NCT03142672

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable postoperative-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

April 26, 2017

Last Update Submit

May 4, 2017

Conditions

Postoperative Pain

Keywords

Postoperative painchildpulpotomygeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Pain scores evaluation

    Wong Baker Faces Scale

    An average of 1 year

Study Arms (2)

Experimental group

EXPERIMENTAL

Pulpotomy and tooth filling

Procedure: pulpotomyProcedure: tooth filling

Control group

ACTIVE COMPARATOR

Tooth filling

Procedure: tooth filling

Interventions

pulpotomyPROCEDURE

vital endodontic procedure

Experimental group
tooth fillingPROCEDURE

tooth filling

Control groupExperimental group

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1007/BF03262857.

    PMID: 22652208BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Officials

  • Sultan Keles, Dr.

    Pediatric dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.Dr.

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 5, 2017

Study Start

January 28, 2016

Primary Completion

April 27, 2016

Study Completion

May 30, 2016

Last Updated

May 5, 2017

Record last verified: 2017-05