Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.
Study Details
Study Description
Brief 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).
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CORTISOMOL SP 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. |
Device: root canal sealer : CORTISOMOL SP
The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.
|
| Active Comparator: SEALITE REGULAR The Zinc oxide/Eugenol-type sealer is used in combination with gutta percha points for the permanent obturation of root canals. |
Device: root canal sealer : SEALITE REGULAR
The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.
|
Outcome Measures
Primary Outcome Measures
- Post-operative pain assessed by a VAS [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.
Secondary Outcome Measures
- Use of oral pain treatment [From the end of the root canal treatment (Day 0) to Day 7]
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.
- Number of adverse events [From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, age > 18 years old
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Patient requiring a primary or a secondary root canal treatment on a single or multi-rooted tooth.
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Informed consent signed
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Patient with social protection.
Exclusion Criteria:
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Endodontic treatment on tooth with suspected root perforation, or immature tooth,
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Known allergy to corticosteroids, local anesthetics, or any component of the medical devices,
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Patient taking anti-pain or anti-inflammatory treatment regularly for another pathology,
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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,
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Participation in another intervnetional clinical trial or subject still within the exclusion period of a previous clinical trial,
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cabinet dentaire | Lamballe | France | 22400 | |
| 2 | Cabinet dentaire | Liffré | France | 35340 | |
| 3 | Cabinet dentaire | Pluguffan | France | 29700 | |
| 4 | Cabinet dentaire | Plédran | France | 22960 | |
| 5 | Cabinet dentaire | Rennes | France | 35000 | |
| 6 | CHU Rennes - Centre de Soins Dentaires | Rennes | France | 35000 | |
| 7 | Cabinet dentaire | Saint-Brieuc | France | 22000 | |
| 8 | Cabinet dentaire | Saint-Coulomb | France | 35350 |
Sponsors and Collaborators
- ACTEON Group
- Slb Pharma
Investigators
- Principal Investigator: Hugues Colombel, DDS, Cabinet dentaire (Rennes)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CORT-SP
- 2021-A00525-36