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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805298
• Other study ID #: 2008-000866-22
• Secondary ID: 01.01.08Jen
• Status: Completed
• Phase: N/A
• First received: December 8, 2008
• Last updated: October 23, 2012
• Start date: August 2008
• Est. completion date: November 2010

Study information

• Verified date: October 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Inflammation
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Denmark	School of Dentistry, Aarhus University	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Tandlaegeforeningen, Calcin fonden

Country where clinical trial is conducted

Denmark, 

References & Publications (24)

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. — View Citation

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. — View Citation

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. — View Citation

Bystedt H, Nordenram A. Effect of methylprednisolone on complications after removal of impacted mandibular third molars. Swed Dent J. 1985;9(2):65-9. — View Citation

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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. Epub 2006 Aug 10. — View Citation

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. — View Citation

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Micó-Llorens JM, Satorres-Nieto M, Gargallo-Albiol J, Arnabat-Domínguez J, Berini-Aytés 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. Epub 2006 Aug 11. — View Citation

Moore PA. Bupivacaine: a long-lasting local anesthetic for dentistry. Oral Surg Oral Med Oral Pathol. 1984 Oct;58(4):369-74. Review. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

Schultze-Mosgau S, Schmelzeisen R, Frölich 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. — View Citation

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. — View Citation

Skjelbred P, Løkken P. Effects of naloxone on post-operative pain and steroid-induced analgesia. Br J Clin Pharmacol. 1983 Feb;15(2):221-6. — View Citation

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UStün 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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain		within the first week after surgery	No
Primary	postoperative inflammation		within the first week after surgery	No
Secondary	use of analgesics		within one week after surgery	No
Secondary	absence from work		within one week after surgery	No
Secondary	trismus		within one week after surgery	No
Secondary	alveolitis (dry socket)		within one week after surgery	No
Secondary	sensory disturbance		within one week after surgery	No