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Completed

NCT Number: NCT00805298

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, Aarhus University

Aarhus, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

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

Other names: medrol

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

Primary outcomes

  1. postoperative pain

    Time frame: within the first week after surgery

  2. postoperative inflammation

    Time frame: within the first week after surgery

Secondary outcomes

  1. use of analgesics

    Time frame: within one week after surgery

  2. absence from work

    Time frame: within one week after surgery

  3. trismus

    Time frame: within one week after surgery

  4. alveolitis (dry socket)

    Time frame: within one week after surgery

  5. sensory disturbance

    Time frame: within one week after surgery

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Tandlaegeforeningen, Calcin fonden

Registry information

Official study title

Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2008
Registry last updated
Oct 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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