Assessment of the Operative Course in Connection With Removal of Lower Third Molars
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|ClinicalTrials.gov Identifier: NCT00805298|
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : October 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Inflammation||Drug: methylprednisolone Drug: placebo Drug: xyloplyin adrenalin Drug: marcain adrenalin||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||August 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
|Active Comparator: methylprednisolone||
32 mg before surgery, 16 mg twice daily the day after surgery
Other Name: medrol
|Placebo Comparator: placebo||
two tablets before surgery, one tablet twice daily on the day after surgery
|Active Comparator: lidocaine||
Drug: xyloplyin adrenalin
lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.
|Active Comparator: bupivacaine||
Drug: marcain adrenalin
bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml
- postoperative pain [ Time Frame: within the first week after surgery ]
- postoperative inflammation [ Time Frame: within the first week after surgery ]
- use of analgesics [ Time Frame: within one week after surgery ]
- absence from work [ Time Frame: within one week after surgery ]
- trismus [ Time Frame: within one week after surgery ]
- alveolitis (dry socket) [ Time Frame: within one week after surgery ]
- sensory disturbance [ Time Frame: within one week after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805298
|School of Dentistry, Aarhus University|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Jennifer H Christensen, DDS||University of Aarhus|