Postoperative Course Following Wisdom Tooth Surgery

Pain, Postoperative Clinical Trial

Official title:

Postoperative Course and Quality of Life Following Surgical Removal of the Mandibular 3. Molar

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00921479
• Other study ID #: OE-001
• Status: Recruiting
• Start date: June 2005
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine how quality of life changes after surgical removal of wisdom teeth

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Locations

Country	Name	City	State
Norway	Department of Oral and Maxillofacial Surgery, OUS	Oslo
Norway	Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (7)

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. — View Citation

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

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. — View Citation

Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5. — View Citation

Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Health Impact Profile (OHIP-14)	Measure functional status of the oral cavity	7 days
Secondary	Pain Intensity (0-10 Numerical Rating Scale)	Subjective measure pain intensity	7 days
Secondary	Norwegian McGill Pain Questionnaire (NMPQ)	Measure quantitative and qualitative pain characteristics	7 days
Secondary	Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ)	Measure qualitative and quantitative pain characetristics	7 days
Secondary	Subjective Swelling Assessment (0-10 Numerical rating Scale)	Subjective assessment of postoperative swelling	7 Days
Secondary	Corahs Dental Anxiety Scale (CDAS)	Assessment of preoperative anxiety	1 day