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

NCT00805298 | Completed DMC

• 2 other identifiers: 2008-000866-2201.01.08Jen
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Inflammation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• postoperative pain

  within the first week after surgery

• postoperative inflammation

  within the first week after surgery

Secondary Outcomes (5)

• use of analgesics

  within one week after surgery

• absence from work

  within one week after surgery

• trismus

  within one week after surgery

• alveolitis (dry socket)

  within one week after surgery

• sensory disturbance

  within one week after surgery

Study Arms (4)

methylprednisolone

ACTIVE COMPARATOR

Drug: methylprednisolone

placebo

PLACEBO COMPARATOR

Drug: placebo

lidocaine

ACTIVE COMPARATOR

Drug: xyloplyin adrenalin

bupivacaine

ACTIVE COMPARATOR

Drug: marcain adrenalin

Interventions

methylprednisolone DRUG

32 mg before surgery, 16 mg twice daily the day after surgery

Also known as: medrol

methylprednisolone

placebo DRUG

two tablets before surgery, one tablet twice daily on the day after surgery

placebo

xyloplyin adrenalin DRUG

lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.

lidocaine

marcain adrenalin DRUG

bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml

bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• two impacted or semi-impacted lower third molars with indication for removal
• signed informed consent

You may not qualify if:

• allergy to study drugs or ingredients
• need for sedation
• pregnancy
• systemic disease besides asthma/hay fever

Sponsors & Collaborators

• University of Aarhus: lead
• Tandlaegeforeningen, Calcin fonden: collaborator

Study Sites (1)

School of Dentistry, Aarhus University

Aarhus, 8000, Denmark

Location

Related Publications (24)

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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.

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MeSH Terms

Conditions

Pain, Postoperative; Inflammation

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jennifer H Christensen, DDS

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

DK (1)