Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

Acteon

Status: Completed

Conditions: Root Canal Obturation

Treatments: Device: root canal sealer : SEALITE REGULAR; Device: root canal sealer : CORTISOMOL SP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04935736

2021-A00525-36 (Other Identifier)

CORT-SP

Details and patient eligibility

About

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.

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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243 participants in 2 patient groups

CORTISOMOL SP

Experimental group

Description:

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.

Treatment:

Device: root canal sealer : CORTISOMOL SP

SEALITE REGULAR

Active Comparator group

Description:

The Zinc oxide/Eugenol-type sealer is used in combination with gutta percha points for the permanent obturation of root canals.

Treatment:

Device: root canal sealer : SEALITE REGULAR