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Pain and child anxiety perceived during atraumatic and conventional restorative treatments by 5-to 8-yr-old school children

Perception of pain and anxiety related to atraumatic restorative treatment (ART) and conventional treatment by 5-to 8-yr-old school children - ART: Atraumatic Restorative Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-69zxf4
Enrollment
Unknown
Registered
2016-04-26
Start date
2015-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Toothache, dental anxiety

Interventions

Intervention group: 79 children received the atraumatic restorative treatment (ART) during dental appointment of 30 minutes, in a day of week previously scheduled. Control group: 79 children received
Procedure/surgery
D25.339.208.291

Sponsors

Faculdade de Odontologia e Centro de pesquisas São Leopoldo Mandic
Lead Sponsor
REGINA N M TAVARES
Collaborator
Flavia Martão Flório
Collaborator

Eligibility

Age
5 Years to 8 Years

Inclusion criteria

Inclusion criteria: 6- to 8-yr-old children with good systemic conditions, have at least two bilateral decayed primary molars with Black's class-II dentinal caries cavity, without pain,pulp involvement and periapical lesion, signed individual informed consent forms by parents and children, to accept the restorative treatment without local anaesthesia in the dentist appointment day

Exclusion criteria

Exclusion criteria: children under 5 years or over 8 years, have less than two bilateral decayed primary molars in the mouth, teeth with pain, apical lesions, and pulp involvement, use of anesthesia during the procedure on the day of the dentist appointment day, individual informed consent form not signed by the parents or the child

Design outcomes

Primary

MeasureTime frame
Expected outcomes: Lower levels of previous anxiety and dental pain in children submitted to the atraumatic restorative treatment in two treatment sessions. For assessment of anxiety will be used heart rate (frequency meter) before the procedure and scale FIS faces which comprises a row of five faces, each face has a scaled value of 1 (more positive) to 5 (more negative). For pain assessment will be used heart rate (frequency meter) during the performance of the restorations and the scale of Wong-Baker which comprises a row of six faces, each face represents a variation of pain degree with scores ranging from 0 (no pain) to a 5 (extreme pain). For the realization of the expected outcome will be performed a comparison between responses to pain' and anxiety' scales of the test group and the control group, as well as a comparison between the heart rates (before and during procedures) of both groups. Variation of at least 5% in each scale and heart rate will be considered. ;Found outcomes: The previous anxiety was not different between the two groups (intervention and control) when the intervention group was treated in the first session, but the pain levels were higher in the control group. Scores FIS scale and heart rate before the procedures did not differ between the two groups. The scores of the Wong-Baker scale and heart rate while performing the procedures were higher in the control group. A variation of 5% in the responses FIS escale and heart rate was admitted.

Secondary

MeasureTime frame
Expected outcome: Higher levels of previous anxiety and pain in the control group in the two treatment sessions. To the evaluate of previous anxiety was used FIS scale and heart rate. For determining the expected outcome will be performed comparing the two answers two groups will be accepted scores greater than 0 and 1 in the FIS scale and heart rate above 110 bpm as a positive response to previous anxiety. a variation of 5% in scale and heart rate was considered. ;Outcome found: Lower previous anxiety levels in the control group in the second treatment session. To evaluate the variable previous anxiety was used FIS scale and heart rate. For determining the expected outcome compared the responses of the two groups. A variation of 5% in scale and heart rate was considered.

Countries

Brazil

Contacts

Public ContactFLAVIA;Flavia FLÓRIO;Flório

Faculdade de Odontologia e Centro de pesquisas São Leopoldo Mandic;Faculdade de Odontologia e Centro de pesquisas São Leopoldo Mandic

flaviaflorio@yahoo.com;flaviaflorio@yahoo.com+55193211-3600;:(19) 3518-3600

Outcome results

None listed

Source: REBEC (via WHO ICTRP)