ANZCTR - Registration

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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]

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

Swelling, pain and soscial isolation after wisdom teeth surgery

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Surgery

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]

Treatment: Surgery

Intervention code [2]

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]

Facial Swelling. The amount of facial swelling will be made using a 3-dimensional facial photography system (3dMD.trio system).

Timepoint [1]

Post-operatively day 2 and day 7.

Primary outcome [2]

Amount of pain experienced.
Post-operative pain analysis will be conducted with the help of a 100mm visual analogue scale (VAS).

Timepoint [2]

Post-operatively day 2 and day 7.

Primary outcome [3]

Measurement of trismus
Trismus will be calculated with interincisal mouth opening, measured with a caliper.

Timepoint [3]

Post-operatively day 2 and day 7.

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

21/08/2017

Actual

Date of last participant enrolment

Anticipated

21/12/2020

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

130

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

New Zealand Dental Association Research Fund

Address [1]

NZDA House
Building 1, 195 Main Highway
Ellerslie, Auckland 1051

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Health and Disability Ethics Committee
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

26/06/2017

Approval date [1]

14/07/2017

Ethics approval number [1]

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

Ms Adelyn Lau

Address

Department of Oral Diagnostics and Surgical Sciences, Faculty of Dentistry, University of Otago
10 Great King Street
Dunedin 9016

Country

New Zealand

Phone

+64210449832

Fax

dr.adelynlau@gmail.com

Contact person for public queries

Name

Darryl Tong

Address

Department of Oral Diagnostics and Surgical Sciences, Faculty of Dentistry, University of Otago
10 Great King Street
Dunedin 9016

Country

New Zealand

Phone

+64 3 479 7023

Fax

darryl.tong@otago.ac.nz

Contact person for scientific queries

Name

Rohana De Silva

Address

Department of Oral Diagnostics and Surgical Sciences, Faculty of Dentistry, University of Otago
10 Great King Street
Dunedin 9016

Country

New Zealand

Phone

+64 3 479 7031

Fax

rohana.kumara@otago.ac.nz

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Third Molar Surgery Outcomes: A Randomized Clinical Trial Comparing Submucosal and Intravenous Dexamethasone.	2021	https://dx.doi.org/10.1016/j.joms.2020.09.020

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically