Root Canal ObturationEndoPOPNCT04885686
Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)
A study testing Endomethasone N RCS and Endomethasone SP RCS in people with Root Canal Obturation, run by Septodont at 15 sites in France.
Trial summary
The study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Root Canal Obturation
- What is being tested?
- Endomethasone N RCS and Endomethasone SP RCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 15 sitesFrance
- Study dates
- 22 Jun 2021to 11 Jun 2022
- 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 male or female (age ≥ 18 years);
- Patient requiring root canal treatment or retreatment;
- Patient who will need a single visit for the root canal therapy, for a mature molar or second premolar, with or without pre-operative pain
- Patient who received information and gave written consent (signed informed consent form);
- Subject affiliated to a health insurance system, or is a beneficiary (art. L.1121-11, Code of Public Health, France).
Who cannot join
- Pulpotomy or pulpectomy performed at a prior visit;
- Tooth with apical calcification (sealer unable to reach the root apex);
- Tooth with suspected root perforation;
- Immature tooth (too wide root apex requiring an apexification);
- Other dental treatment ongoing or scheduled within the study period;
- At least one symptomatic tooth among those that are not included in this study
Show all 13Show fewer
- Known hypersensitivity to steroids, local anesthetics, or any component of study medical devices;
- Subject using long term anti-inflammatory drugs;
- Use of illicit substances during the 48h before the first visit (cannabis, cocaine…);
- Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator;
- Subject who cannot be contacted in case of emergency (phone number);
- Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial;
- Vulnerable subjects (art. L.1121-5 and L.1122-1-2, Code of Public Health, France; art. 66 of the Regulation (EU) 2017/745 on medical devices)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Cabinet dentaire
Agon-Coutainville, 50230
Cabinet dentaire
Betton, 35830
Cabinet dentaire
Chartres-de-Bretagne, 35131
Cabinet Dentaire
Cherbourg, 50100
Cabinet dentaire
Cherbourg, 50110
Cabinet dentaire
Dinan, 35800
Cabinet dentaire
Équeurdreville-Hainneville, 50120
Cabinet dentaire
Lamballe, 22400
Centre de santé dentaire Chevaleret
Paris, 75013
Centre dentaire Flandre
Paris, 75019
Cabinet dentaire
Pluguffan, 29700
Cabinet dentaire
Quimper, 29000
Cabinet dentaire
Rennes, 35000
Cabinet dentaire
Saint-Aubin-de-Médoc, 33160
Cabinet dentaire
Tinténiac, 35190
About this study
Official title: Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP Root Canal Sealer: a Prospective, Comparative Randomized Clinical Trial
The study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). The aim of the study is to demonstrate the superiority of the hydrocortisone-containing root canal sealer Endomethasone N RCS, compared to the hydrocortisone-free root canal sealer Endomethasone SP RCS, with regard to reduction of the maximum post-operative spontaneous pain during the 7 days following the root canal treatment.
Root canal treatment procedures will be in accordance with the allocation by randomisation of Endomethasone N RCS or Endomethasone SP RCS. The spontaneous and the Masticatory pain will be record at predefined times, a phone call will be done at 48h and a visit will be realized at day 7 (max Day 14).
- Conditions
- Root Canal Obturation
- Being tested
- Endomethasone N RCS, Endomethasone SP RCS
- Keywords
- Endodontics, root canal sealer, post-operative pain, zinc oxide eugenol, hydrocortisone, corticoid, root canal treatment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endomethasone N RCSDevice
Root canal sealer
Endomethasone SP RCSDevice
Root canal sealer
| Study group | Role | What they receive |
|---|---|---|
| Endomethasone N RCS | Experimental | Endomethasone N RCS is used in combination with gutta percha points for the permanent obturation of root canals. Receives: Device: Endomethasone N RCS |
| Endomethasone SP RCS | Active comparator | Endomethasone SP RCS is used in combination with gutta percha points for the permanent obturation of root canals. Receives: Device: Endomethasone SP RCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum post-operative pain using a visual analogue scale (VAS : 0-100)
The pain is assessed by patients in a diary using a Visual Analogue Scale (VAS: 0-100 mm; 0 no pain - 100 maximum pain) at different times after endodontic treatment (at the end of the root canal obturation, 3h, 6h 12h, 24h, Day 2, Day 3, Day 4 Day 5, Day 5, Day 7). The maximum pain felt will be compared between the 2 groups.
