Primary Objective: To investigate the clinical symptoms including pain response after third molar (i.e. wisdom teeth, or short: M3) extraction in relation to biomarkers and preoperative pain profile of individual subjects Secondary Objective: To…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Interpatient pain response on NRS, biomarkers and genetic profile.
Secondary outcome
n.a.
Background summary
Postoperative pain response after surgical extraction of (wisdom) teeth may
vary among patients. In identical surgical procedures, it has been observed
that patient responses and severity of symptoms vary. Some have no
postoperative pain, others have severe pain. Little is know to explain these
variety in responses.
Study objective
Primary Objective: To investigate the clinical symptoms including pain response
after third molar (i.e. wisdom teeth, or short: M3) extraction in relation to
biomarkers and preoperative pain profile of individual subjects
Secondary Objective: To investigate the genetic profile of subjects with
postoperative pain undergoing M3 extraction (exploratory purposes only)
Study design
This exploratory study will be performed in patients already scheduled for M3
extraction at the Department of Oral Maxillofacial Surgery of the University
Medical Centre Groningen (UMCG). After the patients have given their consent
to the study they will be interviewed, including pain rating with the Numeric
Rating Scale (0-10). The scheduled extraction is executed and a drain is placed
in the extraction cavities for collection of post-operative wound fluid and a
blood sample to be used for genetic testing. Post-operative questionnaire
taking, including NRS pain rating and wound fluid sampling will take place
directly after M3 extraction, 30 min, 1h and 2 h post-extraction. Blood samples
are taken direct after the extraction and two hours post-extraction. After the
last questionnaire, the drain is removed. The patients are asked to fill in a
dairy for a period of 4 days at home that includes a questionnaire, NRS pain
rating and medication taken. After 1 week the patient returns for follow-up
interview and returns the dairy.
Study burden and risks
• Postsurgery waiting time of 2 hours
• Wound catheter in situ during 2 hours
• Filling in questionnaires and diary during four days
• One extra visit to the department of Oral Surgery
• Four wound fluid samples and two blood samples
• Neglible risks and minimal burden
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Healthy subjects with age between 18 and 45 and BMI between 20 and 27 kg/m2 at screening
Exclusion criteria
Clinically significant acute illness within 7 days prior to study procedure.
Anti blood clotting medication
Donation of 1 or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 90 days prior to study procedure.
Has received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
Allergy to standard rescue medication Ibuprofen.
History of gastro-intestinal disturbances (gastropathy)
Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43419.042.13 |