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.
2 other identifiers
interventional
243
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2022
CompletedFebruary 15, 2022
February 1, 2022
7 months
June 9, 2021
February 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Use of oral pain treatment
From the end of the root canal treatment (Day 0) to Day 7
Number of adverse events
From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14)
Study Arms (2)
CORTISOMOL SP
EXPERIMENTALZinc 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.
SEALITE REGULAR
ACTIVE COMPARATORThe Zinc oxide/Eugenol-type sealer is used in combination with gutta percha points for the permanent obturation of root canals.
Interventions
The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.
The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ACTEON Grouplead
- Slb Pharmacollaborator
Study Sites (8)
Cabinet dentaire
Lamballe, 22400, France
Cabinet dentaire
Liffré, 35340, France
Cabinet dentaire
Plédran, 22960, France
Cabinet dentaire
Pluguffan, 29700, France
Cabinet dentaire
Rennes, 35000, France
CHU Rennes - Centre de Soins Dentaires
Rennes, 35000, France
Cabinet dentaire
Saint-Brieuc, 22000, France
Cabinet dentaire
Saint-Coulomb, 35350, France
Study Officials
- PRINCIPAL INVESTIGATOR
Hugues Colombel, DDS
Cabinet dentaire (Rennes)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- the participant will be blind from the treatment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2021
First Posted
June 23, 2021
Study Start
June 30, 2021
Primary Completion
January 15, 2022
Study Completion
January 15, 2022
Last Updated
February 15, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share