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Postoperative Course Following Wisdom Tooth Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Oslo University Hospital
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Lasse Ansgar Skoglund, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00921479
First received: June 9, 2009
Last updated: March 29, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to determine how quality of life changes after surgical removal of wisdom teeth

Condition
Pain, Postoperative

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Course and Quality of Life Following Surgical Removal of the Mandibular 3. Molar

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Oral Health Impact Profile (OHIP-14) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Intensity (0-10 Numerical Rating Scale) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Norwegian McGill Pain Questionnaire (NMPQ) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Subjective Swelling Assessment (0-10 Numerical rating Scale) [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
  • Corahs Dental Anxiety Scale (CDAS) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2005
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Females
Norwegian females Caucasian origin, between the age of 18 and 45, who are candidates for surgical removal of one mandibular 3. molar.
Males
Norwegian males of Caucasian origin, between the age of 18 and 45, who are candidates for surgical removal of one mandibular 3. molar

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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Norwegian outpatients patients of Caucasian origin operated in a primary care clinic
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.
  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: NCT00921479

Locations
Norway
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital Recruiting
Oslo, Norway, NO-0407
Contact: Lasse A Skoglund, DDS, DSci    004722844672    lasses@odont.uio.no   
Contact: Per Skjelbred, MD, DDS, PhD    004722118484    p.skjelbred@ulleval.no   
Sub-Investigator: Olaug Egeland, DDS         
Principal Investigator: Lasse A Skoglund, DDS, DSci         
Department of Oral and Maxillofacial Surgery, OUS Recruiting
Oslo, Norway, NO-0424
Contact: Lasse A Skoglund, DDS, DSci    004722844672    lasses@odont.uio.no   
Contact: Ellen C Vigen, MOdont    004722844671    ellencv@odont.uio.no   
Sponsors and Collaborators
Ullevaal University Hospital
University of Oslo
Investigators
Principal Investigator: Lasse A Skoglund, DDS, DSci Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, University of Oslo
  More Information

Publications:
Responsible Party: Lasse Ansgar Skoglund, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00921479     History of Changes
Other Study ID Numbers: OE-001 
Study First Received: June 9, 2009
Last Updated: March 29, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by Oslo University Hospital:
third molar
quality of life
postoperative swelling
postoperative pain
Surgical Procedures, Operative
Postoperative Period

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on December 09, 2016