Root Canal Obturation
Conditions
Keywords
Endodontics, root canal sealer, post-operative pain, zinc oxide eugenol, hydrocortisone, corticoid, root canal treatment
Brief summary
The study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). The aim of the study is to demonstrate the superiority of the hydrocortisone-containing root canal sealer Endomethasone N RCS, compared to the hydrocortisone-free root canal sealer Endomethasone SP RCS, with regard to reduction of the maximum post-operative spontaneous pain during the 7 days following the root canal treatment. Root canal treatment procedures will be in accordance with the allocation by randomisation of Endomethasone N RCS or Endomethasone SP RCS. The spontaneous and the Masticatory pain will be record at predefined times, a phone call will be done at 48h and a visit will be realized at day 7 (max Day 14).
Interventions
DEVICEEndomethasone N RCS
Root canal sealer
DEVICEEndomethasone SP RCS
Root canal sealer
Sponsors
Septodont
Slb Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The color of the two powders are not the same. The dentist will not be blinded to the treatment, but the patient will. The study is simple-blinded.
Intervention model description
Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups; the allocation will be stratified by pre-operative pain (3 classes) and center (12 classes).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult male or female (age ≥ 18 years); * Patient requiring root canal treatment or retreatment; * Patient who will need a single visit for the root canal therapy, for a mature molar or second premolar, with or without pre-operative pain * Patient who received information and gave written consent (signed informed consent form); * Subject affiliated to a health insurance system, or is a beneficiary (art. L.1121-11, Code of Public Health, France).
Exclusion criteria
* Pulpotomy or pulpectomy performed at a prior visit; * Tooth with apical calcification (sealer unable to reach the root apex); * Tooth with suspected root perforation; * Immature tooth (too wide root apex requiring an apexification); * Other dental treatment ongoing or scheduled within the study period; * At least one symptomatic tooth among those that are not included in this study * Known hypersensitivity to steroids, local anesthetics, or any component of study medical devices; * Subject using long term anti-inflammatory drugs; * Use of illicit substances during the 48h before the first visit (cannabis, cocaine…); * 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; * Subject who cannot be contacted in case of emergency (phone number); * Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial; * Vulnerable subjects (art. L.1121-5 and L.1122-1-2, Code of Public Health, France; art. 66 of the Regulation (EU) 2017/745 on medical devices)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum post-operative pain using a visual analogue scale (VAS : 0-100) | 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 (VAS: 0-100 mm; 0 no pain - 100 maximum pain) at different times after endodontic treatment (at the end of the root canal obturation, 3h, 6h 12h, 24h, Day 2, Day 3, Day 4 Day 5, Day 5, Day 7). The maximum pain felt will be compared between the 2 groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Masticatory pain intensity using a visual analogue scale (VAS : 0-100mm) | from the end of the root canal treatment (Day 0) to Day 7 | The maximum masticatory pain intensity measured Visual Analogue Scale (VAS: 0-100mm; 0 no pain- 100 maximum pain) |
| Use of oral pain treatment | 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 and the treatment categories will be compared between the 2 groups. |
| Quality of life with the OHIP-17 questionnaire (score 0-68) | baseline and from 48 to 72 hours | The answers and the total score from the OHIP 17-items questionnaire (measured at baseline and 48 h) will be compared between 2 groups. Score between 0 and 68, 0 means no dental issuel, 68 all the issues very often. |
| Adverse events | from the inclusion (Day 0) to Day 7 | Adverse events reported by patients on a diary from Day 0 to Day 7 and adverse events clinically observed by the dental surgeon at each follow-up visit will be used to assess the safety of root canal sealers and endodontic procedures |
| Spontaneous pain intensity | from the end of the root canal treatment (Day 0) to Day 7 | The spontaneous pain intensity measured using a Visual Analogue Scale (VAS: 0-100mm; 0 no pain - 100 maximum pain) |
| Masticatory pain intensity | from the end of the root canal treatment (Day 0) to Day 7 | The masticatory pain intensity measured using a Visual Analogue Scale (VAS: 0-100mm; 0 no pain -100 maximum pain) assessed twice a day from Day 0 to Day3 (lunch and dinner), and once a day from Day 4 to Day7 (dinner). |
| Occurrence of spontaneous pain flare-ups | From Day 3 to Day7 | The occurrence of spontaneous pain flare-ups is an increase of 20 mm in the Visual Analogue Scale (VAS: 0-100mm; 0 no pain-100 maximum pain) between 2 consecutive measurements after the firsts 3 days. |
Countries
France
Contacts
STUDY_DIRECTORYves BOUCHER, PU-PH
APHP
Outcome results
None listed