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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03142672
Other study ID # 2016/764
Secondary ID
Status Completed
Phase N/A
First received April 26, 2017
Last updated May 4, 2017
Start date January 28, 2016
Est. completion date May 30, 2016

Study information

Verified date May 2017
Source Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this retrospective study was to compare immediate postoperative pain scores and the need for rescue analgesia in children who underwent pulpotomies and general restorative treatment and those who underwent general restorative treatment only, all under general anaesthesia.


Description:

Ninety patients aged between 3 and 7 years who underwent full mouth dental rehabilitation under general anaesthesia were enrolled in the study and reviewed. The experimental group included patients who were treated with at least one pulpotomy, and the control group was treated with dental fillings only. The Wong-Baker FACES scale was used to evaluate self-reported pain and the need for rescue analgesia. The data were analysed using the Kruskal-Wallis test, two sample t- tests, chi-square tests and Pearson's correlation analysis.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 30, 2016
Est. primary completion date April 27, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 7 Years
Eligibility Inclusion Criteria:

- Patients who underwent full mouth dental rehabilitation under GA because of their lack of chairside cooperation

- Patients with at least 1 pulpotomy were included in the experimental group (n=45), and patients treated with dental fillings only were included in the control group (n=45); a total of 90 patients were eligible for the study.

Exclusion Criteria:

- Children with special needs and those with any systematic problem (cardiac disease, diabetes, or intellectual disability) were excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
pulpotomy
vital endodontic procedure
tooth filling
tooth filling

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Adnan Menderes University

References & Publications (1)

Jensen B. Post-operative pain and pain management in children after dental extractions under general anaesthesia. Eur Arch Paediatr Dent. 2012 Jun;13(3):119-25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain scores evaluation Wong Baker Faces Scale An average of 1 year
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