Postoperative Pain and Recovery Time After Pulpotomy

NCT ID: NCT03142672

Last Updated: 2017-05-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-28

Study Completion Date

2016-05-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Experimental group

Pulpotomy and tooth filling

Group Type EXPERIMENTAL

pulpotomy

Intervention Type PROCEDURE

vital endodontic procedure

tooth filling

Intervention Type PROCEDURE

tooth filling

Control group

Tooth filling

Group Type ACTIVE_COMPARATOR

tooth filling

Intervention Type PROCEDURE

tooth filling

Interventions

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pulpotomy

vital endodontic procedure

Intervention Type PROCEDURE

tooth filling

tooth filling

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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SULTAN KELES

Assist. Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sultan Keles, Dr.

Role: STUDY_DIRECTOR

Pediatric dentistry

References

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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. doi: 10.1007/BF03262857.

Reference Type BACKGROUND
PMID: 22652208 (View on PubMed)

Other Identifiers

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2016/764

Identifier Type: -

Identifier Source: org_study_id

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