Postoperative Course Following Wisdom Tooth Surgery

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	June 16, 2009
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