Clinical trial NCT05405088: Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively (PHEDOPO)
Official title: Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Anxiety, Dental
Keywords: Pain
Oral surgery
Postoperative
Gender
Eye color
Blood group
Hair color
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a collection of data from postoperative questionnaires and simple, non-invasive clinical observations. The oral surgery acts in question are performed in daily practice without any change in patient management. The intraoperative data collected come from routine care. Postoperative data (pain and analgesic intake) are collected by self-questionnaires and no visit on purpose is required.
Primary purpose: SCREENING

Brief summary: This project aims to study various predictive factors of postoperative pain after oral surgery among different parameters accessible preoperatively, in order to build a predictive model. It also aims to validate the external consistency of the Pain Sensitivity Questionnaire in an odontological context.

Detailed description: This project aims to study various predictive factors of postoperative pain after oral surgery among different phenotypic parameters accessible to preoperative interrogation (anxiety about dental care, personal perception of pain sensitivity, gender, eye color, hair color, blood group) in order to build a predictive model. It also aims to validate the external consistency of the Pain Sensitivity Questionnaire (PSQ) in an odontological context, by studying the relationship between the personal perception of pain sensitivity (measured by the PSQ) and anxiety about dental care (measured by the Corah Dental Anxiety Scale), as well as dramatization in the face of pain (measured by the Pain Catastrophizing Scale).

Eligibility criteria: Inclusion Criteria:

* Adult patient, male or female, eligible for dental extraction under local anesthesia,

  * either a tooth on the arch,
  * either wisdom tooth(s) (2 homolateral wisdom teeth (maxilla + mandibular) or a mandibular wisdom tooth).
* Fluent in speaking and reading French.
* Able to give informed consent to research.
* Affiliation to a Social Security scheme.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Contraindication to paracetamol, NSAIDs, tramadol, or anesthetic agents local.
* Patient uncooperative, unlikely or unable to comply with all procedures of the protocol.
* Chronic use of opiates, in a therapeutic or illicit context.
* Chronic depression on long-term antidepressants.
* Stomatological pathology that may interfere with the conduct of the intervention or modify the results: insufficient mouth opening, pathologies of the temporal mandibular joints ...
* Active medical pathology, or any medical condition judged by the investigator to be incompatible with the study.
* Patient under guardianship, curatorship or safeguard of justice.
* Refusal to participate.

Primary outcomes:
measure: Postoperative pain Day 1
timeFrame: Information gathering on the morning of day 1
measure: Postoperative pain Day 1
timeFrame: Information gathering on the evening of day 1
measure: Postoperative pain Day 2
timeFrame: Information gathering on the morning of day 2
measure: Postoperative pain Day 2
timeFrame: Information gathering on the evening of day 2
measure: Postoperative pain Day 3
timeFrame: Information gathering on the morning of day 3
measure: Postoperative pain Day 3
timeFrame: Information gathering on the evening of day 3
measure: Postoperative pain Day 4
timeFrame: Information gathering on the morning of day 4
measure: Postoperative pain Day 4
timeFrame: Information gathering on the evening of day 4
measure: Postoperative pain Day 5
timeFrame: Information gathering on the morning of day 5
measure: Postoperative pain Day 5
timeFrame: Information gathering on the evening of day 5
Secondary outcomes:
measure: Explanatory variable 1: Pain Sensitive Questionnaire
timeFrame: 1 time only before surgery
measure: Explanatory variable 2: Corah's Dental Anxiety Scale (CDAS)
timeFrame: 1 time only before surgery
measure: Explanatory variable 3: Pain Catastrophizing Scale (PCS)
timeFrame: 1 time only before surgery
measure: Explanatory variable 4: Gender
timeFrame: 1 time only before surgery
measure: Explanatory variable 5: Eye color
timeFrame: 1 time only before surgery
measure: Explanatory variable 6: Hair color
timeFrame: 1 time only before surgery
measure: Explanatory variable 7: Blood group
timeFrame: 1 time only before surgery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Laurent Devoize
role: PRINCIPAL_INVESTIGATOR
References: