NCT04935736

Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: ACTEON Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Root Canal Obturation

Interventions

Type	Name	Description
DEVICE	root canal sealer : CORTISOMOL SP	The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.
DEVICE	root canal sealer : SEALITE REGULAR	The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-01-15
• Completion: 2022-01-15
• First posted: 2021-06-23
• Last updated: 2022-02-15

Locations

8 sites across 1 country: France