Root Canal ObturationNCT04935736
Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.
A study testing root canal sealer : CORTISOMOL SP and root canal sealer : SEALITE REGULAR in people with Root Canal Obturation, run by ACTEON Group at 8 sites in France.
Trial summary
The study design is a multicentric randomized controlled clinical trial. 238 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (119 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?
- root canal sealer : CORTISOMOL SP and root canal sealer : SEALITE REGULAR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 8 sitesFrance
- Study dates
- 30 Jun 2021to 15 Jan 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
- Male or female, age > 18 years old
- Patient requiring a primary or a secondary root canal treatment on a single or multi-rooted tooth.
- Informed consent signed
- Patient with social protection.
Who cannot join
- Endodontic treatment on tooth with suspected root perforation, or immature tooth,
- Known allergy to corticosteroids, local anesthetics, or any component of the medical devices,
- Patient taking anti-pain or anti-inflammatory treatment regularly for another pathology,
- 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,
- Participation in another intervnetional clinical trial or subject still within the exclusion period of a previous clinical trial,
- Vulnerable subjects referred to in articles L.1121-5 to 8 and L.1122-1-2 of the Public Health Code and article 66 of Regulation (EU) 2017/745 on medical devices are excluded from the investigation (such as known pregnancy or lactation, patients with legal protection).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Cabinet dentaire
Lamballe, 22400
Cabinet dentaire
Liffré, 35340
Cabinet dentaire
Plédran, 22960
Cabinet dentaire
Pluguffan, 29700
Cabinet dentaire
Rennes, 35000
CHU Rennes - Centre de Soins Dentaires
Rennes, 35000
Cabinet dentaire
Saint-Brieuc, 22000
Cabinet dentaire
Saint-Coulomb, 35350
About this study
Official title: Postoperative Pain Evaluation After Definitive Root Canal Obturation With Zinc Oxide/Eugenol-type Sealer Containing or Not 1% Prednisolone Acetate - Steroid Anti-inflammatory Agent: a Comparative, Randomized Clinical Trial.
The study design is a multicentric randomized controlled clinical trial. 238 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (119 in each group).
The aim is to assess the effectiveness and utility of the ancillary drug substance, prednisolone acetate (1%) contained in CORTISOMOL SP (Zinc Oxide/Eugenol-type sealer) to help to decrease the possible postoperative painful reactions after root canal treatment. SEALITE REGULAR, which has a similar formulation except it is prednisolone acetate-free, is used as the comparator sealer.
Read more
Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a Zinc oxide/Eugenol-type sealer (CORTISOMOL SP or SEALITE REGULAR) and gutta-percha.
Patients assess their pain for 7 days after permanent root canal obturation.
- Conditions
- Root Canal Obturation
- Being tested
- root canal sealer : CORTISOMOL SP, root canal sealer : SEALITE REGULAR
- Keywords
- endodontic treatment, root canal sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal sealer : CORTISOMOL SPDevice
The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.
root canal sealer : SEALITE REGULARDevice
The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.
| Study group | Role | What they receive |
|---|---|---|
| CORTISOMOL SP | Experimental | Zinc oxide/Eugenol-type sealer containing 1% Prednisolone Acetate. The sealer is used in combination with gutta percha points for the permanent obturation of root canals. Receives: Device: root canal sealer : CORTISOMOL SP |
| SEALITE REGULAR | Active comparator | The Zinc oxide/Eugenol-type sealer is used in combination with gutta percha points for the permanent obturation of root canals. Receives: Device: root canal sealer : SEALITE REGULAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain assessed by a VAS
The pain is assessed by patients in a diary using a Visual Analogue Scale (range from 0 (= no pain) to 100 (= the worst pain)) at different times after endodontic treatment from the end of the root canal obturation to 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 (2)
Use of oral pain treatment
Patients reported the consumption of analgesic treatment in a diary. The proportion of patients who took oral pain medication will be compared between the 2 groups.
