Assessment of the Operative Course in Connection With Removal of Lower Third Molars
NCT ID: NCT00805298
Last Updated: 2012-10-24
Study Results
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Basic Information
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COMPLETED
NA
154 participants
INTERVENTIONAL
2008-08-31
2010-11-30
Brief Summary
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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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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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methylprednisolone
methylprednisolone
32 mg before surgery, 16 mg twice daily the day after surgery
placebo
placebo
two tablets before surgery, one tablet twice daily on the day after surgery
lidocaine
xyloplyin adrenalin
lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.
bupivacaine
marcain adrenalin
bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml
Interventions
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methylprednisolone
32 mg before surgery, 16 mg twice daily the day after surgery
placebo
two tablets before surgery, one tablet twice daily on the day after surgery
xyloplyin adrenalin
lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.
marcain adrenalin
bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* two impacted or semi-impacted lower third molars with indication for removal
* signed informed consent
Exclusion Criteria
* need for sedation
* pregnancy
* systemic disease besides asthma/hay fever
18 Years
ALL
Yes
Sponsors
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Tandlaegeforeningen, Calcin fonden
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Jennifer H Christensen, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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School of Dentistry, Aarhus University
Aarhus, , Denmark
Countries
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References
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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.
Bruce RA, Frederickson GC, Small GS. Age of patients and morbidity associated with mandibular third molar surgery. J Am Dent Assoc. 1980 Aug;101(2):240-5. doi: 10.14219/jada.archive.1980.0183.
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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.
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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.
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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.
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.
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.
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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.
Other Identifiers
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01.01.08Jen
Identifier Type: -
Identifier Source: secondary_id
2008-000866-22
Identifier Type: -
Identifier Source: org_study_id