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Trial registered on ANZCTR


Registration number
ACTRN12618001908224
Ethics application status
Approved
Date submitted
6/10/2018
Date registered
23/11/2018
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pre-operative effects of anti-inflammatory drugs on pain and inflammation following wisdom teeth removal.
Scientific title
Pre-emptive analgesic and anti-inflammatory effects of etoricoxib and sustained-release ibuprofen following impacted mandibular third molar surgery.
Secondary ID [1] 295152 0
None
Universal Trial Number (UTN)
U1111-1216-0632
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impacted third molars (wisdom teeth) 308250 0
Post-operative pain 308251 0
Post-operative swelling 308252 0
Trismus 308253 0
Condition category
Condition code
Oral and Gastrointestinal 307274 307274 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 308795 308795 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Etoricoxib 120mg capsule

- Etoricoxib 120mg will be prepared in 4 capsules in divided doses (each capsule will contain 30mg of etoricoxib)
I.e. all 4 capsules of etoricoxib (120mg) will be administered orally as a single dose 2 hours pre-operatively under direct supervision/observation by the principal researcher
Intervention code [1] 301488 0
Treatment: Drugs
Comparator / control treatment
Sustained-release ibuprofen 1.6g capsule

- Sustained-release ibuprofen 1.6g will be prepared in 4 capsules in divided doses (each capsule will contain 400mg of sustained-release ibuprofen).
I.e. all 4 capsules of sustained-release ibuprofen (1.6g) will be administered orally as a single dose 2 hours pre-operatively under direct supervision/observation by the principal researcher
Control group
Active

Outcomes
Primary outcome [1] 306231 0
Post-operative pain intensity assessed using a non-graduated 100mm Visual Analogue Scale (VAS)
Timepoint [1] 306231 0
Baseline (pre-operative), then every 3 hours, while awake, for the first 48 hours post-surgery (with the timepoint being 48 hours post-surgery),
The 48 hour timepoint is the primary timepoint
Secondary outcome [1] 347922 0
Post-operative facial swelling using a 3dMDTrio 3-Dimensional imaging system

Instrument:
3dMDTrio 3-Dimensional imaging system will be used
Timepoint [1] 347922 0
Baseline (pre-operative), then at 48 hours post-surgery
Secondary outcome [2] 347923 0
Post-operative trismus using a standard ruler (in millimetres)
Timepoint [2] 347923 0
Baseline (pre-operative), then at 48 hours post-surgery

Instrument:
A standard ruler (in millimetres) will be used to measure the distance between the mesio-incisal edges of the right maxillary and mandibular central incisor teeth during maximal mouth opening
Secondary outcome [3] 347924 0
Determine whether there are any differences between etoricoxib group and sustained-release ibuprofen group in the need for rescue analgesia
Timepoint [3] 347924 0
At 24 hours and 48 hours post-surgery

Instrument:
Questions that ask participants to record the following details:
1. The time elapsed between the end of the surgery and the first use of rescue analgesia (at 24 hours post-surgery)
2. Number of rescue analgesia consumed per day (24 hours and 48 hours post-surgery)
Secondary outcome [4] 347925 0
Determine whether there are any differences in the adverse events between etoricoxib group and sustained-release ibuprofen group

Examples of adverse events: headache, drowsiness, dizziness, nausea, vomiting, stomache (epigastric) pain
Timepoint [4] 347925 0
At 48 hours post-surgery

Instrument:
Data on adverse events will be collected in the form of a short questionnaire (development in progress)
Secondary outcome [5] 347926 0
Overall satisfaction with pain control and a self-reported quality of life using the Oral Health Impact Profile (OHIP-14) questionnaire (Slade, 1997)
Timepoint [5] 347926 0
Baseline (pre-operative), then at 48 hours post-surgery

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be given a unique identification number by the pharmacist and treatment will be provided via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used to ensure balance in the assignment of participants to each treatment group. An independent biostatistician will generate a random allocation sequence. A hospital clinical trials pharmacist, the only non-blinded person involved in the proposed study, will hold this computer-generated randomisation code. Upon receiving participation consent, the pharmacist will randomly assign each participant to either the intervention group (group A) or the control group (group B) according to the randomisation code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size determination
The sample size calculation was based on that described in the study conducted by Al-Sukhun et al. 70% of patients who received celecoxib rated the study medication as good, very good, or excellent, while it was only 58% among patients who received ibuprofen and 15% among patients who received a placebo. Assuming an a value of 0.05 and 80% power to detect a difference, the estimate number of patients per group is 61. Thus, a minimum of 122 patients will be required.

Data analysis
Statistical analysis will be undertaken using SPSS software. Baseline characteristics and categorical data will be compared using Chi-square tests. The summary data on visual analogue scale (VAS), swelling, and trismus between etoricoxib and ibuprofen groups will be compared and tested for statistical significance using Analysis of Variance. Pearson correlations will also be used to quantify the association between the sum of pain scores and the total intake of rescue medication. Linear regression will be used to control for confounders. The level of significance will be set at P <0.05. Appropriate multivariate modelling will be undertaken.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2019
Actual
Date of last participant enrolment
Anticipated
2/12/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
122
Accrual to date
Final
Recruitment outside Australia
Country [1] 10542 0
New Zealand
State/province [1] 10542 0
Dunedin, Otago

Funding & Sponsors
Funding source category [1] 299739 0
University
Name [1] 299739 0
SJWRI DClinDent Research Grants, University of Otago (Fuller Scholarships in Dentistry) pending
Country [1] 299739 0
New Zealand
Primary sponsor type
University
Name
Faculty of Dentistry, University of Otago
Address
Department of Oral Diagnostic and Surgical Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 299085 0
None
Name [1] 299085 0
Address [1] 299085 0
Country [1] 299085 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300629 0
Health and Disability Ethics Committees
Ethics committee address [1] 300629 0
Ethics committee country [1] 300629 0
New Zealand
Date submitted for ethics approval [1] 300629 0
27/06/2018
Approval date [1] 300629 0
02/11/2018
Ethics approval number [1] 300629 0
18/STH/139

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2765 2765 0 0
/AnzctrAttachments/375304-Yen Je (Jessica) Lee - Maori Consultation.pdf (Supplementary information)
Attachments [2] 3144 3144 0 0
/AnzctrAttachments/375304-Participant information sheet and consent form v2.docx (Participant information/consent)
Attachments [3] 3145 3145 0 0
/AnzctrAttachments/375304-RESEARCH PROPOSAL - HDEC v2.docx (Protocol)

Contacts
Principal investigator
Name 84274 0
Dr Yen Je (Jessica) Lee
Address 84274 0
Department of Oral Diagnostic and Surgical Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country 84274 0
New Zealand
Phone 84274 0
+64 3 479 7023
Fax 84274 0
Email 84274 0
[email protected]
Contact person for public queries
Name 84275 0
Yen Je (Jessica) Lee
Address 84275 0
Department of Oral Diagnostic and Surgical Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country 84275 0
New Zealand
Phone 84275 0
+64 3 479 7023
Fax 84275 0
Email 84275 0
[email protected]
Contact person for scientific queries
Name 84276 0
Yen Je (Jessica) Lee
Address 84276 0
Department of Oral Diagnostic and Surgical Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country 84276 0
New Zealand
Phone 84276 0
+64 3 479 7023
Fax 84276 0
Email 84276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
This proposed study is to be undertaken as part of an Oral Surgery Doctorate degree at the University of Otago. The principal researcher is willing to share individual participant data, however, this will be governed as per University of Otago policy on research.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.