Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)

Root Canal Obturation Clinical Trial

— EndoPOP  

Official title:

Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP Root Canal Sealer: a Prospective, Comparative Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885686
• Other study ID #: EndoPOP
• Secondary ID: 2021-A00065-36
• Status: Completed
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: June 11, 2022

Study information

• Verified date: July 2022
• Source: Septodont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 11, 2022
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Root Canal Obturation

Intervention

Device:
• Endomethasone N RCS
Root canal sealer
• Endomethasone SP RCS
Root canal sealer

Locations

Country	Name	City	State
France	Cabinet dentaire	Agon-Coutainville
France	Cabinet dentaire	Betton
France	Cabinet dentaire	Chartres-de-Bretagne
France	Cabinet Dentaire	Cherbourg
France	Cabinet dentaire	Cherbourg
France	Cabinet dentaire	Dinan
France	Cabinet dentaire	Équeurdreville-Hainneville
France	Cabinet dentaire	Lamballe
France	Centre de santé dentaire Chevaleret	Paris
France	Centre dentaire Flandre	Paris
France	Cabinet dentaire	Pluguffan
France	Cabinet dentaire	Quimper
France	Cabinet dentaire	Rennes
France	Cabinet dentaire	Saint-Aubin-de-Médoc
France	Cabinet dentaire	Tinténiac

Sponsors (2)

Lead Sponsor	Collaborator
Septodont	Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum post-operative pain using a visual analogue scale (VAS : 0-100)	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.	from the end of the root canal treatment (Day 0) to Day 7
Secondary	Spontaneous pain intensity	The spontaneous pain intensity measured using a Visual Analogue Scale (VAS: 0-100mm; 0 no pain - 100 maximum pain)	from the end of the root canal treatment (Day 0) to Day 7
Secondary	Occurrence of spontaneous pain flare-ups	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.	From Day 3 to Day7
Secondary	Masticatory pain intensity	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).	from the end of the root canal treatment (Day 0) to Day 7
Secondary	Maximum Masticatory pain intensity using a visual analogue scale (VAS : 0-100mm)	The maximum masticatory pain intensity measured Visual Analogue Scale (VAS: 0-100mm; 0 no pain- 100 maximum pain)	from the end of the root canal treatment (Day 0) to Day 7
Secondary	Use of oral pain treatment	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.	from the end of the root canal treatment (Day 0) to Day 7
Secondary	Quality of life with the OHIP-17 questionnaire (score 0-68)	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.	baseline and from 48 to 72 hours
Secondary	Adverse events	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	from the inclusion (Day 0) to Day 7