Pain, PostoperativeNCT00921479
Postoperative Course Following Wisdom Tooth Surgery
An observational study of Pain, Postoperative, run by Ullevaal University Hospital at 2 sites in Norway.
Trial summary
The purpose of this study is to determine how quality of life changes after surgical removal of wisdom teeth Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Pain, Postoperative
- How many people
- 300 participants
- Where
- 2 sitesNorway
- Study dates
- Jun 2005to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Norwegian outpatients patients of Caucasian origin operated in a primary care clinic
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 2 recruiting
- Recruiting
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
Oslo, NO-0407
Lasse A Skoglund, DDS, DSci, 004722844672, lasses@odont.uio.no
Per Skjelbred, MD, DDS, PhD, 004722118484, p.skjelbred@ulleval.no
- Recruiting
Department of Oral and Maxillofacial Surgery, OUS
Oslo, NO-0424
Lasse A Skoglund, DDS, DSci, 004722844672, lasses@odont.uio.no
Ellen C Vigen, MOdont, 004722844671, ellencv@odont.uio.no
About this study
Official title: Postoperative Course and Quality of Life Following Surgical Removal of the Mandibular 3. Molar
The purpose of this study is to determine how quality of life changes after surgical removal of wisdom teeth
Read the 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.
- Conditions
- Pain, Postoperative
- Keywords
- third molar, quality of life, postoperative swelling, postoperative pain, Surgical Procedures, Operative, Postoperative Period
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health Impact Profile (OHIP-14)
Measure functional status of the oral cavity
Measured: 7 days
Secondary outcomes (5)
Pain Intensity (0-10 Numerical Rating Scale)
Subjective measure pain intensity
Measured: 7 days
Norwegian McGill Pain Questionnaire (NMPQ)
Measure quantitative and qualitative pain characteristics
Measured: 7 days
Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ)
Measure qualitative and quantitative pain characetristics
Measured: 7 days
Subjective Swelling Assessment (0-10 Numerical rating Scale)
Subjective assessment of postoperative swelling
Measured: 7 Days
Corahs Dental Anxiety Scale (CDAS)
Assessment of preoperative anxiety
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startJun 2005
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Lasse Ansgar Skoglund, Oslo University Hospital
- Investigators
- Lasse A Skoglund, DDS, DSci, Principal investigator, Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921479
- Sponsor's protocol ID
- OE-001
- Status last verified
- Nov 2021
- First submitted
- 9 Jun 2009
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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. doi: 10.1111/j.1365-2648.2003.02972.x.
PubMed 15056325Corah NL. Dental anxiety. Assessment, reduction and increasing patient satisfaction. Dent Clin North Am. 1988 Oct;32(4):779-90.
PubMed 3053270Kim 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. doi: 10.1111/j.1365-2648.1995.tb02722.x.
PubMed 7745193Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
PubMed 3670870Melzack 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.
PubMed 1235985Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
PubMed 9332805Slade GD. Assessing change in quality of life using the Oral Health Impact Profile. Community Dent Oral Epidemiol. 1998 Feb;26(1):52-61. doi: 10.1111/j.1600-0528.1998.tb02084.x.
PubMed 9511843
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Course and Quality of Life Following Surgical Removal of the Mandibular 3. Molar
- ClinicalTrials.gov ID
- NCT00921479
- Acronym / sponsor ID
- OE-001
- Conditions
- Pain, Postoperative
- Keywords
- third molar, quality of life, postoperative swelling, postoperative pain, Surgical Procedures, Operative, Postoperative Period
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Jun 2005
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how quality of life changes after surgical removal of wisdom teeth
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Norwegian outpatients patients of Caucasian origin operated in a primary care clinic
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral Health Impact Profile (OHIP-14)
Time frame: 7 days
Measure functional status of the oral cavity
5 secondary outcomes
Pain Intensity (0-10 Numerical Rating Scale)
Time frame: 7 days
Norwegian McGill Pain Questionnaire (NMPQ)
Time frame: 7 days
Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ)
Time frame: 7 days
Subjective Swelling Assessment (0-10 Numerical rating Scale)
Time frame: 7 Days
Corahs Dental Anxiety Scale (CDAS)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Background: PubMed 15056325Coll AM, Ameen JR, Mead D. Postoperative pain assessment tools in day surgery: literature review. J Adv Nurs. 2004 Apr;46(2):124-33. doi: 10.1111/j.1365-2648.2003.02972.x.
- Background: PubMed 3053270Corah NL. Dental anxiety. Assessment, reduction and increasing patient satisfaction. Dent Clin North Am. 1988 Oct;32(4):779-90.
- Background: PubMed 7745193Kim 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. doi: 10.1111/j.1365-2648.1995.tb02722.x.
- Background: PubMed 3670870Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- Background: PubMed 1235985Melzack 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.
- Background: PubMed 9332805Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
- Background: PubMed 9511843Slade GD. Assessing change in quality of life using the Oral Health Impact Profile. Community Dent Oral Epidemiol. 1998 Feb;26(1):52-61. doi: 10.1111/j.1600-0528.1998.tb02084.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
Oslo, Norway
Lasse A Skoglund, DDS, DSci principal investigator
Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, University of Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Ullevaal University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health Impact Profile (OHIP-14) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00921479, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.