Clinical trial NCT04935736: Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Obturation
Keywords: endodontic treatment
root canal sealer
Lead sponsor: ACTEON Group
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2021-06-23
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study subject (tooth) will be randomized in a 1:1 allocation ratio between the 2 treatment groups.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Post-operative pain assessed by a VAS
timeFrame: From the end of the root canal treatment (Day 0) to Day 7
Secondary outcomes:
measure: Use of oral pain treatment
timeFrame: From the end of the root canal treatment (Day 0) to Day 7
measure: Number of adverse events
timeFrame: From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14)
Other outcomes:
Locations:
city: Lamballe
country: France
facility: Cabinet dentaire
city: Liffré
country: France
facility: Cabinet dentaire
city: Pluguffan
country: France
facility: Cabinet dentaire
city: Plédran
country: France
facility: Cabinet dentaire
city: Rennes
country: France
facility: Cabinet dentaire
city: Rennes
country: France
facility: CHU Rennes - Centre de Soins Dentaires
city: Saint-Brieuc
country: France
facility: Cabinet dentaire
city: Saint-Coulomb
country: France
facility: Cabinet dentaire
Study officials:
affiliation: Cabinet dentaire (Rennes)
name: Hugues Colombel, DDS
role: PRINCIPAL_INVESTIGATOR
References: