- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03142672
Postoperative Pain and Recovery Time After Pulpotomy
May 4, 2017 updated by: SULTAN KELES, Aydin Adnan Menderes University
Immediate Postoperative Pain and Recovery Time After Pulpotomy Performed Under General Anaesthesia in Young Children
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 7 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental group
Pulpotomy and tooth filling
|
vital endodontic procedure
tooth filling
|
ACTIVE_COMPARATOR: Control group
Tooth filling
|
tooth filling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain scores evaluation
Time Frame: An average of 1 year
|
Wong Baker Faces Scale
|
An average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sultan Keles, Dr., Pediatric dentistry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 28, 2016
Primary Completion (ACTUAL)
April 27, 2016
Study Completion (ACTUAL)
May 30, 2016
Study Registration Dates
First Submitted
April 26, 2017
First Submitted That Met QC Criteria
May 4, 2017
First Posted (ACTUAL)
May 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 5, 2017
Last Update Submitted That Met QC Criteria
May 4, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/764
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
Clinical Trials on pulpotomy
-
University GhentCompleted
-
Cairo UniversityNot yet recruiting
-
Postgraduate Institute of Dental Sciences RohtakRecruitingPulpitis - IrreversibleIndia
-
Cairo UniversityUnknownSymptomatic Irreversible Pulpitis
-
British University In EgyptAin Shams UniversityRecruiting
-
University of Alabama at BirminghamNot yet recruitingIrreversible PulpitisUnited States
-
Jordan University of Science and TechnologyActive, not recruiting
-
Universitat Internacional de CatalunyaUnknownEvaluate the Effects of MEDCEM PC and MTA in Pulpotomies of Primary Molars.Spain
-
National University Health System, SingaporeCompletedPulpitis | Pulp Exposure, Dental | Pulp and Periapical Tissue Disease