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

This study has been completed.
Sponsor:
Collaborator:
Tandlaegeforeningen, Calcin fonden
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00805298
First received: December 8, 2008
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Postoperative Pain
Inflammation
Drug: methylprednisolone
Drug: placebo
Drug: xyloplyin adrenalin
Drug: marcain adrenalin

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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: within the first week after surgery ] [ Designated as safety issue: No ]
  • postoperative inflammation [ Time Frame: within the first week after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • use of analgesics [ Time Frame: within one week after surgery ] [ Designated as safety issue: No ]
  • absence from work [ Time Frame: within one week after surgery ] [ Designated as safety issue: No ]
  • trismus [ Time Frame: within one week after surgery ] [ Designated as safety issue: No ]
  • alveolitis (dry socket) [ Time Frame: within one week after surgery ] [ Designated as safety issue: No ]
  • sensory disturbance [ Time Frame: within one week after surgery ] [ Designated as safety issue: No ]

Enrollment: 154
Study Start Date: August 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: methylprednisolone Drug: methylprednisolone
32 mg before surgery, 16 mg twice daily the day after surgery
Other Name: medrol
Placebo Comparator: placebo Drug: placebo
two tablets before surgery, one tablet twice daily on the day after surgery
Active Comparator: lidocaine Drug: xyloplyin adrenalin
lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.
Active Comparator: bupivacaine Drug: marcain adrenalin
bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805298

Locations
Denmark
School of Dentistry, Aarhus University
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Tandlaegeforeningen, Calcin fonden
Investigators
Principal Investigator: Jennifer H Christensen, DDS University of Aarhus
  More Information

Publications:

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00805298     History of Changes
Other Study ID Numbers: 2008-000866-22, 01.01.08Jen
Study First Received: December 8, 2008
Last Updated: October 23, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
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

Additional relevant MeSH terms:
Inflammation
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Pain
Signs and Symptoms
Epinephrine
Epinephryl borate
Methylprednisolone
Bupivacaine
Anesthetics, Local
Anesthetics
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 22, 2014