure: Discomfort evaluation with Wong-Baker
timeFrame: immediately after treatment
measure: Discomfort evaluation with heart beat and oxygen saturation
timeFrame: 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 outcomes:
measure: Time of restorative procedure
timeFrame: Will be evaluated the time required for removal of the caries tissue only with manual removal and when manual removal with the product Papacárie ™
measure: Operators satisfaction
timeFrame: immediately after treatment
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Faculdade Sao Leopoldo Mandic
state: SP
Study officials:
References:
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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):304-309. doi: 10.4103/1305-7456.156841.
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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.
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.