Endomethasone N RCS
DeviceRoot canal sealer
NCT Number: NCT04885686
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cabinet dentaire, Agon-Coutainville, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Root canal sealer
Root canal sealer
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 (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.
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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)
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 and the treatment categories will be compared between the 2 groups.
Time frame: 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.
Time frame: 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
Septodont
Industry
Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP Root Canal Sealer: a Prospective, Comparative Randomized Clinical Trial
Acronym: EndoPOP
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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