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

Primary Purpose

Root Canal Obturation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endomethasone N RCS
Endomethasone SP RCS
Sponsored by
Septodont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Canal Obturation focused on measuring Endodontics, root canal sealer, post-operative pain, zinc oxide eugenol, hydrocortisone, corticoid, root canal treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cabinet dentaire
  • Cabinet dentaire
  • Cabinet dentaire
  • Cabinet Dentaire
  • Cabinet dentaire
  • Cabinet dentaire
  • Cabinet dentaire
  • Centre de santé dentaire Chevaleret
  • Centre dentaire Flandre
  • Cabinet dentaire
  • Cabinet dentaire
  • Cabinet dentaire
  • Cabinet dentaire
  • Cabinet dentaire
  • Cabinet dentaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endomethasone N RCS

Endomethasone SP RCS

Arm Description

Endomethasone N RCS is used in combination with gutta percha points for the permanent obturation of root canals.

Endomethasone SP RCS is used in combination with gutta percha points for the permanent obturation of root canals.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Spontaneous pain intensity
The spontaneous pain intensity measured using a Visual Analogue Scale (VAS: 0-100mm; 0 no pain - 100 maximum pain)
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.
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).
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)
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.
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.
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

Full Information

First Posted
April 29, 2021
Last Updated
July 19, 2022
Sponsor
Septodont
Collaborators
Slb Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04885686
Brief Title
Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
July 6, 2021 (Actual)
Study Completion Date
June 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Septodont
Collaborators
Slb Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Obturation
Keywords
Endodontics, root canal sealer, post-operative pain, zinc oxide eugenol, hydrocortisone, corticoid, root canal treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Participant
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.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endomethasone N RCS
Arm Type
Experimental
Arm Description
Endomethasone N RCS is used in combination with gutta percha points for the permanent obturation of root canals.
Arm Title
Endomethasone SP RCS
Arm Type
Active Comparator
Arm Description
Endomethasone SP RCS is used in combination with gutta percha points for the permanent obturation of root canals.
Intervention Type
Device
Intervention Name(s)
Endomethasone N RCS
Intervention Description
Root canal sealer
Intervention Type
Device
Intervention Name(s)
Endomethasone SP RCS
Intervention Description
Root canal sealer
Primary Outcome Measure Information:
Title
Maximum post-operative pain using a visual analogue scale (VAS : 0-100)
Description
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
Secondary Outcome Measure Information:
Title
Spontaneous pain intensity
Description
The spontaneous pain intensity measured using a 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
Title
Occurrence of spontaneous pain flare-ups
Description
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 Day 3 to Day7
Title
Masticatory pain intensity
Description
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
Title
Maximum Masticatory pain intensity using a visual analogue scale (VAS : 0-100mm)
Description
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
Title
Use of oral pain treatment
Description
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
from the end of the root canal treatment (Day 0) to Day 7
Title
Quality of life with the OHIP-17 questionnaire (score 0-68)
Description
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
baseline and from 48 to 72 hours
Title
Adverse events
Description
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
Time Frame
from the inclusion (Day 0) to Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves BOUCHER, PU-PH
Organizational Affiliation
APHP
Official's Role
Study Director
Facility Information:
Facility Name
Cabinet dentaire
City
Agon-Coutainville
ZIP/Postal Code
50230
Country
France
Facility Name
Cabinet dentaire
City
Betton
ZIP/Postal Code
35830
Country
France
Facility Name
Cabinet dentaire
City
Chartres-de-Bretagne
ZIP/Postal Code
35131
Country
France
Facility Name
Cabinet Dentaire
City
Cherbourg
ZIP/Postal Code
50100
Country
France
Facility Name
Cabinet dentaire
City
Cherbourg
ZIP/Postal Code
50110
Country
France
Facility Name
Cabinet dentaire
City
Dinan
ZIP/Postal Code
35800
Country
France
Facility Name
Cabinet dentaire
City
Lamballe
ZIP/Postal Code
22400
Country
France
Facility Name
Centre de santé dentaire Chevaleret
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Centre dentaire Flandre
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Cabinet dentaire
City
Pluguffan
ZIP/Postal Code
29700
Country
France
Facility Name
Cabinet dentaire
City
Quimper
ZIP/Postal Code
29000
Country
France
Facility Name
Cabinet dentaire
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Cabinet dentaire
City
Saint-Aubin-de-Médoc
ZIP/Postal Code
33160
Country
France
Facility Name
Cabinet dentaire
City
Tinténiac
ZIP/Postal Code
35190
Country
France
Facility Name
Cabinet dentaire
City
Équeurdreville-Hainneville
ZIP/Postal Code
50120
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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