Measured: from the end of the root canal treatment (Day 0) to Day 7
Secondary outcomes (7)
Spontaneous pain intensity
The spontaneous pain intensity measured using a Visual Analogue Scale (VAS: 0-100mm; 0 no pain - 100 maximum pain)
Measured: from the end of the root canal treatment (Day 0) to Day 7
Occurrence of spontaneous pain flare-ups
The occurrence of spontaneous pain flare-ups is an increase of 20 mm in the Visual Analogue Scale (VAS: 0-100mm; 0 no pain-100 maximum pain) between 2 consecutive measurements after the firsts 3 days.
Measured: From Day 3 to Day7
Masticatory pain intensity
The masticatory pain intensity measured using a Visual Analogue Scale (VAS: 0-100mm; 0 no pain -100 maximum pain) assessed twice a day from Day 0 to Day3 (lunch and dinner), and once a day from Day 4 to Day7 (dinner).
Measured: from the end of the root canal treatment (Day 0) to Day 7
Maximum Masticatory pain intensity using a visual analogue scale (VAS : 0-100mm)
The maximum masticatory pain intensity measured Visual Analogue Scale (VAS: 0-100mm; 0 no pain- 100 maximum pain)
Measured: from the end of the root canal treatment (Day 0) to Day 7
Use of oral pain treatment
Patients reported the consumption of analgesic treatment in a diary. The proportion of patients who took oral pain medication and the treatment categories will be compared between the 2 groups.
Measured: from the end of the root canal treatment (Day 0) to Day 7
Quality of life with the OHIP-17 questionnaire (score 0-68)
The answers and the total score from the OHIP 17-items questionnaire (measured at baseline and 48 h) will be compared between 2 groups. Score between 0 and 68, 0 means no dental issuel, 68 all the issues very often.
Measured: baseline and from 48 to 72 hours
Adverse events
Adverse events reported by patients on a diary from Day 0 to Day 7 and adverse events clinically observed by the dental surgeon at each follow-up visit will be used to assess the safety of root canal sealers and endodontic procedures
Measured: from the inclusion (Day 0) to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start22 Jun 2021
- Primary completion6 Jul 2021
- Study completion11 Jun 2022
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 Root Canal ObturationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups; the allocation will be stratified by pre-operative pain (3 classes) and center (12 classes).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Septodont
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Yves BOUCHER, PU-PH, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885686
- Sponsor's protocol ID
- EndoPOP
- Other IDs
- 2021-A00065-36
- Acronym
- EndoPOP
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boucher Y, Abrgall H, Bar V, Basl-Th Bault FO, Cano S, Colombel H, Le Guicher G, Cameli C. Spontaneous and Masticatory Post-endodontic Pain After Using Endomethasone N vs SP Root Canal Sealers: A Randomised Controlled Clinical Trial. Eur Endod J. 2024 Aug 22;9(3):218-230. doi: 10.14744/eej.2024.96977.
PubMed 38644670
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP Root Canal Sealer: a Prospective, Comparative Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04885686
- Acronym / sponsor ID
- EndoPOP / EndoPOP
- Conditions
- Root Canal Obturation
- Keywords
- Endodontics, root canal sealer, post-operative pain, zinc oxide eugenol, hydrocortisone, corticoid, root canal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- SeptodontIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 11 Jun 2022 (actual)
- First posted
- 13 May 2021 (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 study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). The aim of the study is to demonstrate the superiority of the hydrocortisone-containing root canal sealer Endomethasone N RCS, compared to the hydrocortisone-free root canal sealer Endomethasone SP RCS, with regard to reduction of the maximum post-operative spontaneous pain during the 7 days following the root canal treatment.
