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

History of Changes

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:

Coll AM, Ameen JR, Mead D. Postoperative pain assessment tools in day surgery: literature review. J Adv Nurs. 2004 Apr;46(2):124-33. Review.

Corah NL. Dental anxiety. Assessment, reduction and increasing patient satisfaction. Dent Clin North Am. 1988 Oct;32(4):779-90. Review.

Kim HS, Schwartz-Barcott D, Holter IM, Lorensen M. Developing a translation of the McGill pain questionnaire for cross-cultural comparison: an example from Norway. J Adv Nurs. 1995 Mar;21(3):421-6.

Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-7.

Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-99.

Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90.

Slade GD. Assessing change in quality of life using the Oral Health Impact Profile. Community Dent Oral Epidemiol. 1998 Feb;26(1):52-61.


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 September 30, 2016

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