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OpenTrials
Completed

NCT Number: NCT04935736

Postoperative Pain After Root Canal Obturation With Sealer Containing Prednisolone.

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.

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Key information

Conditions

Root Canal Obturation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cabinet dentaire, Lamballe, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

root canal sealer : CORTISOMOL SP

Device

The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.

root canal sealer : SEALITE REGULAR

Device

The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

ACTEON Group

Industry

Collaborators

  • Slb Pharma

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2021
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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