Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05847738
Status:
COMPLETED
Last Update Posted:
2023-05-08
First Post:
2023-04-19
Brief Title:
Post-operative Pain With Different Apical Finishing Sizes After Single Visit Root Canal Treatment
Sponsor:
British University In Egypt
Organization:
British University In Egypt
Study Overview
Official Title:
Comparative Evaluation of Post-operative Pain With Different Apical Finishing Sizes After Single Visit Root Canal Treatment
Status:
COMPLETED
Status Verified Date:
2023-05
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:
This is a randomized controlled parallel clinical prospective split mouth triple blinded study Sample size calculation was conducted and it was 25 subjects per group for a total of 50 sides to compensate for drop-outs
Patient selection and preparation
All root canal treatments were performed by a single endodontic consultant All subjects were selected from walk in patients presented to the endodontic clinic of the British university in Egypt Cases that met the inclusion criteria where selected for this study All patients were verbally informed about the procedures benefits and that the results of the treatment will be used to this study and the risks of the procedure was explicitly explained to them After the verbal consent patients were handed a written form consent to sign upon
All data of post-operative pain were recorded by a second blinded clinician through a visual analog scale VAS Post-operative monitoring periods will be recorded in 12 hours 24 hours 3 days and one week Data was sent to the statistician with group names only to fulfill the triple blinding criteria and results will be interpreted
Patient selection and preparation
All root canal treatments were performed by a single endodontic consultant All subjects were selected from walk in patients presented to the endodontic clinic of the British university in Egypt Cases that met the inclusion criteria where selected for this study All patients were verbally informed about the procedures benefits and that the results of the treatment will be used to this study and the risks of the procedure was explicitly explained to them After the verbal consent patients were handed a written form consent to sign upon
All data of post-operative pain were recorded by a second blinded clinician through a visual analog scale VAS Post-operative monitoring periods will be recorded in 12 hours 24 hours 3 days and one week Data was sent to the statistician with group names only to fulfill the triple blinding criteria and results will be interpreted
Detailed Description:
This is a randomized controlled parallel clinical prospective split mouth triple blinded study Sample size calculation was conducted using GPower 3194 software based on data obtained from a previous study It was estimated that a minimum sample size of 19 subjects sides per group for a total of 38 sides would be essential for an effect size of 097 with an alpha error of 005 and a power beta of 090 to achieve 95 confidence of a true difference between the groups Sample size was increased by 25 to 25 subjects per group for a total of 50 sides to compensate for drop-outs
Patient selection and preparation
All root canal treatments were performed by a single endodontic consultant All subjects were selected from walk in patients presented to the endodontic clinic of the British university in Egypt Cases that were diagnosed and did not meet the inclusion criteria were referred to the intern clinic for dental care Cases that met the inclusion criteria where selected for this study All patients were verbally informed about the procedures benefits and that the results of the treatment will be used to this study and the risks of the procedure was explicitly explained to them After the verbal consent patients were handed a written form consent to sign upon
Procedure
Radiographs were taken by a Paralleled long cone periapical radiography To ensure a visible root canal 30 of canal curvature and a periapical index PAI score of 3-5 in addition of initial confirmation of root canal types All patients were anesthetized rubber dam applied and access cavities were performed After root canal exploration and scouting root canal systems were reconfirmed to be the types selected for this study
Initial binding file was selected for all root canals to ensure it met the inclusion size of mesial roots 20 and distal 30 After patency and glide path were performed by K-files up to size 20 engine driven canal enlargement was applied using E3 Azure files to final finishing size according to the grouping
Group A left side of the patient were prepared 2 sizes larger than the IBF to size 3504 mesial canals and 4004 distal canals
Group B right side of the patient were prepared 3 sizes larger than the IBF to size 4004 mesial canals and 4504 distal canals
All data of post-operative pain were recorded by a second blinded clinician through a visual analog scale VAS Post-operative monitoring periods will be recorded in 12 hours 24 hours 3 days and 1 week
Data was sent to the statistician with group names only to fulfill the triple blinding criteria and results will be interpreted
Patient selection and preparation
All root canal treatments were performed by a single endodontic consultant All subjects were selected from walk in patients presented to the endodontic clinic of the British university in Egypt Cases that were diagnosed and did not meet the inclusion criteria were referred to the intern clinic for dental care Cases that met the inclusion criteria where selected for this study All patients were verbally informed about the procedures benefits and that the results of the treatment will be used to this study and the risks of the procedure was explicitly explained to them After the verbal consent patients were handed a written form consent to sign upon
Procedure
Radiographs were taken by a Paralleled long cone periapical radiography To ensure a visible root canal 30 of canal curvature and a periapical index PAI score of 3-5 in addition of initial confirmation of root canal types All patients were anesthetized rubber dam applied and access cavities were performed After root canal exploration and scouting root canal systems were reconfirmed to be the types selected for this study
Initial binding file was selected for all root canals to ensure it met the inclusion size of mesial roots 20 and distal 30 After patency and glide path were performed by K-files up to size 20 engine driven canal enlargement was applied using E3 Azure files to final finishing size according to the grouping
Group A left side of the patient were prepared 2 sizes larger than the IBF to size 3504 mesial canals and 4004 distal canals
Group B right side of the patient were prepared 3 sizes larger than the IBF to size 4004 mesial canals and 4504 distal canals
All data of post-operative pain were recorded by a second blinded clinician through a visual analog scale VAS Post-operative monitoring periods will be recorded in 12 hours 24 hours 3 days and 1 week
Data was sent to the statistician with group names only to fulfill the triple blinding criteria and results will be interpreted
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