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Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

Primary Purpose

Root Canal Obturation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
root canal sealer : CORTISOMOL SP
root canal sealer : SEALITE REGULAR
Sponsored by
ACTEON Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Canal Obturation focused on measuring endodontic treatment, root canal sealer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Cabinet dentaire
  • Cabinet dentaire
  • Cabinet dentaire
  • Cabinet dentaire
  • Cabinet dentaire
  • CHU Rennes - Centre de Soins Dentaires
  • Cabinet dentaire
  • Cabinet dentaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CORTISOMOL SP

SEALITE REGULAR

Arm Description

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.

The Zinc oxide/Eugenol-type sealer is used in combination with gutta percha points for the permanent obturation of root canals.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 9, 2021
Last Updated
February 14, 2022
Sponsor
ACTEON Group
Collaborators
Slb Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04935736
Brief Title
Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
January 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACTEON Group
Collaborators
Slb Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Obturation
Keywords
endodontic treatment, root canal sealer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study subject (tooth) will be randomized in a 1:1 allocation ratio between the 2 treatment groups.
Masking
Participant
Masking Description
the participant will be blind from the treatment
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CORTISOMOL SP
Arm Type
Experimental
Arm Description
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.
Arm Title
SEALITE REGULAR
Arm Type
Active Comparator
Arm Description
The Zinc oxide/Eugenol-type sealer is used in combination with gutta percha points for the permanent obturation of root canals.
Intervention Type
Device
Intervention Name(s)
root canal sealer : CORTISOMOL SP
Intervention Description
The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.
Intervention Type
Device
Intervention Name(s)
root canal sealer : SEALITE REGULAR
Intervention Description
The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.
Primary Outcome Measure Information:
Title
Post-operative pain assessed by a VAS
Description
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.
Time Frame
From the end of the root canal treatment (Day 0) to Day 7
Secondary Outcome Measure Information:
Title
Use of oral pain treatment
Description
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.
Time Frame
From the end of the root canal treatment (Day 0) to Day 7
Title
Number of adverse events
Description
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.
Time Frame
From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugues Colombel, DDS
Organizational Affiliation
Cabinet dentaire (Rennes)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet dentaire
City
Lamballe
ZIP/Postal Code
22400
Country
France
Facility Name
Cabinet dentaire
City
Liffré
ZIP/Postal Code
35340
Country
France
Facility Name
Cabinet dentaire
City
Pluguffan
ZIP/Postal Code
29700
Country
France
Facility Name
Cabinet dentaire
City
Plédran
ZIP/Postal Code
22960
Country
France
Facility Name
Cabinet dentaire
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
CHU Rennes - Centre de Soins Dentaires
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Cabinet dentaire
City
Saint-Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Cabinet dentaire
City
Saint-Coulomb
ZIP/Postal Code
35350
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

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