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Completed

NCT Number: NCT05405088

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

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.

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Key information

Conditions

Pain, Postoperative Anxiety Disorders Anxiety, Dental Behavior Coitus Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Sexual Behavior Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

questionnaires

Other

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

Primary outcomes

  1. Postoperative pain Day 1

    Time frame: Information gathering on the morning of day 1

    The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"

  2. Postoperative pain Day 1

    Time frame: Information gathering on the evening of day 1

    The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"

  3. Postoperative pain Day 2

    Time frame: Information gathering on the morning of day 2

    The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"

  4. Postoperative pain Day 2

    Time frame: Information gathering on the evening of day 2

    The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"

  5. Postoperative pain Day 3

    Time frame: Information gathering on the morning of day 3

    The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"

  6. Postoperative pain Day 3

    Time frame: Information gathering on the evening of day 3

    The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"

  7. Postoperative pain Day 4

    Time frame: Information gathering on the morning of day 4

    The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"

  8. Postoperative pain Day 4

    Time frame: Information gathering on the evening of day 4

    The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"

  9. Postoperative pain Day 5

    Time frame: Information gathering on the morning of day 5

    The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"

  10. Postoperative pain Day 5

    Time frame: Information gathering on the evening of day 5

    The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"

Secondary outcomes

  1. Explanatory variable 1: Pain Sensitive Questionnaire

    Time frame: 1 time only before surgery

    The Pain Sensitivity Questionnaire (PSQ) is a self-administered questionnaire comprising 17 items, each rated from 0 to 10. items n° 3-6-7-10-11-12-14 evoke moderately painful situations (and their sum makes it possible to calculate a "minor" PSQ score), and items n° 1-2-4-8- 15-16-17 evoke clearly painful situations (and their sum makes it possible to calculate a "moderate" PSQ score). The sum of these two scores is the "total" PSQ score. As each response to each item ranges from 0 to 10, the minimum value for all scores is 0, and the maximal ones for the minor, the moderate and the total PSQ scores are respectively 7, 7 and 14. The higher the scores, the higher the sensitivity to pain.

  2. Explanatory variable 2: Corah's Dental Anxiety Scale (CDAS)

    Time frame: 1 time only before surgery

    Corah's Dental Anxiety Scale is based on 4 main questions and calculates a score from 5 to 20 (0-8: no anxiety; 9-12: moderate anxiety; 13-14: high anxiety; 15-20: severe anxiety)

  3. Explanatory variable 3: Pain Catastrophizing Scale (PCS)

    Time frame: 1 time only before surgery

    Pain Catastrophizing Scale is based on 13 questions that cover 3 representative domains of dramatization: exaggeration of the pain felt (magnification), the tendency to constantly meditate on the pain (rumination) and the feeling of abandonment or lack of associated support (helplessness). As each response to each of the 13 responses items ranges from 0 to 4, the minimum value for the PCS score is 0, and the maximal is 52. The higher the score, the higher the level of pain catastrophizing.

  4. Explanatory variable 4: Gender

    Time frame: 1 time only before surgery

    Gender will be determined between male or female subject

  5. Explanatory variable 5: Eye color

    Time frame: 1 time only before surgery

    The color of the iris will be determined by the scale of Martine and Schultz:

    Light tones:

    1-2: Blue 3: Blue gray 4: Gray 5: Blue-gray with yellow/brown spots 6: Grey-green with yellow/brown spots 7: Green 8: Green with yellow/brown spots 9-10-11: Light brown or hazelnut brown

    Dark tones:

    12-13: Brown 14-15: Dark brown to black

  6. Explanatory variable 6: Hair color

    Time frame: 1 time only before surgery

    Hair color will be determined by color:

    Black Brown Blond Red

  7. Explanatory variable 7: Blood group

    Time frame: 1 time only before surgery

    The blood group will be determined by the groups:

    O HAS B AB as well as Rhesus + or -

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: PHEDOPO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2022
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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