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

Primary Purpose

Postoperative Pain, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
methylprednisolone
placebo
xyloplyin adrenalin
marcain adrenalin
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Dentistry, Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

methylprednisolone

placebo

lidocaine

bupivacaine

Arm Description

Outcomes

Primary Outcome Measures

postoperative pain
postoperative inflammation

Secondary Outcome Measures

use of analgesics
absence from work
trismus
alveolitis (dry socket)
sensory disturbance

Full Information

First Posted
December 8, 2008
Last Updated
October 23, 2012
Sponsor
University of Aarhus
Collaborators
Tandlaegeforeningen, Calcin fonden
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1. Study Identification

Unique Protocol Identification Number
NCT00805298
Brief Title
Assessment of the Operative Course in Connection With Removal of Lower Third Molars
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Tandlaegeforeningen, Calcin fonden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
methylprednisolone
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
lidocaine
Arm Type
Active Comparator
Arm Title
bupivacaine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Other Intervention Name(s)
medrol
Intervention Description
32 mg before surgery, 16 mg twice daily the day after surgery
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
two tablets before surgery, one tablet twice daily on the day after surgery
Intervention Type
Drug
Intervention Name(s)
xyloplyin adrenalin
Intervention Description
lidocaine local anaesthetic lidocaine 20 mg/ml, adrenalin 12,5 µg/ml maximum dosage 10 ml.
Intervention Type
Drug
Intervention Name(s)
marcain adrenalin
Intervention Description
bupivacaine local anaesthetic bupivacaine 5 mg /ml, adrenaline 5 µg/ml maximum dosage 10 ml
Primary Outcome Measure Information:
Title
postoperative pain
Time Frame
within the first week after surgery
Title
postoperative inflammation
Time Frame
within the first week after surgery
Secondary Outcome Measure Information:
Title
use of analgesics
Time Frame
within one week after surgery
Title
absence from work
Time Frame
within one week after surgery
Title
trismus
Time Frame
within one week after surgery
Title
alveolitis (dry socket)
Time Frame
within one week after surgery
Title
sensory disturbance
Time Frame
within one week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer H Christensen, DDS
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry, Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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