PulpitidesNCT03472456
Endodontic Medications for Irreversible Pulpitis: Articaine or Eugenol?
An observational study of Pulpitides and Endodontic Inflammation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The objective of the study is to determine which of the two commonly used endodontic medications (Eugenol VS Articaine) is most effective in controlling postoperative pain in irreversible pulpitis of the mature permanent tooth in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulpitides, Endodontic Inflammation, Toothaches
- What is being tested?
- Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne and Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2018to 24 Oct 2019
- Phase
- Observational
- 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
Study population: Patients from the University Hospital (Dental Service) of Strasbourg (HUS)
Who may be able to join
- Adult patient, major, affiliated to a social health insurance scheme
- Patient having agreed to participate in the study
- Urgent consultant patient for irreversible pulpitis
- Patient understanding French
Who cannot join
- Refusal of the patient to participate in the study
- Impossibility of performing the surgical procedure
- Impossibility to give the subject information enlightened (difficulty of understanding ...)
- Subject under the protection of justice, or under guardianship
- General contraindication to endodontic treatment in 2 sessions (high risk of infectious endocarditis, for example)
- Chronic intake of analgesic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Articaine or Eugenol: a Study on the Choice of Endodontic Medication in the Emergency Management of Irreversible Pulpitis of a Mature Permanent Tooth
The objective of the study is to determine which of the two commonly used endodontic medications (Eugenol VS Articaine) is most effective in controlling postoperative pain in irreversible pulpitis of the mature permanent tooth in adults. To do so, an assessment of the pain felt by patients will be carried out a few days apart. The supposed results are that the medications are equivalent in terms of effectiveness on the pain, but could then present different economic arguments
Read the detailed description
In irreversible pulpitis of the mature permanent tooth, the enrolled patients receive endodontic medications (Eugenol or Articaine) in order to determine which one is the more efficient to control the pain.
These patients would have received the same medication without this study. That's why this is an obsevationnal study.
- Conditions
- Pulpitides, Endodontic Inflammation, Toothaches, Operative Dentistry
- Being tested
- Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne, Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol
- Medical subject headings
- Pulpitis, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïneDrug
Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne
Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenolDrug
Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol
| Study group | Role | What they receive |
|---|---|---|
| Articaïne | Not described Receives: Drug: Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne | |
| Eugénol | Not described Receives: Drug: Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evolution (decrease or increase the intensity of the pain)
Evolution of pain (using a score of 0 to 10)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start22 Mar 2018
- Primary completion22 Mar 2018
- Study completion24 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitidesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien OFFNER, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472456
- Sponsor's protocol ID
- 6953
- Status last verified
- Sep 2020
- First submitted
- 12 Feb 2018
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Articaine or Eugenol: a Study on the Choice of Endodontic Medication in the Emergency Management of Irreversible Pulpitis of a Mature Permanent Tooth
- ClinicalTrials.gov ID
- NCT03472456
- Acronym / sponsor ID
- 6953
- Conditions
- Pulpitides, Endodontic Inflammation, Toothaches, Operative Dentistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 21 Mar 2018 (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.
The objective of the study is to determine which of the two commonly used endodontic medications (Eugenol VS Articaine) is most effective in controlling postoperative pain in irreversible pulpitis of the mature permanent tooth in adults. To do so, an assessment of the pain felt by patients will be carried out a few days apart. The supposed results are that the medications are equivalent in terms of effectiveness on the pain, but could then present different economic arguments
Detailed description
In irreversible pulpitis of the mature permanent tooth, the enrolled patients receive endodontic medications (Eugenol or Articaine) in order to determine which one is the more efficient to control the pain.
These patients would have received the same medication without this study. That's why this is an obsevationnal study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Articaïne | – | Drug: Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne |
| Eugénol | – | Drug: Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the University Hospital (Dental Service) of Strasbourg (HUS)
Key inclusion criteria (4 listed)
- Adult patient, major, affiliated to a social health insurance scheme
- Patient having agreed to participate in the study
- Urgent consultant patient for irreversible pulpitis
- Patient understanding French
Key exclusion criteria (6 listed)
- Refusal of the patient to participate in the study
- Impossibility of performing the surgical procedure
- Impossibility to give the subject information enlightened (difficulty of understanding ...)
- Subject under the protection of justice, or under guardianship
- General contraindication to endodontic treatment in 2 sessions (high risk of infectious endocarditis, for example)
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 |
|---|---|---|
| Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïneImplementation of a pulp medication in compliance with the dental emergency management protocol: articaïne | Drug | Articaïne |
| Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenolImplementation of a pulp medication in compliance with the dental emergency management protocol: eugenol | Drug | Eugénol |
Primary outcome
Pain evolution (decrease or increase the intensity of the pain)
Time frame: 7 days
Evolution of pain (using a score of 0 to 10)
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 17 Sep 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Pulpitides
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
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.
Damien OFFNER principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulpitides and Endodontic Inflammation, run by University Hospital, Strasbourg, France 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 4 inclusion and 6 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 17 Sep 2020. 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?
Pain evolution (decrease or increase the intensity of the pain) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2020.