Pre-operative effects of anti-inflammatory drugs on pain and inflammation following wisdom teeth removal.

Phase 4

Not yet recruiting

• Conditions: Impacted third molars (wisdom teeth); Post-operative pain; Post-operative swelling; Trismus; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Anaesthesiology - Pain management

• Registration Number: ACTRN12618001908224
• Lead Sponsor: Faculty of Dentistry, University of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-23
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

All prospective participants must be seen by the principal investigator with the guidance from a Consultant Oral and Maxillofacial Surgeon (principal supervisor and co-supervisors) at the School of Dentistry, University of Otago.
i. Patients must be deemed appropriately suitable for participation in the present study by the principal investigator or a Consultant Oral and Maxillofacial Surgeon (principal supervisor and co-supervisors) at the School of Dentistry, University of Otago.
ii. The participant must be aged between 18 and 35 years.
iii. The participant must legitimately require removal of at least two mandibular third molars (and may require removal of maxillary third molar/s) as per third molar surgical protocol at the School of Dentistry, University of Otago.
iv. Expected bone removal and/or tooth sectioning for extraction of the impacted bilateral mandibular third molars.
v. The participant must be medically fit (American Society of Anaesthesiologist (ASA) physical status classification 1 or 2) to have their third molars removed.
vi. The participant must be assessed as appropriate for an intravenous (IV) sedation.
vii. The participant must consent to having their third molars removed under IV sedation and local anaesthesia.
viii. There will be no discrimination based on gender, race, and ethnicity. Non-English-speaking patients will be given equal opportunity to participate; an accredited interpreter will be employed as required.

Exclusion Criteria

i. Patients under the age of 18 years and over 35 years of age
ii. Patients are excluded if they meet any of the following criteria:
1. Any significant systemic disease/s classified as ASA 3, 4, or 5
2. Active/history of gastrointestinal bleeding or ulceration
3. Currently pregnant or lactating
4. Body weight >120kg
5. Cardiovascular disease classified under ASA 3, 4, or 5
6. Non-steroidal anti-inflammatory drug (NSAID)-sensitive asthma
7. Respiratory depression, chronic obstructive pulmonary disease
8. Hepatic impairment
9. Renal impairment
10. Bleeding disorders
11. Therapeutic anticoagulation
12. Bone disorders
13. Metabolic diseases
14. Patients of bisphosphonates
15. Patients on long-term benzodiazepines, opioids, and liver enzyme induction agents/medications
16. Hypersensitivity to benzodiazepines, etoricoxib, ibuprofen, and codeine phosphate
17. Use of NSAIDs within 48 hours prior to the day of surgery
18. Presence of swelling, fever, trismus prior to third molar surgery
19. Opioid and illicit drug addiction
20. Alcoholism
21. Current smokers who refuse to stop smoking within 72 hours following third molar surgery
22. Patients opting to undergo third molar surgery under local or general anaesthesia
23. Patients unable to give informed consent
iii. Patients who have third molars with following:
1. Associated pathologies
2. Third molar/s requiring coronectomy
3. Third molars with higher risk of mandibular fracture
4. Maxillary third molar/s with higher risk of oro-antral communication
5. Oral surgery requiring more than four third molars extracted

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative pain intensity assessed using a non-graduated 100mm Visual Analogue Scale (VAS)[Baseline (pre-operative), then every 3 hours, while awake, for the first 48 hours post-surgery (with the timepoint being 48 hours post-surgery),<br>The 48 hour timepoint is the primary timepoint]