Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

Root Canal Obturation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04935736
• Other study ID #: CORT-SP
• Secondary ID: 2021-A00525-36
• Status: Completed
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: February 2022
• Source: ACTEON Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: January 15, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Postoperative
• Root Canal Obturation

Intervention

Device:
• root canal sealer : CORTISOMOL SP
The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.
• root canal sealer : SEALITE REGULAR
The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.

Locations

Country	Name	City	State
France	Cabinet dentaire	Lamballe
France	Cabinet dentaire	Liffré
France	Cabinet dentaire	Plédran
France	Cabinet dentaire	Pluguffan
France	Cabinet dentaire	Rennes
France	CHU Rennes - Centre de Soins Dentaires	Rennes
France	Cabinet dentaire	Saint-Brieuc
France	Cabinet dentaire	Saint-Coulomb

Sponsors (2)

Lead Sponsor	Collaborator
ACTEON Group	Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain assessed by a VAS	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.	From the end of the root canal treatment (Day 0) to Day 7
Secondary	Use of oral pain treatment	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.	From the end of the root canal treatment (Day 0) to Day 7
Secondary	Number of adverse events	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.	From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14)