Root Canal ObturationNCT03874949
Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone
A study testing SEALITE Regular and SEALITE Ultra in people with Root Canal Obturation, run by ACTEON Group at 1 site in France.
Trial summary
This study aims to assess the efficacy of a zinc oxide eugenol sealer containing Enoxolone, a non-steroidal anti inflammatory drug (NSAID) on the pain relief after endodontic treatment. The study design is a multicenter, doubled blinded randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Root Canal Obturation
- What is being tested?
- SEALITE Regular and SEALITE Ultra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2019to 20 Aug 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female aged from 18 to 70 years,
- patient requiring root canal treatment on permanent mature teeth (single rooted teeth, premolar or molar),
- Informed consent signed,
- Patient with social protection.
Who cannot join
- root canal retreatment,
- root canal treatment on an immature tooth,
- calcified root canal assessed radiographically,
- Patient with one or more documented contraindication to endodontic treatment,
- Patient who takes regular analgesic or anti-inflammatory therapy for another pathology,
- Known allergy to NSAID or to one component of the sealer formula,
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- Participation to another clinical trial at the same time,
- known pregnancy or lactation,
- Patients with legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone: a Randomized Clinical Trial
This study aims to assess the efficacy of a zinc oxide eugenol sealer containing Enoxolone, a non-steroidal anti inflammatory drug (NSAID) on the pain relief after endodontic treatment.
The study design is a multicenter, doubled blinded randomized controlled trial. The comparator is the equivalent zinc oxide eugenol sealer without NSAID (allocation ratio is 1:1). The conventional endodontic treatment, using gutta percha and sealer, is done. Patients assess their pain for 7 days after permanent root obturation.
- Conditions
- Root Canal Obturation
- Being tested
- SEALITE Regular, SEALITE Ultra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEALITE RegularDevice
Patients are treated with SEALITE Regular sealer (zinc oxide eugenol sealer). The SEALITE Regular powder is mixed with SEALITE Liquid according to the manufacturer instructions and added to gutta percha in the root canal for permanent obturation. The apical obturation is assessed by a postoperative radiographic control.
SEALITE UltraDevice
Patients are treated with SEALITE Ultra sealer (zinc oxide eugenol sealer containing 1% Enoxolone).
The SEALITE Ultra powder is mixed with SEALITE Liquid according to the manufacturer instructions and added to gutta percha in the root canal for permanent obturation. The apical obturation is assessed by a postoperative radiographic control.
| Study group | Role | What they receive |
|---|---|---|
| SEALITE Regular | Active comparator | zinc oxide eugenol sealer Receives: Device: SEALITE Regular |
| SEALITE Ultra | Experimental | zinc oxide eugenol sealer containing 1% Enoxolone (NSAID) Receives: Device: SEALITE Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
To assess the efficacy of Enoxolone contained in the SEALITE Ultra formula compared to the SEALITE Regular formula, the pain is assessed by patients on a diary using a Visual Analogue Scale (VAS : 0-100 mm) 24 hours after the root canal obturation.
Measured: 24 hours
Secondary outcomes (3)
Pain response profil
Patients reporte their pain in a diary at different times after endodontic treatment using a VAS : T0 (at the end of the surgery), 6h post-op, 12h, 24h, Day 2, Day 3, Day 7, and at any other time if necessary. The maximum pain felt is compared between the 2 groups.
Measured: 0 hour, 6 hours, 12 hours, 24 hours, Day 2, Day 3, Day 7
Use of oral pain treatment
Patients reporte the consumption of analgesic treatment in a diary. The proportion of patients who took oral pain medication and the treatment categories are compared between the 2 groups.
Measured: 7 days
Adverse events
Adverse events reported by patients on a diary from Day 0 to Day 7 and clinically observed by the dental surgeon will assess the safety and tolerability of sealers and endodontic procedures.
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 posted14 Mar 2019
- Study start2 Apr 2019
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Subject will be randomized in a 1:1 allocation ratio between the two treatment groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACTEON Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Hugues Colombel, MD, Principal investigator, Private dental practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874949
- Sponsor's protocol ID
- SEAU
- Status last verified
- Sep 2019
- First submitted
- 11 Mar 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03874949
- Acronym / sponsor ID
- SEAU
- Conditions
- Root Canal Obturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- ACTEON GroupIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 14 Mar 2019 (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 study aims to assess the efficacy of a zinc oxide eugenol sealer containing Enoxolone, a non-steroidal anti inflammatory drug (NSAID) on the pain relief after endodontic treatment.
The study design is a multicenter, doubled blinded randomized controlled trial. The comparator is the equivalent zinc oxide eugenol sealer without NSAID (allocation ratio is 1:1). The conventional endodontic treatment, using gutta percha and sealer, is done. Patients assess their pain for 7 days after permanent root obturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subject will be randomized in a 1:1 allocation ratio between the two treatment groups.
| Arm | Type | Receives |
|---|---|---|
| SEALITE Regular | Active comparator | Device: SEALITE Regularzinc oxide eugenol sealer |
| SEALITE Ultra | Experimental | Device: SEALITE Ultrazinc oxide eugenol sealer containing 1% Enoxolone (NSAID) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female aged from 18 to 70 years,
- patient requiring root canal treatment on permanent mature teeth (single rooted teeth, premolar or molar),
- Informed consent signed,
- Patient with social protection.
Key exclusion criteria (9 listed)
- root canal retreatment,
- root canal treatment on an immature tooth,
- calcified root canal assessed radiographically,
- Patient with one or more documented contraindication to endodontic treatment,
- Patient who takes regular analgesic or anti-inflammatory therapy for another pathology,
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 |
|---|---|---|
| SEALITE RegularPatients are treated with SEALITE Regular sealer (zinc oxide eugenol sealer). The SEALITE Regular powder is mixed with SEALITE Liquid according to the manufacturer instructions and added to gutta percha in the root canal for permanent obturation. The apical obturation is assessed by a postoperative radiographic control. | Device | SEALITE Regular |
| SEALITE UltraPatients are treated with SEALITE Ultra sealer (zinc oxide eugenol sealer containing 1% Enoxolone). The SEALITE Ultra powder is mixed with SEALITE Liquid according to the manufacturer instructions and added to gutta percha in the root canal for permanent obturation. The apical obturation is assessed by a postoperative radiographic control. | Device | SEALITE Ultra |
Primary outcome
Postoperative pain
Time frame: 24 hours
To assess the efficacy of Enoxolone contained in the SEALITE Ultra formula compared to the SEALITE Regular formula, the pain is assessed by patients on a diary using a Visual Analogue Scale (VAS : 0-100 mm) 24 hours after the root canal obturation.
3 secondary outcomes
Pain response profil
Time frame: 0 hour, 6 hours, 12 hours, 24 hours, Day 2, Day 3, Day 7
Use of oral pain treatment
Time frame: 7 days
Adverse events
Time frame: 7 days
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 4 Sep 2019.
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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.
Hugues Colombel, MD principal investigator
Private dental practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEALITE Regular and SEALITE Ultra in people with Root Canal Obturation, run by ACTEON Group 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 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 4 Sep 2019. 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 (time frame: 24 hours). 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 4 Sep 2019.