Measured: From the end of the root canal treatment (Day 0) to Day 7
Number of adverse events
Adverse events recorded from the endodontic treatment to the end of follow-up visit will be used to assess the safety of root canal sealers and endodontic procedures.
Measured: From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start30 Jun 2021
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
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
- Study subject (tooth) will be randomized in a 1:1 allocation ratio between the 2 treatment groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACTEON Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Hugues Colombel, DDS, Principal investigator, Cabinet dentaire (Rennes)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935736
- Sponsor's protocol ID
- CORT-SP
- Other IDs
- 2021-A00525-36
- Status last verified
- Feb 2022
- First submitted
- 9 Jun 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Evaluation After Definitive Root Canal Obturation With Zinc Oxide/Eugenol-type Sealer Containing or Not 1% Prednisolone Acetate - Steroid Anti-inflammatory Agent: a Comparative, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04935736
- Acronym / sponsor ID
- CORT-SP
- Conditions
- Root Canal Obturation
- Keywords
- endodontic treatment, root canal sealer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- ACTEON GroupIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 23 Jun 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 design is a multicentric randomized controlled clinical trial. 238 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (119 in each group).
The aim is to assess the effectiveness and utility of the ancillary drug substance, prednisolone acetate (1%) contained in CORTISOMOL SP (Zinc Oxide/Eugenol-type sealer) to help to decrease the possible postoperative painful reactions after root canal treatment. SEALITE REGULAR, which has a similar formulation except it is prednisolone acetate-free, is used as the comparator sealer.
Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a Zinc oxide/Eugenol-type sealer (CORTISOMOL SP or SEALITE REGULAR) and gutta-percha.
Patients assess their pain for 7 days after permanent root canal obturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study subject (tooth) will be randomized in a 1:1 allocation ratio between the 2 treatment groups.
| Arm | Type | Receives |
|---|---|---|
| CORTISOMOL SP | Experimental | Device: root canal sealer : CORTISOMOL SPZinc oxide/Eugenol-type sealer containing 1% Prednisolone Acetate. The sealer is used in combination with gutta percha points for the permanent obturation of root canals. |
| SEALITE REGULAR | Active comparator | Device: root canal sealer : SEALITE REGULARThe Zinc oxide/Eugenol-type sealer 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 (4 listed)
- Male or female, age > 18 years old
- Patient requiring a primary or a secondary root canal treatment on a single or multi-rooted tooth.
- Informed consent signed
- Patient with social protection.
Key exclusion criteria (6 listed)
- Endodontic treatment on tooth with suspected root perforation, or immature tooth,
- Known allergy to corticosteroids, local anesthetics, or any component of the medical devices,
- Patient taking anti-pain or anti-inflammatory treatment regularly for another pathology,
- 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,
- Participation in another intervnetional clinical trial or subject still within the exclusion period of a previous clinical trial,
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 |
|---|---|---|
| root canal sealer : CORTISOMOL SPThe participant will be treated with CORTISOMOL SP sealer in combination with gutta percha. | Device | CORTISOMOL SP |
| root canal sealer : SEALITE REGULARThe participant will be treated with SEALITE REGULAR sealer in combination with gutta percha. | Device | SEALITE REGULAR |
Primary outcome
Post-operative pain assessed by a VAS
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 (range from 0 (= no pain) to 100 (= the worst pain)) at different times after endodontic treatment from the end of the root canal obturation to Day 7. The maximum pain felt will be compared between the 2 groups.
2 secondary outcomes
Use of oral pain treatment
Time frame: From the end of the root canal treatment (Day 0) to Day 7
Number of adverse events
Time frame: From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14)
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 15 Feb 2022.
- 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.
Hugues Colombel, DDS principal investigator
Cabinet dentaire (Rennes)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal sealer : CORTISOMOL SP and root canal sealer : SEALITE REGULAR in people with Root Canal Obturation, run by ACTEON Group at 8 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 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 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Post-operative pain assessed by a VAS (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?
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 15 Feb 2022.