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Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

NCT04935736 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2022-02-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Slb Pharma

    collaborator OTHER

  • ACTEON Group

    lead INDUSTRY

Principal Investigators

  • Hugues Colombel, DDS · Cabinet dentaire (Rennes)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2022-01-15
Completion
2022-01-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04935736 on ClinicalTrials.gov