Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

Not Applicable

Completed

• Conditions: Root Canal Obturation

• Registration Number: NCT04935736
• Lead Sponsor: ACTEON Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-23
• Study Start: 2021-06-30
• Primary Completion: 2022-01-15
• Study Completion: 2022-01-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

CHU Rennes - Centre de Soins Dentaires; 🇫🇷 Rennes, France

Cabinet dentaire; 🇫🇷 Saint-Coulomb, France