Clinical trial NCT00805298: Assessment of the Operative Course in Connection With Removal of Lower Third Molars
Official title: Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Inflammation
Keywords: third molar
postoperative pain
thermography
postoperative inflammation
methylprednisolone
local anaesthetic
postoperative pain after removal of lower third molars
inflammation after removal of lower third molars
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Tandlaegeforeningen, Calcin fonden
First posted: 2008-12-09
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare postoperative complications after removal of lower third molars using two different types of anaesthetics and two different treatments against swelling and inflammation (methylprednisolone and placebo). The hypothesis is that a combination of a long-duration anaesthetic combined methylprednisolone will result in significantly less postoperative pain and inflammation.

Patients will have both lower third molars removed on two separate occasions. Each patient is randomly assigned to receive one type of local anaesthetic the first time and the other type the second time. Furthermore patients are randomised to receive either methylprednisolone or placebo the first time and the opposite treatment the second time.

During the week after surgery patients fill out a questionnaire with questions about level of pain and swelling at different times as well as the patients' perception of other postoperative complications. The patient is examined by a dentist on the 2nd and 7th day after surgery, where postoperative complications are recorded and thermographic images of the patient's face are taken to assess the degree of inflammation.

Detailed description: Background: After removal of lower third molars complications can occur, including pain, swelling, infection and sensory disturbances. As pain intensity has been shown to be worst during the first 4-8 hours post surgery, it might be relevant to use a local anaesthetic with long duration, e.g. bupivacaine, instead of the traditionally used lidocaine. Several studies have focussed on the effect of non-steroid anti-inflammatory drugs (such as glucocorticoids, e.g. methylprednisolone) to reduce postoperative swelling. However, no studies comparing the effect of bupivacaine combined with methylprednisolone and lidocaine combined with methylprednisolone have been conducted.

Aim: To compare postoperative complications after removal of lower third molars using 1) lidocaine, 2) lidocaine combined with methylprednisolone, 3) bupivacaine and 4) bupivacaine combined with methylprednisolone.

Methods: The study compares type end extension of postoperative complications after removal of lower third molars using four different combinations of local anaesthetics and anti-inflammatory treatment. The study is conducted as a double blinded, split mouth crossover trial, where each patient has both lower third molars removed at two different occasions.

Patients are randomised to receive one type of local anaesthetic the first time and the other type the second time. Furthermore patients are randomised to receive either methylprednisolone or placebo the first time and the opposite treatment the second time.

An objective assessment of postoperative swelling and inflammation is made by means of thermographic imaging of the operated side compared to the opposite side after the operation and at 2 and 7 days post surgery.

Each patient fills out a questionnaire, where the patients' perception of pain, swelling and other complications is registered. Furthermore, complications are recorded objectively by a dentist at the 2- and 7-day post-surgery visits

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* two impacted or semi-impacted lower third molars with indication for removal
* signed informed consent

Exclusion Criteria:

* allergy to study drugs or ingredients
* need for sedation
* pregnancy
* systemic disease besides asthma/hay fever

Primary outcomes:
measure: postoperative pain
timeFrame: within the first week after surgery
measure: postoperative inflammation
timeFrame: within the first week after surgery
Secondary outcomes:
measure: use of analgesics
timeFrame: within one week after surgery
measure: absence from work
timeFrame: within one week after surgery
measure: trismus
timeFrame: within one week after surgery
measure: alveolitis (dry socket)
timeFrame: within one week after surgery
measure: sensory disturbance
timeFrame: within one week after surgery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: School of Dentistry, Aarhus University
Study officials:
affiliation: University of Aarhus
name: Jennifer H Christensen, DDS
role: PRINCIPAL_INVESTIGATOR
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