Root ResorptionNCT02822040

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

An observational study of Root Resorption, run by Loma Linda University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 13 to 55 years
Conditions the study is for: Root Resorption
What is being tested?: Intraoral Scan
How many people: 21 participants
Where: No sites listed yet
Study dates: Jul 2016to Sep 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 55 years
All sexes
No healthy volunteers
Child, Adult

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

Who may be able to join

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.

Who cannot join

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

About this study

Official title: An Evaluation of Root Length Measurements Using Intraoral Scan and Panoramic

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

Read the 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.

Conditions: Root Resorption
Being tested: Intraoral Scan
Keywords: Root Resorption, Panoramic Radiograph
Medical subject headings: Root Resorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intraoral ScanOther
All patients will have an intraoral scan performed for measurements to be taken on.

Study groups in NCT02822040
Study group	Role	What they receive
Experimental group		All patients who have initial and final records qualify in the experimental group. Receives: Other: Intraoral Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Root length will be measured at the initiation of orthodontic treatment and at an average of 24 months later.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016Sep 2016

First posted4 Jul 2016 (estimated)
Study startJul 2016
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Root ResorptionStudies of the same condition, open and under way.
More trials run by Loma Linda UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02822040
Sponsor's protocol ID: 5160149
Status last verified: Sep 2016
First submitted: 18 Apr 2016
Last updated: 20 Sep 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitation
Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
Pain, Postoperative, Root Resorption
Active, not recruiting
Effects of PBM on Fixed-appliance Orthodontic Patients
Orthodontics, Root Resorption
Recruiting
3-D Evaluation of Alveolar Bone Changes and Root Resorption After Traction of Buccally Displaced Maxillary Canines
Malocclusion; Displaced Teeth
RecruitingObservational study
Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
Dental Restoration, Permanent, Dental Restorations
Recruiting
Maxillary Incisor Intrusion Using Utility Arch Assisted With Micro-osteoperforations
Deep Bite Malocclusion, Intrusion of Tooth

All Root Resorption trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of Root Length Measurements Using Intraoral Scan and Panoramic
ClinicalTrials.gov ID: NCT02822040
Acronym / sponsor ID: 5160149
Conditions: Root Resorption
Keywords: Root Resorption, Panoramic Radiograph
Study type: Observational
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: Jul 2016
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 4 Jul 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Experimental group	–	Other: Intraoral ScanAll patients who have initial and final records qualify in the experimental group.

Who may qualify

Ages: 13 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Patients who have undergone orthodontic treatment, and associated tooth movement, and have initial records directly before the initiation of treatment.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intraoral ScanAll patients will have an intraoral scan performed for measurements to be taken on.	Other	Experimental group

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
Individual participant dataSharing planned: No

Related trials for Root Resorption

Enrolling by invitation
Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
Pain, Postoperative, Root Resorption
Active, not recruiting
Effects of PBM on Fixed-appliance Orthodontic Patients
Orthodontics, Root Resorption
Recruiting
3-D Evaluation of Alveolar Bone Changes and Root Resorption After Traction of Buccally Displaced Maxillary Canines
Malocclusion; Displaced Teeth
RecruitingObservational study
Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
Dental Restoration, Permanent, Dental Restorations
Recruiting
Maxillary Incisor Intrusion Using Utility Arch Assisted With Micro-osteoperforations
Deep Bite Malocclusion, Intrusion of Tooth

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rodrigo Viecilli, DDS, PhD principal investigator

Loma Linda University

Questions about this trial

What is this clinical trial studying?

An observational study of Root Resorption, run by Loma Linda University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in root length in mm (time frame: Root length will be measured at the initiation of orthodontic treatment and at an average of 24 months later.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02822040.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.