Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the... | NCT05519462

Studies
Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar, a Feasible Choice?

NCT05519462

Sponsor

Malmö University

Status

Completed

Last Update Posted

Apr 30, 2024Actual

Enrollment

48Actual

Phase

Not provided

Conditions

Teeth; Lesion
Tooth Diseases

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Nov 15, 2020Actual

Completion Date

May 15, 2021Actual

First Submitted Date

Aug 24, 2022

First Submission Date that Met QC Criteria

Aug 25, 2022

First Posted Date

Aug 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2024

Last Update Posted Date

Apr 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar.

CBCT investigations with standard and low dose protocol for evalutation of the mandibular third molar.

Detailed Description

Two CBCT scans were acquired of each examination site: one scan using the standard clinical protocol (90kV, 5mA, 9.4s) and one, the low-dose protocol (90kV, 2mA, 9.4s). All exposures were made with a Veraviewepocs 3D F40 (J Morita Corp.; Kyoto, Japan) using a field of view (FOV) of 4.0 x 4.0 cm and a rotation mode of 180°, voxel size of 0.125 mm.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluation of radiographic images	landmarks	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a need for a CBCT investigation of the mandibula third molar

Exclusion Criteria:

been involved in radiographic examinations for science beforer.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adults

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristina Hellen-Halme, professor	Malmö University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kristina Hellen-Halme		Malmö		20250	Sweden