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Postoperative Pain and Recovery Time After Pulpotomy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulpotomy
tooth filling
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Pain focused on measuring Postoperative pain, child, pulpotomy, general anesthesia

Eligibility Criteria

3 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    Pulpotomy and tooth filling

    Tooth filling

    Outcomes

    Primary Outcome Measures

    Pain scores evaluation
    Wong Baker Faces Scale

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2017
    Last Updated
    May 4, 2017
    Sponsor
    Aydin Adnan Menderes University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03142672
    Brief Title
    Postoperative Pain and Recovery Time After Pulpotomy
    Official Title
    Immediate Postoperative Pain and Recovery Time After Pulpotomy Performed Under General Anaesthesia in Young Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 28, 2016 (Actual)
    Primary Completion Date
    April 27, 2016 (Actual)
    Study Completion Date
    May 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aydin Adnan Menderes University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    Postoperative pain, child, pulpotomy, general anesthesia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Pulpotomy and tooth filling
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Tooth filling
    Intervention Type
    Procedure
    Intervention Name(s)
    pulpotomy
    Intervention Description
    vital endodontic procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    tooth filling
    Intervention Description
    tooth filling
    Primary Outcome Measure Information:
    Title
    Pain scores evaluation
    Description
    Wong Baker Faces Scale
    Time Frame
    An average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sultan Keles, Dr.
    Organizational Affiliation
    Pediatric dentistry
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    22652208
    Citation
    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.
    Results Reference
    background

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    Postoperative Pain and Recovery Time After Pulpotomy

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