The effect of ibuprofen on postoperative pain reduction following mini-screw insertion for orthodontic treatment
| ISRCTN | ISRCTN68332234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68332234 |
| Secondary identifying numbers | The National Natural Science Foundation of China Grant No. 31400836 |
- Submission date
- 16/12/2024
- Registration date
- 20/12/2024
- Last edited
- 19/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The present study aims to investigate the clinical efficacy of orally administered ibuprofen sustained-release capsules in providing preemptive analgesia during orthodontic mini-screw insertion for patients with malocclusion. The objective was to evaluate the impact of preoperative ibuprofen administration on postoperative pain following the insertion of a single posterior orthodontic mini-screw. This study endeavors to contribute to the body of knowledge regarding optimal pain management strategies for such procedures, aiming to enhance patient comfort and satisfaction during orthodontic treatment.
Who can participate?
Adult patients aged 18 to 50 years old requiring the insertion of a single mini-screw for orthodontic treatment
What does the study involve?
The experimental group received 300 mg of ibuprofen sustained-release capsules orally 30 minutes prior to surgery, while the control group received a placebo under the same conditions. Postoperative pain scores were recorded at 2, 4, 6, 8, 12, and 24 hours after surgery, and the amount of analgesic medication self-administered by patients within 24 hours was also documented.
What are the possible benefits and risks of participating?
Participants may help develop a safer and more effective form of pain relief. Risks include possible side effects of pain medication.
Where is the study run from?
Wuhan University Dental Hospital (China)
When is the study starting and how long is it expected to run for?
February 2024 to December 2024
Who is funding the study?
The National Natural Science Foundation of China
Who is the main contact?
Yang Wu, wuyang83@whu.edu.cn
Contact information
Public, Scientific, Principal Investigator
Wuhan University Dental Hospital
Wuhan
430079
China
| Phone | +86 137 2039 0002 |
|---|---|
| wuyang83@whu.edu.cn |
Study information
| Study design | Single-center intervention single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Diagnostic, Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | A randomized controlled trial assessing the effect of preoperative ibuprofen administration on postoperative pain reduction following mini-screw insertion for patients with malocclusion |
| Study objectives | Preoperative ibuprofen administration can reduce postoperative pain following mini-screw insertion for patients with malocclusion |
| Ethics approval(s) |
Approved 06/05/2024, The Ethics Committee of School & Hospital of Stomatology, Wuhan University (3F, Center Laboratory, Han University Dental Hospital, 237 Luoyu Road, Wuhan, 430079, China; 027-87686250; wdkqllwyh@163.com), ref: [WDKQ2024] LUNSHEN (B46) |
| Health condition(s) or problem(s) studied | Postoperative pain following mini-screw insertion for patients with malocclusion |
| Intervention | This study is a single-center intervention single-blind randomized controlled trial. Patients enrolled will be randomly assigned to two groups: an experimental and a control group. The experimenter used SAS software (9.4, USA) to generate a random number for each patient, then sorted the generated random numbers, and based on the sorting results, patients in the first half of the sorting were assigned to the experimental group, and those in the second half of the sorting were assigned to the control group, making sure that there were equal numbers of patients in each group, and recording the results of randomization. According to the randomization results, different drugs were packaged and distributed to patients in each group before surgery, and the drugs in both groups were in the same capsule dosage form with the same appearance. The experimental group will receive 300 mg of ibuprofen sustained-release capsules orally 30 minutes before surgery. The control group will receive a placebo capsule (300 mg/capsule, filled with starch) orally before surgery. Pain Relief Medication: Following surgery, subjects can self-administer ibuprofen sustained-release capsules based on their pain levels (reaching a Numerical Rating Scale (NRS) score of 3), while documenting the frequency and timing of administration. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ibuprofen sustained-release capsules |
| Primary outcome measure | Pain is measured using a Numerical Rating Scale (NRS) at baseline, 2, 4, 6, 8, 12, and 24 hours |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/02/2024 |
| Completion date | 15/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 68 |
| Key inclusion criteria | 1. Age range: 18 to 50 years old, inclusive 2. Absence of cardiopulmonary diseases, normal liver and kidney function, no history of abnormal bleeding or coagulation disorders 3. No use of analgesic, anti-inflammatory, or anticoagulant medications within one week before surgery 4. Requirement for the insertion of a single mini-screw for orthodontic treatment, with no need for other oral surgeries apart from orthodontic interventions 5. Normal bone density at the insertion site confirmed by cone-beam computed tomography (CBCT) 6. Voluntary participation in the study and completion of the survey questionnaire |
| Key exclusion criteria | 1. Pregnant or lactating women 2. Presence of systemic diseases such as coagulation disorders, cardiovascular and cerebrovascular diseases, or endocrine disorders 3. Allergic to the medication ibuprofen and the intraoperative medication articaine hydrochloride used in this study 4. Untreated dental pain conditions such as pulpitis, apical periodontitis, or trigeminal neuralgia requiring long-term analgesic use 5. Concurrent acute oral infections or tumors 6. Alcohol consumption within one week before surgery 7. Active or past history of peptic ulcer, gastrointestinal bleeding, or perforation 8. Current use of ibuprofen, selective cyclooxygenase-2 (COX-2) inhibitors, or other NSAIDs 9. Prior history of mini-screw insertion surgery |
| Date of first enrolment | 06/05/2024 |
| Date of final enrolment | 15/12/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Wuhan
430079
China
Sponsor information
Hospital/treatment centre
237 Luoyu Road
Wuhan
430079
China
| Phone | +86 027-87686110 |
|---|---|
| wdkqdzb@163.com | |
| Website | https://www.whuss.com/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 06/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/02/2025 | 19/02/2025 | Yes | No |
Editorial Notes
19/02/2025: Publication reference added.
17/12/2024: Study's existence confirmed by the Ethics Committee of the School & Hospital of Stomatology, Wuhan University.
