Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-01-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Root Canal Obturation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study subject (tooth) will be randomized in a 1:1 allocation ratio between the 2 treatment groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

the participant will be blind from the treatment

Study Groups

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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.

Group Type EXPERIMENTAL

root canal sealer : CORTISOMOL SP

Intervention Type DEVICE

The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.

SEALITE REGULAR

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

Group Type ACTIVE_COMPARATOR

root canal sealer : SEALITE REGULAR

Intervention Type DEVICE

The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.

Interventions

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root canal sealer : CORTISOMOL SP

The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.

Intervention Type DEVICE

root canal sealer : SEALITE REGULAR

The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No