Pain, PostoperativePHEDOPONCT05405088
Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively (PHEDOPO)
A study testing Questionnaires in people with Pain, Postoperative and Anxiety, Dental, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Anxiety, Dental
- What is being tested?
- Questionnaires
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 26 Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 ...
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively
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.
Read the 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
- Being tested
- Questionnaires
- Keywords
- Pain, Oral surgery, Postoperative, Gender, Eye color, Blood group, Hair color
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Pain, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Pain Sensitive Questionnaire (PSQ) Corah's Dental Anxiety Scale (CDAS) Pain Catastrophizing Scale (PCS) Gender Eye color Hair color Blood group
| Study group | Role | What they receive |
|---|---|---|
| Open-label cohort, with short follow-up | Other | 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain 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"
Measured: Information gathering on the morning of day 1
Postoperative pain 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"
Measured: Information gathering on the evening of day 1
Postoperative pain 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"
Measured: Information gathering on the morning of day 2
Postoperative pain 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"
Measured: Information gathering on the evening of day 2
Postoperative pain 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"
Measured: Information gathering on the morning of day 3
Postoperative pain 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"
Measured: Information gathering on the evening of day 3
Postoperative pain 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"
Measured: Information gathering on the morning of day 4
Postoperative pain 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"
Measured: Information gathering on the evening of day 4
Postoperative pain 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"
Measured: Information gathering on the morning of day 5
Postoperative pain 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"
Measured: Information gathering on the evening of day 5
Secondary outcomes (7)
Explanatory variable 1: Pain Sensitive Questionnaire
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.
Measured: 1 time only before surgery
Explanatory variable 2: Corah's Dental Anxiety Scale (CDAS)
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)
Measured: 1 time only before surgery
Explanatory variable 3: Pain Catastrophizing Scale (PCS)
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.
Measured: 1 time only before surgery
Explanatory variable 4: Gender
Gender will be determined between male or female subject
Measured: 1 time only before surgery
Explanatory variable 5: Eye color
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
Measured: 1 time only before surgery
Explanatory variable 6: Hair color
Hair color will be determined by color:
Black Brown Blond Red
Measured: 1 time only before surgery
Explanatory variable 7: Blood group
The blood group will be determined by the groups:
O HAS B AB as well as Rhesus + or -
Measured: 1 time only before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Jul 2022
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Devoize, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405088
- Sponsor's protocol ID
- RBHP 2021 DEVOIZE 2
- Other IDs
- 2021-A02885-36
- Acronym
- PHEDOPO
- Status last verified
- May 2026
- First submitted
- 5 Apr 2022
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saliba V, Duale C, Dallel R, Berberi A, Mulliez A, Devoize L. Predicting Pain After Tooth Extraction With Easy-to-Collect Preoperative Variables. Oral Dis. 2026 May 5. doi: 10.1111/odi.70360. Online ahead of print.
PubMed 42083837
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively
- ClinicalTrials.gov ID
- NCT05405088
- Acronym / sponsor ID
- PHEDOPO / RBHP 2021 DEVOIZE 2
- Conditions
- Pain, Postoperative, Anxiety, Dental
- Keywords
- Pain, Oral surgery, Postoperative, Gender, Eye color, Blood group, Hair color
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 6 Jun 2022 (actual)
- 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.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open-label cohort, with short follow-up | Other | Other: QuestionnairesThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient, male or female, eligible for dental extraction under local anesthesia,
- Fluent in speaking and reading French.
- Able to give informed consent to research.
- Affiliation to a Social Security scheme.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesPain Sensitive Questionnaire (PSQ) Corah's Dental Anxiety Scale (CDAS) Pain Catastrophizing Scale (PCS) Gender Eye color Hair color Blood group | Other | Open-label cohort, with short follow-up |
Primary outcome
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"
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"
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"
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"
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"
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"
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"
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"
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"
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"
7 secondary outcomes
Explanatory variable 1: Pain Sensitive Questionnaire
Time frame: 1 time only before surgery
Explanatory variable 2: Corah's Dental Anxiety Scale (CDAS)
Time frame: 1 time only before surgery
Explanatory variable 3: Pain Catastrophizing Scale (PCS)
Time frame: 1 time only before surgery
Explanatory variable 4: Gender
Time frame: 1 time only before surgery
Explanatory variable 5: Eye color
Time frame: 1 time only before surgery
Explanatory variable 6: Hair color
Time frame: 1 time only before surgery
Explanatory variable 7: Blood group
Time frame: 1 time only before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Results publication: PubMed 42083837Saliba V, Duale C, Dallel R, Berberi A, Mulliez A, Devoize L. Predicting Pain After Tooth Extraction With Easy-to-Collect Preoperative Variables. Oral Dis. 2026 May 5. doi: 10.1111/odi.70360. Online ahead of print.
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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.
Laurent Devoize principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Pain, Postoperative and Anxiety, Dental, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain Day 1 (time frame: Information gathering on the morning of day 1). The study lists 10 primary outcomes in all. 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 NCT05405088, which also lists 1 linked publication.
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 13 May 2026.