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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
243
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.
Cabinet dentaire
Lamballe, France
Cabinet dentaire
Liffré, France
Cabinet dentaire
Plédran, France
Cabinet dentaire
Pluguffan, France
Cabinet dentaire
Rennes, France
CHU Rennes - Centre de Soins Dentaires
Rennes, France
Cabinet dentaire
Saint-Brieuc, France
Cabinet dentaire
Saint-Coulomb, France
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.
Time frame: From the end of the root canal treatment (Day 0) to Day 7
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.
Time frame: 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.
Time frame: From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14)
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