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| Sponsors and Collaborators: |
University of Aarhus Tandlaegeforeningen, Calcin fonden |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00805298 |
Purpose
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 | Intervention |
|---|---|
|
Postoperative Pain Inflammation |
Drug: methylprednisolone Drug: placebo Drug: xyloplyin adrenalin Drug: marcain adrenalin |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 148 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| methylprednisolone: Active Comparator |
Drug: methylprednisolone
32 mg before surgery, 16 mg twice daily the day after surgery
|
| placebo: Placebo Comparator |
Drug: placebo
two tablets before surgery, one tablet twice daily on the day after surgery
|
| lidocaine: Active Comparator |
Drug: xyloplyin adrenalin
lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.
|
| bupivacaine: Active Comparator |
Drug: marcain adrenalin
bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jennifer H Christensen, DDS | +45 8942 4056 | jennifer.heather.christensen@odontologi.au.dk |
| Contact: Søren Schou, DDS, dr. odont | +45 8942 4133 | sschou@odont.au.dk |
| Denmark | |
| School of Dentistry, Aarhus University | Recruiting |
| Aarhus, Denmark, 8000 | |
| Contact: Jennifer H Christensen, DDS +45 8942 4056 jennifer.heather.christensen@odontologi.au.dk | |
| Contact: Søren Schou, DDS, Dr. odont +45 8942 4133 sschou@odont.au.dk | |
| Principal Investigator: | Jennifer H Christensen, DDS | Aarhus University |
More Information
| Responsible Party: | School of Dentistry, Aarhius University ( Søren Schou, dr. odont ) |
| Study ID Numbers: | 2008-000866-22, 01.01.08Jen |
| Study First Received: | December 8, 2008 |
| Last Updated: | December 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00805298 History of Changes |
| Health Authority: | Denmark: Ethics Committee; Denmark: Danish Medicines Agency |
|
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 |
|
Anti-Inflammatory Agents Neurotransmitter Agents Adrenergic Agents Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Anesthetics Edema Prednisolone acetate Pain Hormones Neuroprotective Agents Adrenergic Agonists Signs and Symptoms |
Vasoconstrictor Agents Epinephrine Pain, Postoperative Methylprednisolone Hemisuccinate Adrenergic alpha-Agonists Antineoplastic Agents, Hormonal Adrenergic beta-Agonists Lidocaine Central Nervous System Depressants Anti-Asthmatic Agents Methylprednisolone acetate Cardiovascular Agents Glucocorticoids Anesthetics, Local Inflammation |
|
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Anesthetics Prednisolone acetate Pain Hormones Neuroprotective Agents |
Adrenergic Agonists Signs and Symptoms Pathologic Processes Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Epinephrine Pain, Postoperative Methylprednisolone Hemisuccinate Adrenergic alpha-Agonists Antineoplastic Agents, Hormonal Adrenergic beta-Agonists Sympathomimetics Gastrointestinal Agents Central Nervous System Depressants |
