Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432699
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-23
Brief Title:
Rate of Canine Retraction and Pain Perception Following Micro-osteoperforation- a Split Mouth Clinical Study
Sponsor:
Foundation University Islamabad
Organization:
Foundation University Islamabad
Study Overview
Official Title:
Rate of Canine Retraction and Pain Perception Following Micro-osteoperforation- a Split
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
MOPS
Brief Summary:
DEFINITION A short description of clinical study including a brief statement of clinical studys hypothesis written in language intended for the lay public Limit 5000 CHARACTERS
Detailed Description:
Definition Extended description of the protocol including more technical informationas compared to the brief Summary if desired Do not include the entire protocol do not duplicate information recorded in other data elements such as eligibility criteria or outcome measures
Limit32000 characters For Patient Registries Also describe the applicable registry procedures and other quality factors for examples third party certification on site audit In particular summarize any procedures implemented as part of the patient registry including but not limited to the following
Quality assurance plan that addresses data validation and registry procedures including and plans for site monitoring and auditing
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry
Source data verification to assess the accuracy completeness or representativeness of registry data by comparing the data to external data sources for example medical records paper or electronic case reports forms or interactive voice response systems
Data Dictionary that contains detailed descriptions of each variable used by the registry including including the source of the variable coding information if used for example World Health Organization Drug Dictionary MedDRA and normal ranges if relevant
STANDARD OPERATING PROCEDURE TO ADDRESS REGISTRY REGISTRY OPERATIONS AND ANALYSISACTIVITIES SUCH AS PATIENT RECRUITMENT DATA COLLECTIONDATA MANAGEMENT DATA ANALYSIS reporting for adverse events and change management
Sample Size Assessment to specify the number of participants or participate years necessary to demonstrate an effect
Plan for missing data to address situations where variable are reported a missing unavailable non-reported interpretable or considered missing because of data inconsistency or out-of-range results
Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives as specified in the study protocol or plan
Limit32000 characters For Patient Registries Also describe the applicable registry procedures and other quality factors for examples third party certification on site audit In particular summarize any procedures implemented as part of the patient registry including but not limited to the following
Quality assurance plan that addresses data validation and registry procedures including and plans for site monitoring and auditing
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry
Source data verification to assess the accuracy completeness or representativeness of registry data by comparing the data to external data sources for example medical records paper or electronic case reports forms or interactive voice response systems
Data Dictionary that contains detailed descriptions of each variable used by the registry including including the source of the variable coding information if used for example World Health Organization Drug Dictionary MedDRA and normal ranges if relevant
STANDARD OPERATING PROCEDURE TO ADDRESS REGISTRY REGISTRY OPERATIONS AND ANALYSISACTIVITIES SUCH AS PATIENT RECRUITMENT DATA COLLECTIONDATA MANAGEMENT DATA ANALYSIS reporting for adverse events and change management
Sample Size Assessment to specify the number of participants or participate years necessary to demonstrate an effect
Plan for missing data to address situations where variable are reported a missing unavailable non-reported interpretable or considered missing because of data inconsistency or out-of-range results
Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives as specified in the study protocol or plan
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