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Postoperative Course Following Wisdom Tooth Surgery

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ClinicalTrials.gov Identifier: NCT00921479
Recruitment Status : Recruiting
First Posted : June 16, 2009
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease
Pain, Postoperative

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.

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Course and Quality of Life Following Surgical Removal of the Mandibular 3. Molar
Study Start Date : June 2005
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Oral Health Impact Profile (OHIP-14) [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Pain Intensity (0-10 Numerical Rating Scale) [ Time Frame: 7 days ]
  2. Norwegian McGill Pain Questionnaire (NMPQ) [ Time Frame: 7 days ]
  3. Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ) [ Time Frame: 7 days ]
  4. Subjective Swelling Assessment (0-10 Numerical rating Scale) [ Time Frame: 7 Days ]
  5. Corahs Dental Anxiety Scale (CDAS) [ Time Frame: 1 day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lasse Ansgar Skoglund, 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