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Trial registered on ANZCTR


Registration number
ACTRN12617001203347
Ethics application status
Approved
Date submitted
10/08/2017
Date registered
17/08/2017
Date last updated
17/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Routes of Dexamethasone Administration during Wisdom Teeth Removal
Scientific title
The use of Dexamethasone to reduce adverse post-operative effects of wisdom teeth surgery: A comparison of two routes of administration.
Secondary ID [1] 292635 0
None
Universal Trial Number (UTN)
U1111-1197-8988
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impacted Wisdom Teeth 304360 0
Swelling, pain and soscial isolation after wisdom teeth surgery 304361 0
Condition category
Condition code
Oral and Gastrointestinal 303697 303697 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 303742 303742 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive 8mg of submucosal (injection into the gums next to the wisdom teeth) dexamethasone. This will be administered immediately following intravenous sedation and local anaesthesia. The preparation of dexamethasone will be done by a registered hospital pharmacist, and it will be administered by the operator (Dental Surgeon) under the supervision of one of my clinical supervisors (Mr Rohana De Silva; Mr Harsha De Silva; Professor Darryl Tong. All three supervisors are qualified Oral and Maxillofacial Surgeon Consultants.
Intervention code [1] 298869 0
Treatment: Surgery
Intervention code [2] 298887 0
Treatment: Drugs
Comparator / control treatment
The control group will receive 8mg of dexamethasone via the intravenous route (current practice adopted by the faculty), administered immediately folllowing intravenous sedation and local anaesthesia.
Control group
Active

Outcomes
Primary outcome [1] 303059 0
Facial Swelling. The amount of facial swelling will be made using a 3-dimensional facial photography system (3dMD.trio system).
Timepoint [1] 303059 0
Post-operatively day 2 and day 7.
Primary outcome [2] 303090 0
Amount of pain experienced.
Post-operative pain analysis will be conducted with the help of a 100mm visual analogue scale (VAS).
Timepoint [2] 303090 0
Post-operatively day 2 and day 7.
Primary outcome [3] 303091 0
Measurement of trismus
Trismus will be calculated with interincisal mouth opening, measured with a caliper.
Timepoint [3] 303091 0
Post-operatively day 2 and day 7.
Secondary outcome [1] 337796 0
Measurement of patient satisfaction using Quality of life questionnaires.
The 2 questionnaires used are the Health Related Quality of Life (HRQOL), and the OHIP-14. These questionnaires will involve different items addressing social isolation, working isolation, eating ability and diet variations, speaking ability, sleep impairment and physical appearance. The validity of the these questionnaire has been demonstrated in a previous study by its ability to discriminate between different groups of patients and its good correlation with the objectively measured variables.
Timepoint [1] 337796 0
HRQOL will be completed everyday from Day 1 to Day 7 as a daily diary.
OHIP-14 will be completed at post-operative Day 2 and Day 7.

Eligibility
Key inclusion criteria
Participants (ASA 1 or 2) will be recruited from the pool of patients who were either self-referred or referred by a dental or medical practitioner to the Oral Surgery department, Faculty of Dentistry, University of Otago, for the surgical removal of at least two impacted mandibular third molars.
Minimum age
16 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anyone with one of more of the following:
a. Diabetes
b. Immunosuppressive medications
c. Non-steroidal anti-inflammatory (NSAID e.g. Neurofen, Voltaren) drug-induced asthma.
d. Stomach or intestinal bleeding or ulceration
e. Bleeding disorder
f. Patients on blood thinners (anticoagulants)
g. Kidney impairment
h. Liver impairment
i. Cardiovascular disease
j. Systemic Lupus Erythematosus
k. Scleroderma
l. Schizophrenia
m. Epilepsy
n. Glaucoma or papilloedema
o. Pregnancy or lactation
p. Lactose intolerance
q. Respiratory depression
r. COPD
s. Raised intracranial pressure
t. Alcoholism
u. Opioid addiction
v. Patients on central nervous system depressants
w. G6PD deficiency
x. Hypersensitivity to morphine
y. Phenylketonuria
2) Patients who cannot have midazolam, paracetamol or ibuprofen.
3) Patients who cannot have either intravenous sedation.
4) Patients who are unable to give informed consent.
5) Patients who refuse involvement in the study and/or are unable to attend follow-up appointments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9143 0
New Zealand
State/province [1] 9143 0
Otago

