Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753138
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2021-01-26
Brief Title:
Outcome of SBO With Calcium Silicate Sealer vs WVC With Resin Based Sealer
Sponsor:
Kuwait Institute for Medical Specialization
Organization:
Kuwait Institute for Medical Specialization
Study Overview
Official Title:
The Outcome of Non-surgical Root Canal Treatment Using Sealer-based Obturation With Calcium Silicate Sealer vs Warm Vertical Compaction With AH Sealer A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-12
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:
A single blinded randomized controlled trial 212 subjects teeth 106 in each of the 2 groups will be recruited from the patients referred to Kuwait Board of Endodontics for primary root canal treatment The aim is to compare the outcome of sealer-based obturation SBO with calcium silicate sealer versus warm vertical compaction WVC and resin based sealer
Preoperative PA radiograph and CBCT will be taken A 1 year follow up period will be arranged and another PA radiograph and CBCT will be taken The preoperative postoperative and review clinical and radiographic data will be analyzed
Preoperative PA radiograph and CBCT will be taken A 1 year follow up period will be arranged and another PA radiograph and CBCT will be taken The preoperative postoperative and review clinical and radiographic data will be analyzed
Detailed Description:
Aims and Objectives
To compare the clinical outcome of the SBO with WVC in non-surgical root canal treatment
To compare the radiographic outcome of the SBO with WVC in non-surgical root canal treatment using periapical radiographs and CBCT scans
To assess the difference in postoperative pain between the 2 groups
To assess the difference in the time required to complete the obturation between the 2 groups
Materials and Methods
Patients who are referred to the Kuwait Board of Endodontics for non-surgical root canal treatment and fulfil the inclusionexclusion criteria of the study will be included
Pre-operative periapical radiograph CBCT scan and 11-point Numerical Rating Scale NRS will be taken
Upon completion of root canal instrumentation the participants will be randomly allocated to either Group A obturation using SCCS or Group B obturation using WVC The participants will be blinded to the type of treatment received and the clinician will only be informed of the obturation method once the canalcanals are ready for obturation
All teeth will then be restored definitively
The participants will be contacted via telephone 1 3 and 7 days post-treatment to report their NRS pain score
The participants will be recalled after 1 year for clinical and radiographic assessment using periapical radiograph and CBCT scan
The participants will then be followed-up annually for up to 4 years
Statistical analysis will be performed
The design of the study will conform to the CONSORT statement
Statistical and Analytical Plans
Sample size estimation for the treatment outcome was performed using PASS 2019 computer software utilizing information from previous studies on healing outcome after initial endodontic therapy For a two independent-samples t-test of proportions at power of 80 and 5 significance level for two-tailed test detecting a 10 difference of healing rate required a sample size of 148 teeth Adjusting for a dropout rate of 30 the required sample size was 212 teeth The slightly high 30 dropout rate is anticipated because most of the patients we treat are non-Kuwaiti nationals and their presence in the country after 1 year is not guaranteed
To compare the clinical outcome of the SBO with WVC in non-surgical root canal treatment
To compare the radiographic outcome of the SBO with WVC in non-surgical root canal treatment using periapical radiographs and CBCT scans
To assess the difference in postoperative pain between the 2 groups
To assess the difference in the time required to complete the obturation between the 2 groups
Materials and Methods
Patients who are referred to the Kuwait Board of Endodontics for non-surgical root canal treatment and fulfil the inclusionexclusion criteria of the study will be included
Pre-operative periapical radiograph CBCT scan and 11-point Numerical Rating Scale NRS will be taken
Upon completion of root canal instrumentation the participants will be randomly allocated to either Group A obturation using SCCS or Group B obturation using WVC The participants will be blinded to the type of treatment received and the clinician will only be informed of the obturation method once the canalcanals are ready for obturation
All teeth will then be restored definitively
The participants will be contacted via telephone 1 3 and 7 days post-treatment to report their NRS pain score
The participants will be recalled after 1 year for clinical and radiographic assessment using periapical radiograph and CBCT scan
The participants will then be followed-up annually for up to 4 years
Statistical analysis will be performed
The design of the study will conform to the CONSORT statement
Statistical and Analytical Plans
Sample size estimation for the treatment outcome was performed using PASS 2019 computer software utilizing information from previous studies on healing outcome after initial endodontic therapy For a two independent-samples t-test of proportions at power of 80 and 5 significance level for two-tailed test detecting a 10 difference of healing rate required a sample size of 148 teeth Adjusting for a dropout rate of 30 the required sample size was 212 teeth The slightly high 30 dropout rate is anticipated because most of the patients we treat are non-Kuwaiti nationals and their presence in the country after 1 year is not guaranteed
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?:
None
Is an FDA AA801 Violation?:
None