None listed
Conditions
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.
Interventions
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 a
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.
Sponsors
Faculty of Dentistry, University of Otago
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
16 Years to 40 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed