Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

February 14, 2022 updated by: ACTEON Group

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

243

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lamballe, France, 22400
        • Cabinet dentaire
      • Liffré, France, 35340
        • Cabinet dentaire
      • Pluguffan, France, 29700
        • Cabinet dentaire
      • Plédran, France, 22960
        • Cabinet dentaire
      • Rennes, France, 35000
        • Cabinet dentaire
      • Rennes, France, 35000
        • CHU Rennes - Centre de Soins Dentaires
      • Saint-Brieuc, France, 22000
        • Cabinet dentaire
      • Saint-Coulomb, France, 35350
        • Cabinet dentaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CORTISOMOL SP
Zinc oxide/Eugenol-type sealer containing 1% Prednisolone Acetate. The sealer is used in combination with gutta percha points for the permanent obturation of root canals.
Device: root canal sealer : CORTISOMOL SP
The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.
Active Comparator: SEALITE REGULAR
The Zinc oxide/Eugenol-type sealer is used in combination with gutta percha points for the permanent obturation of root canals.
Device: root canal sealer : SEALITE REGULAR
The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain assessed by a VAS
Time Frame: 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.
From the end of the root canal treatment (Day 0) to Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of oral pain treatment
Time Frame: 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.
From the end of the root canal treatment (Day 0) to Day 7
Number of adverse events
Time Frame: 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.
From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ACTEON Group

Collaborators

Slb Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

January 15, 2022

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORT-SP
  • 2021-A00525-36 (Other Identifier: French National Agency oh Health (ANSM))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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