Clinical trial NCT00921479: Postoperative Course Following Wisdom Tooth Surgery
Official title: Postoperative Course and Quality of Life Following Surgical Removal of the Mandibular 3. Molar
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Postoperative
Keywords: third molar
quality of life
postoperative swelling
postoperative pain
Surgical Procedures, Operative
Postoperative Period
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2009-06-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Norwegian outpatients patients of Caucasian origin operated in a primary care clinic

Brief summary: The purpose of this study is to determine how quality of life changes after surgical removal of wisdom teeth

Detailed description: A significant percentage of patients are subjected to surgical removal of 3. molars every year. The surgical mucosal and osseous procedure may lead to postoperative discomfort including pain, for the patient. Information with respect to how patients regard the impact of this surgical treatment on oral health including pain and swelling is of great interest. More precise information about the postoperative course following this surgery will be beneficial in improving clinical treatment procedures with respect to alleviating the patients' postoperative period.

Eligibility criteria: Inclusion Criteria:

* Patients of either sex of Caucasian origin, between the age of 18 and 45, who are candidates for surgical removal of one mandibular 3. molar

Exclusion Criteria:

* Chronic drug treatment (except birth control medication) with analgesics, anti-inflammatory treatment (both steroidal (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs)) apart from standard postoperative analgesic treatment administered by the operator.
* The necessity for anti-microbial drugs.
* Pregnant or lactating women.
* Patients with diabetes.
* Patients who due to age or communication skills are considered unable to complete patient forms.
* Professional evaluation suggests an alteration of the planned surgical area or treatment form.
* Surgery exceeding 45 minutes, from time of first incision to completed suturing.
* Known or assumed intolerance or hypersensibility to ibuprofen (standard postoperative analgesic treatment).
* Known or assumed intolerance or hypersensibility to the standard local anaesthetic Xylocain-adrenalin (lidocaine-adrenalin).
* Consumption of alcohol in the period from 2 days before or until the end of the primary observation period (postoperative days 0-7.

Primary outcomes:
measure: Oral Health Impact Profile (OHIP-14)
timeFrame: 7 days
Secondary outcomes:
measure: Pain Intensity (0-10 Numerical Rating Scale)
timeFrame: 7 days
measure: Norwegian McGill Pain Questionnaire (NMPQ)
timeFrame: 7 days
measure: Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ)
timeFrame: 7 days
measure: Subjective Swelling Assessment (0-10 Numerical rating Scale)
timeFrame: 7 Days
measure: Corahs Dental Anxiety Scale (CDAS)
timeFrame: 1 day
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
city: Oslo
country: Norway
facility: Department of Oral and Maxillofacial Surgery, OUS
Study officials:
affiliation: Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, University of Oslo
name: Lasse A Skoglund, DDS, DSci
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Slade GD. Assessing change in quality of life using the Oral Health Impact Profile. Community Dent Oral Epidemiol. 1998 Feb;26(1):52-61. doi: 10.1111/j.1600-0528.1998.tb02084.x.