Skip to content

Efficacy of preemptive ibuprofen combined with paracetamol in lower third molar surgery: a double-blind randomized controlled clinical trial

Efficacy of preemptive ibuprofen combined with paracetamol in lower third molar surgery: a double-blind randomized controlled clinical trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210604006
Enrollment
88
Registered
2021-06-04
Start date
2019-09-23
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Postoperative pain severity after third molar surgery will be moderate to severe pain during 6-12 hr. postoperatively. Analgesic drugs used after surgery do not be effective pain reduction. Postoperative pain , third molar surgery

Interventions

Ibuprofen 400 mg 1 tab orally and paracetamol 500 mg 1 tab orally before operation 1 hour.,One placebo (starch) mimic ibuprofen 400 mg 1 tab orally and one placebo (starch) mimic paracetamol 500 mg 1
Experimental Drug,Placebo Comparator Drug
ibuprofen 400 mg combined paracetamol 500 mg,Two placebos (mimic ibuprofen and paracetamol in each)

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. Healthy (American Society of Anesthesiologists (ASA) classification I and II) 2. Age 18 to 30 years 3. Clear indication for removal of lower third molars 4. Moderate difficulty of lower third molar (Pederson 's difficulty index 5 to 6 score) 5. An absence of periodontal disease, infection, swelling prior to surgery

Exclusion criteria

Exclusion criteria: 1.A history of hypersensitivity to NSAIDs and/or paracetamol 2.Taking analgesic medications, such as aspirin, paracetamol, NSAIDs, opioids, or any other agents that could confound the analgesic and safety/tolerability responses; the washout periods were between 24 hours and 2 weeks, depending on the half-life of the respective medications. 3.Taking medications known to interact with the study medications. 4.Patients with a history of severe asthma, gastrointestinal disorders such as gastric ulceration; hematologic, renal or hepatic disease; immunosuppressive disorder; neurological disorder affecting pain perception 5.Pregnant or lactating women 6.Smoker

Design outcomes

Primary

MeasureTime frame
Pain score (visual analog scale) 5 years millimeter,Number of pain free patient 5 years number,Time at first requirement for rescue medications 5 years minute,Number of patients who received rescue medications 5 years number,Drug satisfaction (visual analog scale) 5 years millimeter

Secondary

MeasureTime frame
Facial swelling 5 years millimeter,Mouth opening 5 years millimeter

Countries

Thailand

Contacts

Public ContactPichai Vittayakittipong

Faculty of Dentistry, Prince of Songkla University

pichai.v@hotmail.com0816981083

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026