Endodontic DiseaseENDOVECUNCT05285176
Patients' Experiences During Endodontic Treatments Performed by Hospital Externs at the CHRU of Brest
An observational study of Endodontic Disease, run by University Hospital, Brest at 1 site in France.
Trial summary
Root canal treatment (RCT) consists in eliminating infected and / or inflammatory tissues inside the root canal system of the tooth by a chemo-mechanical preparation and then filling the latter in a three-dimensional, bacteriostatic and durable way to allow healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endodontic Disease
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2022to 9 Mar 2024
- 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
- Adult, Older adult
Study population: Volunteer patients of Brest Dental University Hospital treated by endodontic (root canal) treatment
Who may be able to join
- Patients of legal age who volunteered to participate in the study, having formulated their non-opposition
- Patients having been treated in the dental department of Brest dental university hospital by a dental student for an endodontic (=root canal) treatment
Who cannot join
- patient who has formulated his opposition
- patients not requiring endodontic treatment
- minor patients
- patients treated by the consultants or residents
- patients taking opioids, powerful psychotropic drugs or having taken Atarax® before the treatment or interview
- patients who are cognitively impaired or have a disability that impairs comprehension (hearing, speech)
- patients under the influence of drugs or alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients' Experiences During Endodontic Treatments Performed by Hospital Externs at the CHRU of Brest : a Qualitative Study
Root canal treatment (RCT) consists in eliminating infected and / or inflammatory tissues inside the root canal system of the tooth by a chemo-mechanical preparation and then filling the latter in a three-dimensional, bacteriostatic and durable way to allow healing. This treatment is commonly carried out and can sometimes be long and tedious, as for example on molars with several roots.
According to numerous studies, patients consider endodontic treatments as one of the most stress-inducing dental procedures. Another study also reports satisfaction during root canal treatment in public health service. There is a paucity in literature about patients'experience of endodontic treatment when they are carried out by dental students.
The main objective of this study is to investigate patients' experience of root canal treatment in Brest dental university hospital through a qualitative methodology, with individual interviews, a verbatim transcription, followed by a qualitative analysis . This type of research can enable to keep a broad approach of patients' experience and to stay faithful to it.
Read the detailed description
Volunteer patients are recruited during their endodontic treatment in Brest Dental Hospital. At the end of the treatment, the patients are asked to take part in an individual interview. The interview is carried out by a single investigator with the help of a question route, until data saturation. The interviews are transcribed verbatim and anonymously by the main investigator. The interviews are read by qualitative Analysis by two investigators in order to determine codes, gathered in categories. Then, the results will be written and discussed in an article.
- Conditions
- Endodontic Disease
- Keywords
- patient, experience, stress, satisfaction, confidence
- Medical subject headings
- Dental Pulp Diseases, Personal Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' experience of root canal treatment in Brest dental University hospital
Individualized semi-directed interview, analyzed by content analysis
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start25 Jul 2022
- Primary completion9 Jun 2023
- Study completion9 Mar 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 Endodontic DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Chevalier, Dr, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285176
- Sponsor's protocol ID
- ENDOVECU (29BRC21.0322)
- Acronym
- ENDOVECU
- Status last verified
- Aug 2024
- First submitted
- 1 Mar 2022
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Melgaco-Costa JL, Martins RC, Ferreira EF, Sobrinho AP. Patients' Perceptions of Endodontic Treatment as Part of Public Health Services: A Qualitative Study. Int J Environ Res Public Health. 2016 Apr 27;13(5):450. doi: 10.3390/ijerph13050450.
PubMed 27128932
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Experiences During Endodontic Treatments Performed by Hospital Externs at the CHRU of Brest : a Qualitative Study
- ClinicalTrials.gov ID
- NCT05285176
- Acronym / sponsor ID
- ENDOVECU / ENDOVECU (29BRC21.0322)
- Conditions
- Endodontic Disease
- Keywords
- patient, experience, stress, satisfaction, confidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Mar 2024 (actual)
- First posted
- 17 Mar 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.
Root canal treatment (RCT) consists in eliminating infected and / or inflammatory tissues inside the root canal system of the tooth by a chemo-mechanical preparation and then filling the latter in a three-dimensional, bacteriostatic and durable way to allow healing. This treatment is commonly carried out and can sometimes be long and tedious, as for example on molars with several roots.
According to numerous studies, patients consider endodontic treatments as one of the most stress-inducing dental procedures. Another study also reports satisfaction during root canal treatment in public health service. There is a paucity in literature about patients'experience of endodontic treatment when they are carried out by dental students.
The main objective of this study is to investigate patients' experience of root canal treatment in Brest dental university hospital through a qualitative methodology, with individual interviews, a verbatim transcription, followed by a qualitative analysis . This type of research can enable to keep a broad approach of patients' experience and to stay faithful to it.
Detailed description
Volunteer patients are recruited during their endodontic treatment in Brest Dental Hospital. At the end of the treatment, the patients are asked to take part in an individual interview. The interview is carried out by a single investigator with the help of a question route, until data saturation. The interviews are transcribed verbatim and anonymously by the main investigator. The interviews are read by qualitative Analysis by two investigators in order to determine codes, gathered in categories. Then, the results will be written and discussed in an article.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Volunteer patients of Brest Dental University Hospital treated by endodontic (root canal) treatment
Key inclusion criteria (2 listed)
- Patients of legal age who volunteered to participate in the study, having formulated their non-opposition
- Patients having been treated in the dental department of Brest dental university hospital by a dental student for an endodontic (=root canal) treatment
Key exclusion criteria (7 listed)
- patient who has formulated his opposition
- patients not requiring endodontic treatment
- minor patients
- patients treated by the consultants or residents
- patients taking opioids, powerful psychotropic drugs or having taken Atarax® before the treatment or interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients' experience of root canal treatment in Brest dental University hospital
Time frame: day 1
Individualized semi-directed interview, analyzed by content analysis
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 12 Aug 2024.
- Background: PubMed 27128932Melgaco-Costa JL, Martins RC, Ferreira EF, Sobrinho AP. Patients' Perceptions of Endodontic Treatment as Part of Public Health Services: A Qualitative Study. Int J Environ Res Public Health. 2016 Apr 27;13(5):450. doi: 10.3390/ijerph13050450.
- Related InfoLink provided by the sponsor.
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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Pulpitis
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Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
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.
Valérie Chevalier, Dr principal investigator
CHRU de Brest
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 Endodontic Disease, run by University Hospital, Brest 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 2 inclusion and 7 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 12 Aug 2024. 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?
Patients' experience of root canal treatment in Brest dental University hospital (time frame: day 1). 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 NCT05285176, 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 12 Aug 2024.