The effect of ibuprofen on postoperative pain reduction following mini-screw insertion for orthodontic treatment

A randomized controlled trial assessing the effect of preoperative ibuprofen administration on postoperative pain reduction following mini-screw insertion for patients with malocclusion

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68332234

Enrollment

Registered

2024-12-20

Start date

2024-05-06

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain following mini-screw insertion for patients with malocclusion Oral Health

Interventions

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 us

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Pain is measured using a Numerical Rating Scale (NRS) at baseline, 2, 4, 6, 8, 12, and 24 hours	—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

China

Contacts

Public ContactYang Wu

wuyang83@whu.edu.cn+86 137 2039 0002

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026