Assessment of the Operative Course in Connection With Removal of Lower Third Molars

Study Overview
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Brief Summary
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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
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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

Official Title
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Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling

Conditions
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Postoperative Pain, Inflammation

Intervention / Treatment
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* Drug: methylprednisolone
* Drug: placebo
* Drug: xyloplyin adrenalin
* Drug: marcain adrenalin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: methylprednisolone<br> | Drug: methylprednisolone<br>* 32 mg before surgery, 16 mg twice daily the day after surgery<br>* Other names: medrol;|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* two tablets before surgery, one tablet twice daily on the day after surgery<br>|
| Active Comparator: lidocaine<br> | Drug: xyloplyin adrenalin<br>* lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.<br>|
| Active Comparator: bupivacaine<br> | Drug: marcain adrenalin<br>* bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | within the first week after surgery | 
| postoperative inflammation |  | within the first week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of analgesics |  | within one week after surgery | 
| absence from work |  | within one week after surgery | 
| trismus |  | within one week after surgery | 
| alveolitis (dry socket) |  | within one week after surgery | 
| sensory disturbance |  | within one week after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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