Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Root Canal Obturation

Intervention / Treatment
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* Device: root canal sealer : CORTISOMOL SP
* Device: root canal sealer : SEALITE REGULAR


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study subject (tooth) will be randomized in a 1:1 allocation ratio between the 2 treatment groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CORTISOMOL SP<br>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<br>* The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.<br>|
| Active Comparator: SEALITE REGULAR<br>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<br>* The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From the end of the root canal treatment (Day 0) to Day 7 | 
| 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. | From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endodontic treatment, root canal sealer