Root canal treatment procedures will be in accordance with the allocation by randomisation of Endomethasone N RCS or Endomethasone SP RCS. The spontaneous and the Masticatory pain will be record at predefined times, a phone call will be done at 48h and a visit will be realized at day 7 (max Day 14).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups; the allocation will be stratified by pre-operative pain (3 classes) and center (12 classes).
| Arm | Type | Receives |
|---|---|---|
| Endomethasone N RCS | Experimental | Device: Endomethasone N RCSEndomethasone N RCS is used in combination with gutta percha points for the permanent obturation of root canals. |
| Endomethasone SP RCS | Active comparator | Device: Endomethasone SP RCSEndomethasone SP RCS is used in combination with gutta percha points for the permanent obturation of root canals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male or female (age ≥ 18 years);
- Patient requiring root canal treatment or retreatment;
- Patient who will need a single visit for the root canal therapy, for a mature molar or second premolar, with or without pre-operative pain
- Patient who received information and gave written consent (signed informed consent form);
- Subject affiliated to a health insurance system, or is a beneficiary (art. L.1121-11, Code of Public Health, France).
Key exclusion criteria (13 listed)
- Pulpotomy or pulpectomy performed at a prior visit;
- Tooth with apical calcification (sealer unable to reach the root apex);
- Tooth with suspected root perforation;
- Immature tooth (too wide root apex requiring an apexification);
- Other dental treatment ongoing or scheduled within the study period;
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 |
|---|---|---|
| Endomethasone N RCSRoot canal sealer | Device | Endomethasone N RCS |
| Endomethasone SP RCSRoot canal sealer | Device | Endomethasone SP RCS |
Primary outcome
Maximum post-operative pain using a visual analogue scale (VAS : 0-100)
Time frame: from the end of the root canal treatment (Day 0) to Day 7
The pain is assessed by patients in a diary using a Visual Analogue Scale (VAS: 0-100 mm; 0 no pain - 100 maximum pain) at different times after endodontic treatment (at the end of the root canal obturation, 3h, 6h 12h, 24h, Day 2, Day 3, Day 4 Day 5, Day 5, Day 7). The maximum pain felt will be compared between the 2 groups.
7 secondary outcomes
Spontaneous pain intensity
Time frame: from the end of the root canal treatment (Day 0) to Day 7
Occurrence of spontaneous pain flare-ups
Time frame: From Day 3 to Day7
Masticatory pain intensity
Time frame: from the end of the root canal treatment (Day 0) to Day 7
Maximum Masticatory pain intensity using a visual analogue scale (VAS : 0-100mm)
Time frame: from the end of the root canal treatment (Day 0) to Day 7
Use of oral pain treatment
Time frame: from the end of the root canal treatment (Day 0) to Day 7
Quality of life with the OHIP-17 questionnaire (score 0-68)
Time frame: baseline and from 48 to 72 hours
Adverse events
Time frame: from the inclusion (Day 0) to Day 7
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 6 May 2026.
- Results publication: PubMed 38644670Boucher Y, Abrgall H, Bar V, Basl-Th Bault FO, Cano S, Colombel H, Le Guicher G, Cameli C. Spontaneous and Masticatory Post-endodontic Pain After Using Endomethasone N vs SP Root Canal Sealers: A Randomised Controlled Clinical Trial. Eur Endod J. 2024 Aug 22;9(3):218-230. doi: 10.14744/eej.2024.96977.
- Individual participant dataSharing planned: No
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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.
Yves BOUCHER, PU-PH study director
APHP
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endomethasone N RCS and Endomethasone SP RCS in people with Root Canal Obturation, run by Septodont at 15 sites 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 5 inclusion and 13 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 6 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 15 sites 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?
Maximum post-operative pain using a visual analogue scale (VAS : 0-100) (time frame: from the end of the root canal treatment (Day 0) to Day 7). 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 NCT04885686, 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 6 May 2026.