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

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ClinicalTrials.gov Identifier: NCT00805298
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : October 24, 2012
Sponsor:
Collaborator:
Tandlaegeforeningen, Calcin fonden
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE December 8, 2008
First Posted Date  ICMJE December 9, 2008
Last Update Posted Date October 24, 2012
Study Start Date  ICMJE August 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2008)
  • postoperative pain [ Time Frame: within the first week after surgery ]
  • postoperative inflammation [ Time Frame: within the first week after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2008)
  • use of analgesics [ Time Frame: within one week after surgery ]
  • absence from work [ Time Frame: within one week after surgery ]
  • trismus [ Time Frame: within one week after surgery ]
  • alveolitis (dry socket) [ Time Frame: within one week after surgery ]
  • sensory disturbance [ Time Frame: within one week after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Operative Course in Connection With Removal of Lower Third Molars
Official Title  ICMJE Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling
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.

Detailed 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Postoperative Pain
  • Inflammation
Intervention  ICMJE
  • Drug: methylprednisolone
    32 mg before surgery, 16 mg twice daily the day after surgery
    Other Name: medrol
  • Drug: placebo
    two tablets before surgery, one tablet twice daily on the day after surgery
  • Drug: xyloplyin adrenalin
    lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.
  • Drug: marcain adrenalin
    bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml
Study Arms  ICMJE
  • Active Comparator: methylprednisolone
    Intervention: Drug: methylprednisolone
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: lidocaine
    Intervention: Drug: xyloplyin adrenalin
  • Active Comparator: bupivacaine
    Intervention: Drug: marcain adrenalin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2010)
154
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2008)
148
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00805298
Other Study ID Numbers  ICMJE 2008-000866-22
01.01.08Jen
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Tandlaegeforeningen, Calcin fonden
Investigators  ICMJE
Principal Investigator: Jennifer H Christensen, DDS University of Aarhus
PRS Account University of Aarhus
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP