A Phase 3 interventional study of Experimenta group (standard of care + Methoxyflurane). and control group (standard of care + placebo). in Dental Pain and Sensation Disorder, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by University Hospital, Brest · Phase 3, Interventional, and Treatment
With a chronic shortage of dentists in some regions, and an increase in life expectancy and living conditions, the number of patients admitted to oral health emergencies is on the rise. Pain is the main reason for consultation, and is particularly exacerbated in the orofacial sphere. Dental pain has several etiologies: infectious, inflammatory or traumatic accidents.Beyond the ethical aspects of acute pain management, pain relief is a real objective. Despite prioritization systems, patients can wait a long time in an unsettled environment, with tired and sometimes aggressive patients. Numerous recommendations exist to improve analgesia in emergency departments, but there are still difficulties in effectively and rapidly managing acute dental and orofacial pain. To meet this demand and facilitate the treatment process, an alternative solution using methoxyflurane (Penthrox®) could be considered. This product, mainly intended for emergency services, has been approved in Europe since 2016 for the "emergency relief of moderate to severe pain associated with trauma in conscious adult patients". Thus, it would be interesting to assess the value of methoxyflurane (Penthrox®) in the management of pain in oral emergencies as a wait-and-see solution.
142 studies on the registry are indexed under Toothache; 28 are open to participants now.
This study's enrollment of 190 is above the median of 84 across 123 interventional studies indexed under Toothache.
Browse Toothache studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Experimenta group (standard of care + Methoxyflurane).
Drug: control group (standard of care + placebo).
standard of care + Methoxyflurane
standard of care + placebo
Pain assessed by a numerical rating scale at baseline and at T=15min post-treatment
Pain at baseline and at T=15min post-treatment, measured using a numerical rating scale (NRS) graded from 0 to 10 (0 means no pain, 10 means maximum imaginable pain)
Time frame: 15 minutes post-treatment
Pain intensity <4/10 (yes/no) at T=15min after treatment
Time frame: 15 minutes post-treatment
Pain assessed by a numerical rating scale at T=7min (immediate efficacy)
Pain at T=7 min post-treatment, measured using a numerical rating scale (NRS) graded from 0 to 10 (0 means no pain, 10 means maximum imaginable pain)
Time frame: 7 minutes post-treatment
Pain assessed by a numerical rating scale at T=40 minutes after treatment and just prior to treatment by the practitioner (persistence of efficacy)
Pain at T=40 min post-treatment, measured using a numerical rating scale (NRS) graded from 0 to 10 (0 means no pain, 10 means maximum imaginable pain)
Time frame: 40 minutes post-treatment
Assessment of Anxiety
Anxiety, measured at inclusion and just before chairside treatment using a translated and adapted anxiety questionnaire (MDAS: modified dental anxiety scale) Total score is a sum of all five items, range 5 to 25: 5 means not anxious, 25 means extremely anxious
Time frame: Just before chairside treatment
Measuring the amount of local anesthetic used during treatment
Time frame: 1 day
Post-care satisfaction questionnaire
Answers to 4 questions on overall satisfaction of the care, ranging from very dissatisfied to very satisfied
Time frame: End of the study (up to 1 day)
Pain assessed by a numerical rating scale at T=15min according to analgesic associated with methoxyflurane
Pain at T=15 min post-treatment, measured using a numerical rating scale (NRS) graded from 0 to 10 (0 means no pain, 10 means maximum imaginable pain)
Time frame: 15 minutes post-treatment
Pain assessed by a numerical rating scale at T=15min according to type of emergency
Pain at T=15 min post-treatment, measured using a numerical rating scale (NRS) graded from 0 to 10 (0 means no pain, 10 means maximum imaginable pain)
Time frame: 15 minutes post-treatment
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
Time frame: Data will be available beginning five years and ending fifteen years following the final study report completion.
Access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Oct 2025, 11 months.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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