Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively (PHEDOPO)

NCT ID: NCT05405088

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-06-26

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).

Conditions

Pain, Postoperative; Anxiety, Dental

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Open-label cohort, with short follow-up

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.

Group Type: OTHER

Questionnaires

Intervention Type: OTHER

Pain Sensitive Questionnaire (PSQ) Corah's Dental Anxiety Scale (CDAS) Pain Catastrophizing Scale (PCS) Gender Eye color Hair color Blood group

Interventions

Questionnaires

Pain Sensitive Questionnaire (PSQ) Corah's Dental Anxiety Scale (CDAS) Pain Catastrophizing Scale (PCS) Gender Eye color Hair color Blood group

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Devoize

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2021-A02885-36

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2021 DEVOIZE 2

Identifier Type: -

Identifier Source: org_study_id