An Evaluation of Root Length Measurements Using Intraoral... | NCT02822040

Studies
An Evaluation of Root Length Measurements Using Intraoral Scan and Panoramic Radiographs

NCT02822040

Sponsor

Loma Linda University

Status

Completed

Last Update Posted

Sep 20, 2016Estimated

Enrollment

21Actual

Phase

Not provided

Conditions

Root Resorption

Interventions

Intraoral Scan

Countries

Not provided

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

Sep 2016

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

Jul 2016

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Apr 18, 2016

First Submission Date that Met QC Criteria

Jun 29, 2016

First Posted Date

Jul 4, 2016Estimated

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

Sep 19, 2016

Last Update Posted Date

Sep 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study will attempt to validate a method of estimating root length on panoramic radiograph by crown measurement on intraoral digital scans.

Detailed Description

Intraoral digital scans will be taken on patients who have completed orthodontic treatment, and measurements will be made on the crown dimensions. These dimensions will then be applied onto the same teeth as seen on panoramic radiographs and a mathematical relationship will be determined for root length. Changes in root length will be measured from initial records to treatment complete panoramic radiographs and these estimates will be compared to actual root length changes as measured in CBCT (Cone Beam Computed Tomography) records.

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

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group		All patients who have initial and final records qualify in the experimental group.	Other: Intraoral Scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraoral Scan	Other	All patients will have an intraoral scan performed for measurements to be taken on.	Experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in root length in mm	Changes in root length will be calculated, starting from the initiation of orthodontic treatment to completion of treatment, at an average of 24 months.	Root length will be measured at the initiation of orthodontic treatment and at an average of 24 months later.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has initial records including CBCT scan and panoramic radiograph that are clear. Subject must have no restorations or significant loss in tooth structure in target teeth or teeth adjacent to target.

Exclusion Criteria:

Subjects who have records that are not clear, and who are missing target teeth.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Patients who have undergone orthodontic treatment, and associated tooth movement, and have initial records directly before the initiation of treatment.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rodrigo Viecilli, DDS, PhD	Loma Linda University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012391	Root Resorption

Ancestor Terms

ID	Term
D014091	Tooth Resorption
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided