Postoperative PainNCT03142672
Postoperative Pain and Recovery Time After Pulpotomy
A study testing pulpotomy and tooth filling in people with Postoperative Pain, run by Aydin Adnan Menderes University.
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. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- pulpotomy and tooth filling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 28 Jan 2016to 30 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children with special needs and those with any systematic problem (cardiac disease, diabetes, or intellectual disability) were excluded from the study.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- pulpotomy, tooth filling
- Keywords
- Postoperative pain, child, pulpotomy, general anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulpotomyProcedure or surgery
vital endodontic procedure
tooth fillingProcedure or surgery
tooth filling
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Pulpotomy and tooth filling Receives: Procedure: pulpotomy; Procedure: tooth filling |
| Control group | Active comparator | Tooth filling Receives: Procedure: tooth filling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores evaluation
Wong Baker Faces Scale
Measured: An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start28 Jan 2016
- Primary completion27 Apr 2016
- Study completion30 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SULTAN KELES, Aydin Adnan Menderes University
- Investigators
- Sultan Keles, Dr., Study director, Pediatric dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142672
- Sponsor's protocol ID
- 2016/764
- Status last verified
- May 2017
- First submitted
- 26 Apr 2017
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22652208
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Postoperative Pain and Recovery Time After Pulpotomy Performed Under General Anaesthesia in Young Children
- ClinicalTrials.gov ID
- NCT03142672
- Acronym / sponsor ID
- 2016/764
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, child, pulpotomy, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- 27 Apr 2016 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: pulpotomy, Procedure: tooth fillingPulpotomy and tooth filling |
| Control group | Active comparator | Procedure: tooth fillingTooth filling |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Children with special needs and those with any systematic problem (cardiac disease, diabetes, or intellectual disability) were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulpotomyvital endodontic procedure | Procedure or surgery | Experimental group |
| tooth fillingtooth filling | Procedure or surgery | Control group, Experimental group |
Primary outcome
Pain scores evaluation
Time frame: An average of 1 year
Wong Baker Faces Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Background: PubMed 22652208Jensen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sultan Keles, Dr. study director
Pediatric dentistry
Questions about this trial
What is this clinical trial studying?
A study testing pulpotomy and tooth filling in people with Postoperative Pain, run by Aydin Adnan Menderes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores evaluation (time frame: An average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03142672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.