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| ID | Type | Description | Link |
|---|---|---|---|
| 01.01.08Jen |
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| Name | Class |
|---|---|
| Tandlaegeforeningen, Calcin fonden | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylprednisolone | Active Comparator |
| |
| placebo | Placebo Comparator |
| |
| lidocaine | Active Comparator |
| |
| bupivacaine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone | Drug | 32 mg before surgery, 16 mg twice daily the day after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | within the first week after surgery | |
| postoperative inflammation | within the first week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| use of analgesics | within one week after surgery | |
| absence from work | within one week after surgery | |
| trismus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer H Christensen, DDS | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry, Aarhus University | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3457335 | Background | Beirne OR, Hollander B. The effect of methylprednisolone on pain, trismus, and swelling after removal of third molars. Oral Surg Oral Med Oral Pathol. 1986 Feb;61(2):134-8. doi: 10.1016/0030-4220(86)90173-8. | |
| 10319823 | Background | Bouloux GF, Punnia-Moorthy A. Bupivacaine versus lidocaine for third molar surgery: a double-blind, randomized, crossover study. J Oral Maxillofac Surg. 1999 May;57(5):510-4; discussion 515. doi: 10.1016/s0278-2391(99)90063-0. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| placebo | Drug | two tablets before surgery, one tablet twice daily on the day after surgery |
|
| xyloplyin adrenalin | Drug | lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml. |
|
| marcain adrenalin | Drug | bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml |
|
| within one week after surgery |
| alveolitis (dry socket) | within one week after surgery |
| sensory disturbance | within one week after surgery |
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| 3859943 | Background | Bystedt H, Nordenram A. Effect of methylprednisolone on complications after removal of impacted mandibular third molars. Swed Dent J. 1985;9(2):65-9. |
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| 8233418 | Background | Chiapasco M, De Cicco L, Marrone G. Side effects and complications associated with third molar surgery. Oral Surg Oral Med Oral Pathol. 1993 Oct;76(4):412-20. doi: 10.1016/0030-4220(93)90005-o. |
| 8628837 | Background | de Boer MP, Raghoebar GM, Stegenga B, Schoen PJ, Boering G. Complications after mandibular third molar extraction. Quintessence Int. 1995 Nov;26(11):779-84. |
| 10513866 | Background | Esen E, Tasar F, Akhan O. Determination of the anti-inflammatory effects of methylprednisolone on the sequelae of third molar surgery. J Oral Maxillofac Surg. 1999 Oct;57(10):1201-6; discussion 1206-8. doi: 10.1016/s0278-2391(99)90486-x. |
| 3304412 | Background | Holland CS. The influence of methylprednisolone on post-operative swelling following oral surgery. Br J Oral Maxillofac Surg. 1987 Aug;25(4):293-9. doi: 10.1016/0266-4356(87)90068-4. |
| 17178485 | Background | Leone M, Richard O, Antonini F, Rousseau S, Chabaane W, Guyot L, Martin C. Comparison of methylprednisolone and ketoprofen after multiple third molar extraction: a randomized controlled study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Jan;103(1):e7-9. doi: 10.1016/j.tripleo.2006.07.005. Epub 2006 Oct 6. |
| 17052624 | Background | Markovic AB, Todorovic L. Postoperative analgesia after lower third molar surgery: contribution of the use of long-acting local anesthetics, low-power laser, and diclofenac. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Nov;102(5):e4-8. doi: 10.1016/j.tripleo.2006.02.024. Epub 2006 Aug 10. |
| 9924222 | Background | Mellor DJ, Mellor AH, McAteer EM. Local anaesthetic infiltration for surgical exodontia of third molar teeth: a double-blind study comparing bupivacaine infiltration with i.v. ketorolac. Br J Anaesth. 1998 Oct;81(4):511-4. doi: 10.1093/bja/81.4.511. |
| 15846686 | Background | Mettes TG, Nienhuijs ME, van der Sanden WJ, Verdonschot EH, Plasschaert AJ. Interventions for treating asymptomatic impacted wisdom teeth in adolescents and adults. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003879. doi: 10.1002/14651858.CD003879.pub2. |
| 16902792 | Background | Mico-Llorens JM, Satorres-Nieto M, Gargallo-Albiol J, Arnabat-Dominguez J, Berini-Aytes L, Gay-Escoda C. Efficacy of methylprednisolone in controlling complications after impacted lower third molar surgical extraction. Eur J Clin Pharmacol. 2006 Sep;62(9):693-8. doi: 10.1007/s00228-006-0164-5. Epub 2006 Aug 11. |
| 6387571 | Background | Moore PA. Bupivacaine: a long-lasting local anesthetic for dentistry. Oral Surg Oral Med Oral Pathol. 1984 Oct;58(4):369-74. doi: 10.1016/0030-4220(84)90325-6. |
| 16457912 | Background | Nayyar MS, Yates C. Bupivacaine as pre-emptive analgesia in third molar surgery: Randomised controlled trial. Br J Oral Maxillofac Surg. 2006 Dec;44(6):501-3. doi: 10.1016/j.bjoms.2005.09.012. Epub 2006 Feb 2. |
| 8469535 | Background | Neal JA, Welch TB, Halliday RW. Analysis of the analgesic efficacy and cost-effective use of long-acting local anesthetics in outpatient third molar surgery. Oral Surg Oral Med Oral Pathol. 1993 Mar;75(3):283-5. doi: 10.1016/0030-4220(93)90136-r. |
| 2995624 | Background | Osborn TP, Frederickson G Jr, Small IA, Torgerson TS. A prospective study of complications related to mandibular third molar surgery. J Oral Maxillofac Surg. 1985 Oct;43(10):767-9. doi: 10.1016/0278-2391(85)90331-3. |
| 15620767 | Background | Renton T, Hankins M, Sproate C, McGurk M. A randomised controlled clinical trial to compare the incidence of injury to the inferior alveolar nerve as a result of coronectomy and removal of mandibular third molars. Br J Oral Maxillofac Surg. 2005 Feb;43(1):7-12. doi: 10.1016/j.bjoms.2004.09.002. |
| 7799116 | Background | Schultze-Mosgau S, Schmelzeisen R, Frolich JC, Schmele H. Use of ibuprofen and methylprednisolone for the prevention of pain and swelling after removal of impacted third molars. J Oral Maxillofac Surg. 1995 Jan;53(1):2-7; discussion 7-8. doi: 10.1016/0278-2391(95)90486-7. |
| 3464711 | Background | Sisk AL, Hammer WB, Shelton DW, Joy ED Jr. Complications following removal of impacted third molars: the role of the experience of the surgeon. J Oral Maxillofac Surg. 1986 Nov;44(11):855-9. doi: 10.1016/0278-2391(86)90221-1. |
| 6849755 | Background | Skjelbred P, Lokken P. Effects of naloxone on post-operative pain and steroid-induced analgesia. Br J Clin Pharmacol. 1983 Feb;15(2):221-6. doi: 10.1111/j.1365-2125.1983.tb01489.x. |
| 10932022 | Background | Song F, O'Meara S, Wilson P, Golder S, Kleijnen J. The effectiveness and cost-effectiveness of prophylactic removal of wisdom teeth. Health Technol Assess. 2000;4(15):1-55. |
| 14600686 | Background | UStun Y, Erdogan O, Esen E, Karsli ED. Comparison of the effects of 2 doses of methylprednisolone on pain, swelling, and trismus after third molar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Nov;96(5):535-9. doi: 10.1016/S1079210403004645. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |