Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312085
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-04
Brief Title:
A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material
Sponsor:
Lumendo AG
Organization:
Lumendo AG
Study Overview
Official Title:
A Prospective Single-arm Non-randomized Controlled Trial to Test the Effectiveness Safety and Performance of a Novel Dental Obturation Material
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is prospective single-arm non-randomized controlled trial to test the effectiveness safety and performance of a novel dental obturation material The main question sit answers is
1 To test the effectiveness of the Endofill device for root canal obturation up to 12-month follow-up period
2 To test the performance of the Endofill device evaluated with periapical radiographs immediately on completion of procedure
The participants requiring root canal treatment will be treated with obturated using Endofill material and post-treatment follow-up vistis will be conducted for 1 year This is a single-arm study with no comparison groups
1 To test the effectiveness of the Endofill device for root canal obturation up to 12-month follow-up period
2 To test the performance of the Endofill device evaluated with periapical radiographs immediately on completion of procedure
The participants requiring root canal treatment will be treated with obturated using Endofill material and post-treatment follow-up vistis will be conducted for 1 year This is a single-arm study with no comparison groups
Detailed Description:
Study Title
A prospective single-arm non-randomized controlled trial to test the effectiveness safety and performance of a novel dental obturation material
Protocol Version and Date Version 10 25 May 2023
Device Risk Category Risk category Class IIa Rule 8 - medium risk device according to EU MDR
Background and Rationale
Endofill EF is a low-viscosity injectable hydrophilic light- curable endodontic sealer It is an easy-to-use single- material root canal obturation solution that circumvents the disadvantages of existing products thus improving ease of handling and treatment time while maintaining the clinical outcome of root canal treatments at the level of state-of-the- art treatment methods
Endofill is used after a conventional access cavity preparation glide path preparation determination of the working length cleaningshaping of a root canal with a suitable device and irrigatingdisinfecting the canal with an irrigant solution
Endofill has undergone pre-clinical testing and is a safe product The benefits and risks of this investigational device shall be elaborated in the protocol
Primary objectives
To test the effectiveness of the Endofill device for root canal obturation up to 12-month follow-up period
To test the performance of the Endofill device evaluated with periapical radiographs immediately on completion of procedure
Secondary objectives
To test the safety and effectiveness of the Endofill device by evaluating the incidence of re-treatment cases up to a 12-month follow-up period
Primary endpoints Primary effectiveness endpoint To measure overall healing through rate of reduction in apical periodontitis from baseline up to 12 months post-procedure by measuring periapical radiolucency size
Success is measured by the PAI periapical index scores which will be recorded at 3m 6m and 12 months Success is defined as either a fully healed lesion ie with no periapical radiolucency visible on the radiograph at 12 month follow up or a healing lesion ie the periapical radiolucency has decreased in size at 12 month follow up compared to pre-procedure radiographic lesion size with no clinical symptoms such as pain or swelling
Performance endpoint
To measure the successful and complete obturation of root canal measured by examining the periapical radiograph taken immediately after obturation
Secondary endpoints
Safety endpoint To measure freedom from postoperative pain from completion of procedure up to 1 months of follow-up FU period 24 hours 48 hours 72 hours 7 days and 1 month Pain is measured by VAS assessment
Secondary effectiveness endpoint
Successful healing of periapical lesion up to 12 months post-procedure Long-term effectiveness success shall be defined as a continued reduction or complete absence of periapical lesion radiolucency at 12m follow up since procedure with no clinical symptoms ie no discomfort in treated tooth and no percussive pain during examination
Device failure shall be defined as root canal re-treatment or extraction requirement due to the treatment itself as the cause of failure up to 12m post procedure along with persistence of clinical symptoms
The study involves a safety check at 3 months time point post-procedure This check will be performed on the first 10 subjects to assess the safety effectiveness and performance of the evaluated device
A total of 63 subjects aged 18 years and above shall be included in this study Study Procedure
Subjects will be selected based on inclusion and exclusion criteria and subjects will be assigned a subject ID code for the study
Each subject shall receive the endodontic treatment as laid out in this protocol
Subject dropout is addressed in the statistical analysis plan
The follow-up period up to 12 months shall permit the demonstration of clinical effectiveness performance and safety over a period of time sufficient to represent a realistic test of the investigational device and allow any risks associated with adverse device effects to be identified and assessed
The planned enrollment period is 6-9 months The total expected duration of the clinical investigation is 2 - 25 years
Statistical Considerations
Full details of the analyses will be discussed in a separate statistical analysis plan SAP Briefly the following endpoints will be analyzed
Primary endpoints are
A reduction in PAI at 12 months compared to baseline The rate seen will be compared to a target rate of 085 using a non-inferiority test at a margin of 02
Successful obturation of the root canal at procedures completion The rate will be reported with its 95 Clopper-Pearson CI
The secondary endpoints are
Experiencing different levels of postoperative pain none mild moderate and severe at 24 hours 48 hours 72 hours 7 days 1 month after the procedure The rates will be reported with their 95 Clopper-Pearson confidence intervals
Root canal re-treatment in tooth treated with Endofill at 12 months post-procedure The rate will be reported with its 95 Clopper-Pearson confidence interval
Duration of the obturation procedure Summary statistics mean median max min IQR and range will be reported
Questionnaire about the quality and usability of the device
Summary statistics of results will be reported
Sample Size In order to be able to establish non-inferiority within a margin of 02 of the target rates of 085 a two-sided 95 confidence interval for the healing rate must lie above 085 - 02 065 Assuming a pessimistic scenario where the true underlying healing rate of the Endofill device is 002 lower than the target rate of 085 ie 083 data from 56 participants are needed This yields a power of 80 for the study Assuming a 10 drop out rate at 12 months the required sample size is 63
A prospective single-arm non-randomized controlled trial to test the effectiveness safety and performance of a novel dental obturation material
Protocol Version and Date Version 10 25 May 2023
Device Risk Category Risk category Class IIa Rule 8 - medium risk device according to EU MDR
Background and Rationale
Endofill EF is a low-viscosity injectable hydrophilic light- curable endodontic sealer It is an easy-to-use single- material root canal obturation solution that circumvents the disadvantages of existing products thus improving ease of handling and treatment time while maintaining the clinical outcome of root canal treatments at the level of state-of-the- art treatment methods
Endofill is used after a conventional access cavity preparation glide path preparation determination of the working length cleaningshaping of a root canal with a suitable device and irrigatingdisinfecting the canal with an irrigant solution
Endofill has undergone pre-clinical testing and is a safe product The benefits and risks of this investigational device shall be elaborated in the protocol
Primary objectives
To test the effectiveness of the Endofill device for root canal obturation up to 12-month follow-up period
To test the performance of the Endofill device evaluated with periapical radiographs immediately on completion of procedure
Secondary objectives
To test the safety and effectiveness of the Endofill device by evaluating the incidence of re-treatment cases up to a 12-month follow-up period
Primary endpoints Primary effectiveness endpoint To measure overall healing through rate of reduction in apical periodontitis from baseline up to 12 months post-procedure by measuring periapical radiolucency size
Success is measured by the PAI periapical index scores which will be recorded at 3m 6m and 12 months Success is defined as either a fully healed lesion ie with no periapical radiolucency visible on the radiograph at 12 month follow up or a healing lesion ie the periapical radiolucency has decreased in size at 12 month follow up compared to pre-procedure radiographic lesion size with no clinical symptoms such as pain or swelling
Performance endpoint
To measure the successful and complete obturation of root canal measured by examining the periapical radiograph taken immediately after obturation
Secondary endpoints
Safety endpoint To measure freedom from postoperative pain from completion of procedure up to 1 months of follow-up FU period 24 hours 48 hours 72 hours 7 days and 1 month Pain is measured by VAS assessment
Secondary effectiveness endpoint
Successful healing of periapical lesion up to 12 months post-procedure Long-term effectiveness success shall be defined as a continued reduction or complete absence of periapical lesion radiolucency at 12m follow up since procedure with no clinical symptoms ie no discomfort in treated tooth and no percussive pain during examination
Device failure shall be defined as root canal re-treatment or extraction requirement due to the treatment itself as the cause of failure up to 12m post procedure along with persistence of clinical symptoms
The study involves a safety check at 3 months time point post-procedure This check will be performed on the first 10 subjects to assess the safety effectiveness and performance of the evaluated device
A total of 63 subjects aged 18 years and above shall be included in this study Study Procedure
Subjects will be selected based on inclusion and exclusion criteria and subjects will be assigned a subject ID code for the study
Each subject shall receive the endodontic treatment as laid out in this protocol
Subject dropout is addressed in the statistical analysis plan
The follow-up period up to 12 months shall permit the demonstration of clinical effectiveness performance and safety over a period of time sufficient to represent a realistic test of the investigational device and allow any risks associated with adverse device effects to be identified and assessed
The planned enrollment period is 6-9 months The total expected duration of the clinical investigation is 2 - 25 years
Statistical Considerations
Full details of the analyses will be discussed in a separate statistical analysis plan SAP Briefly the following endpoints will be analyzed
Primary endpoints are
A reduction in PAI at 12 months compared to baseline The rate seen will be compared to a target rate of 085 using a non-inferiority test at a margin of 02
Successful obturation of the root canal at procedures completion The rate will be reported with its 95 Clopper-Pearson CI
The secondary endpoints are
Experiencing different levels of postoperative pain none mild moderate and severe at 24 hours 48 hours 72 hours 7 days 1 month after the procedure The rates will be reported with their 95 Clopper-Pearson confidence intervals
Root canal re-treatment in tooth treated with Endofill at 12 months post-procedure The rate will be reported with its 95 Clopper-Pearson confidence interval
Duration of the obturation procedure Summary statistics mean median max min IQR and range will be reported
Questionnaire about the quality and usability of the device
Summary statistics of results will be reported
Sample Size In order to be able to establish non-inferiority within a margin of 02 of the target rates of 085 a two-sided 95 confidence interval for the healing rate must lie above 085 - 02 065 Assuming a pessimistic scenario where the true underlying healing rate of the Endofill device is 002 lower than the target rate of 085 ie 083 data from 56 participants are needed This yields a power of 80 for the study Assuming a 10 drop out rate at 12 months the required sample size is 63
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None