Back to resultsPost Operative Pain Assessment After Pulpectomy of Primary Molars With Two Different Rotary Systems
Primary Purpose
Pulp Necroses
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pulpectomy using single file system ( One Shape file)
Pulpectomy using single file system ( WaveOne Gold file)
Sponsored by
About this trial
This is an interventional other trial for Pulp Necroses
Eligibility Criteria
Inclusion Criteria:
- Age of more than 4 years
- Healthy children
- Primary molars with irreversible pulp damage
Exclusion Criteria:
- Presence of periapical radiolucency realtes to primary molar
- Uncooperative child
Sites / Locations
- Minia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Wave One Gold
One shape
Arm Description
Receporcating single file used for preparation of root canals in primary molars
Rotation single file used for preparation of root canals in primary molars
Outcomes
Primary Outcome Measures
Post operative pain
Assessment of pain using 4 piont intensity scale
1 means no pain, 2 means slight pain, 3 means moderate pain and for means sever pain at 6,12, 48,72 hours and 1 week
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05057325
Brief Title
Post Operative Pain Assessment After Pulpectomy of Primary Molars With Two Different Rotary Systems
Official Title
Post Operative Pain After Pulpectomy of Primary Molars With One Shap Rotation File Versus Wave One Reciprocating File
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation of post operative pain after pulpectomy procedures for primary molars with irreversible pulp damage and without periapical radulicency using two different systems (One shape file ( ratation movemont) and wave one gold file ( reciprocation movement)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Necroses
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wave One Gold
Arm Type
Experimental
Arm Description
Receporcating single file used for preparation of root canals in primary molars
Arm Title
One shape
Arm Type
Experimental
Arm Description
Rotation single file used for preparation of root canals in primary molars
Intervention Type
Other
Intervention Name(s)
Pulpectomy using single file system ( One Shape file)
Intervention Description
Rotary file instrument for pulpectomy of primary molars ( One shape file)
Intervention Type
Other
Intervention Name(s)
Pulpectomy using single file system ( WaveOne Gold file)
Intervention Description
Rotary file instrument for pulpectomy of primary molars ( WaveOne Gold file)
Primary Outcome Measure Information:
Title
Post operative pain
Description
Assessment of pain using 4 piont intensity scale
1 means no pain, 2 means slight pain, 3 means moderate pain and for means sever pain at 6,12, 48,72 hours and 1 week
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age of more than 4 years
Healthy children
Primary molars with irreversible pulp damage
Exclusion Criteria:
Presence of periapical radiolucency realtes to primary molar
Uncooperative child
Facility Information:
Facility Name
Minia University
City
Minya
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Post Operative Pain Assessment After Pulpectomy of Primary Molars With Two Different Rotary Systems
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