Funding & Sponsors
Funding source category [1] 297264 0
Charities/Societies/Foundations
Name [1] 297264 0
New Zealand Dental Association Research Fund
Address [1] 297264 0
NZDA House
Building 1, 195 Main Highway
Ellerslie, Auckland 1051
Country [1] 297264 0
New Zealand
Primary sponsor type
University
Name
Faculty of Dentistry, University of Otago
Address
310 Great King Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 296237 0
None
Name [1] 296237 0
Address [1] 296237 0
Country [1] 296237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298381 0
Health and Disability Ethics Committee
Ethics committee address [1] 298381 0
Health and Disability Ethics Committee
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 298381 0
New Zealand
Date submitted for ethics approval [1] 298381 0
26/06/2017
Approval date [1] 298381 0
14/07/2017
Ethics approval number [1] 298381 0
17/NTB/127

Summary
Brief summary
Facial swelling, pain and restriction of mouth opening are common outcomes experienced by patients after the surgical removal of impacted third molars. This translates to a decrease in quality of life, especially in the first 5-7 days. Dexamethasone is a steroid injection that is used routinely in the removal of wisdom teeth to help prevent swelling. However, it is not known whether this is better administered intravenously or submucosally. The aim of our study is to compare the amount of swelling and pain with Dexamethasone administered via these two different routes. In this study, participants between the ages of 16-40 years of age requiring the surgical removal of at least 2 impacted mandibular third molars will be included. These participants will be randomly divided into two groups – A intervention group receiving 8mg of dexamethasone via the submucosal route; a control group receiving 8mg of dexamethasone via the intravenous route. A baseline measurement of facial profile and maximum mouth opening will be taken at the consultation appointment. Facial swelling will be measured using a three-dimensional non-invasive facial camera. Maximum mouth opening will be measured using a linear ruler measuring the distance between the maxillary and mandibular central incisors. Once consent is obtained, the patients will be operated under local anaesthesia and intravenous sedation. Patients will be recalled on day 2 and day 7 post- operatively to examine the amount of facial swelling, pain and restriction of mouth opening. A self-reported oral health quality of life survey will also be filled out by patients during the review appointment as an indication of the degree of social isolation, days off-work, and a measure of their quality of life as a result of swelling, pain and/or limitation in mouth opening.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76898 0
Ms Adelyn Lau
Address 76898 0
Department of Oral Diagnostics and Surgical Sciences, Faculty of Dentistry, University of Otago
10 Great King Street
Dunedin 9016
Country 76898 0
New Zealand
Phone 76898 0
+64210449832
Fax 76898 0
Email 76898 0
dr.adelynlau@gmail.com
Contact person for public queries
Name 76899 0
Prof Darryl Tong
Address 76899 0
Department of Oral Diagnostics and Surgical Sciences, Faculty of Dentistry, University of Otago
10 Great King Street
Dunedin 9016
Country 76899 0
New Zealand
Phone 76899 0
+64 3 479 7023
Fax 76899 0
Email 76899 0
darryl.tong@otago.ac.nz
Contact person for scientific queries
Name 76900 0
A/Prof Rohana De Silva
Address 76900 0
Department of Oral Diagnostics and Surgical Sciences, Faculty of Dentistry, University of Otago
10 Great King Street
Dunedin 9016
Country 76900 0
New Zealand
Phone 76900 0
+64 3 479 7031
Fax 76900 0
Email 76900 0
rohana.kumara@otago.ac.nz

No data has been provided for results reporting
Summary results
Not applicable