Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skeletal Patterns

July 20, 2024 updated by: VANDE VANNET Bart, Central Hospital, Nancy, France

Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skeletal Patterns in Adult Patients: Retrospective Study.

The objective is to compare the dento-alveolar therapeutic effects of wearing class II inter-arch traction elastics on aligners versus multi-brackets in an adult population. The principal hypothesis is no significant difference in therapeutic effects of using inter-arch elastics on aligners versus multi-brackets.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is a non-interventional research involving the human person, research on existing data and / samples in the field of dentofacial orthopedics. This study analyzes the effects of rubber bands when combined with aligners in adult patients. This is a comparative retrospective study of radiographs and casts before and after orthodontic treatment. The patients studied are in Angle class II and adults. Two groups are analysed: patients treated with fixed (vestibular multi-attachment) and removable (Invisalign-type aligners) appliances.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Lorraine
      • Nancy, Lorraine, France, 54000
        • DEON
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adult with class II malocclusion treated with class II elastics

Description

Inclusion Criteria:

  • CVM stage 5 on lateral teleradiography (end of growth)
  • Angle Class II
  • Treatments with rubber bands for inter-arch traction
  • End of treatment in class I

Exclusion Criteria:

  • Incomplete data
  • Treatment with extractions, mini-screws, mini-plate or ortho-surgical treatment
  • Dental agenesis (excluding wisdom teeth)
  • Cranial-facial syndromes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Clear aligner
Patient with class II malocclusion, treated with class II elastics on aligners
Combination product: Aligner and inter-arch elastics
Correction of class II malocclusion by class II elastics on clear aligners
Fixed appliance
Patient with class II malocclusion, treated with class II elastics on fixed appliance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in IMPA Mandibular incisor angle (degrees)
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months.
Angle between the mandibular plane and the lower incisor axis: position of the lower incisor in relation to the mandible
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sex
Time Frame: 1 month
Sex
1 month
Duration of treatment
Time Frame: 24 months
Treatment time duration in month
24 months
Change in interproximal dental size
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Interproximal size in mm
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal sagittal pattern ANB angle
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Cephalometric measurements : angle between A, Na (nasion) and B in degrees
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal sagittal pattern Ao-Bo
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Cephalometric measurements : mesure in mm between Ao and Bo
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal vertical pattern : FMA
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Cephalometric measurements : angle in degrees between franckfort plan and mandibular plan.
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal vertical pattern : Sn Gogn
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Cephalometric measurements : angle in degrees between SN and GoGn
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in faciale anterior height
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Cephalometric measurements of faciale anterior height
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in faciale posterior height
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Cephalometric measurements of faciale posterior height
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in index Faciale height
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Cephalometric measurements, index HFP (faciale posterior heigth)/ HFA (faciale anterior height)
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in nterincisal angle
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Cephalometric measurements : measurement between manxillary and mandibular incisors.
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in plan of occlusion
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Cephalometric measurements : angle between SN and Op
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Age at the beginning of treatment
Time Frame: 1 month
Age
1 month
Age at the end of treatment
Time Frame: 24 months
Age
24 months
Change in von Spee curve
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Measurements on impressions : it is the average of the distance between the highest point of the deepest cusp and the occlusal plane.
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overall crowding
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Measurements on impressions : comparison of the sum of the mesiodistal diameters of 35 to 45 and the arch perimeter from the mesial face of 36 to the mesial face of 46.
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overjet
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Measurements on impressions : in mm
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overbite
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Measurements on impressions : in mm
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in arch length
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Measurements on impressions : distance between inter incisal point and mesiale face of 6.
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
CHange in class II quantity
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Measurements on impressions : inter canine and inter molar relations
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in space required
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Measurements on impressions : sum of all mesiodistal diameter.
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter canine distance
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Measurements on impressions : distance between the canine in mm
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter premolar distance
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Measurements on impressions : distance between the premolars
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter molar distance
Time Frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Measurements on impressions : distance between the molars
First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bart Vande Vannet, Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023PI022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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