Postoperative Course Following Wisdom Tooth Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Ullevaal University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00921479
First received: June 9, 2009
Last updated: March 2, 2010
Last verified: March 2010
  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

Resource links provided by NLM:


Further study details as provided by Ullevaal 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: 100
Study Start Date: June 2005
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (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
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         
Tannestetisk Senter AS Recruiting
Oslo, Norway, NO-0257
Contact: Olaug Egeland, DDS    004722441535    bygdoy_alle@tannleger.com   
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: Professor Lasse A. Skoglund, Section of Dental Pharmacology and Pharmacotherapy, University of Oslo
ClinicalTrials.gov Identifier: NCT00921479     History of Changes
Other Study ID Numbers: OE-001
Study First Received: June 9, 2009
Last Updated: March 2, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014