Comparison Between 2 Protocols for the Treatment of Class II Division 2 Malocclusion

February 20, 2019 updated by: Mahmoud abuaysheh, Jordan University of Science and Technology

A Prospective Randomized Clinical Trial to Compare Between Two Leveling and Alignment Protocols for the Treatment of Class II Division 2 Malocclusion

The aim of this prospective study was to compare between two different treatment modalities of class II division 2; to start treatment in upper arch first until adequate overjet is obtained or to start in the lower arch first with removable anterior bite plane in upper arch.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Fifty four subjects with class II division 2 participated in this study. The subjects were randomly divided into two groups; Group one (28 patients): orthodontic treatment with upper arch bond up first and lower arch was bonded when 4 mm overjet was reached. The treatment continued until 0.019 x 0.025 " stainless steel wires were reached in both arches. Group 2 (26 patients): orthodontic treatment with lower arch bond up first with removable anterior bite plane in upper arch. When 0.019 x 0.025" stainless steel wire was reached, the upper arch was bonded. The treatment continued until 0.019 x 0.025" stainless steel wires were reached. Three cephalograms were taken for each patient in both groups; pretreatment (T0) , after bonding the other arch (T1) and at the end of leveling and alignment in both arches (T2). Cephalometric measurements and superimpositions were made. Skeletal and dentoalveolar treatment changes were compared within and between the 2 groups.

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.
Interventional

Enrollment (Actual)

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.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Jordan
      • Irbid, Jordan
        • Jordan University of science and technology Dental Teaching Clinics

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

17 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 17 years and ≤ 26 years
  • Class II division 2 malocclusion.
  • Overjet (OJ) < 4 mm.
  • Overbite (OB) covering more than half of the lower incisor height.
  • Mild to moderate crowding with tooth contact displacement no more than 2 mm.
  • Good oral hygiene and healthy periodontium.

Exclusion Criteria:-

  • Systemic health problems and medications were taken.
  • History of previous orthodontic treatment.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Upper Arch Treatment First

Intervention : using fixed orthodontic pre-adjusted edgewise appliance in the upper and lower arches.

starting treatment in the upper arch The upper ach was bonded for 28 patients and teeth alignment was started using round 0.014"NiTi arch wire. The 0.014"NiTi arch wire was placed into the slots of the brackets and tied with elastomers by figure of 8. Orthodontic treatment was continued in the upper arch with arch wire sequence of 0.014"NiTi, 0.018"NiTi, 0.016"X0.022"NiTi, 0.019"X0.025"NiTi, and 0.019"X0.025"stainless steel arch wires. The patients were followed up on a monthly basis until sufficient proclination of the upper incisors achieved to establish an overjet of at least 4 mm. After reaching the full working arch wire in lower arch (0.019" X 0.025"stainless steel wire), lateral cephalogram and study models were taken.
Device: Fixed appliance
Experimental: Lower Arch Treatment First

Intervention : using fixed orthodontic pre-adjusted edgewise appliance in the lower arch and anterior bite plate in the upper arch.

The lower arch was bonded after taking the pretreatment records. At the same appointment an anterior bite plate in the upper arch was delivered to prevent shearing off the mandibular incisor brackets and help in correction of anterior deep bite .After lower arch alignment and leveling in the same arch wire sequence as the other group and 0.019" X 0.025"stainless steel arch wire was reached, the anterior bite plate was removed and the upper arch was bonded. The same arch wire sequence was used in the upper arch as was used in the lower arch. When the full working arch wire (0.019" X 0.025"stainless steel arch wire) was reached in the upper arch, study models and lateral cephalogram were taken.
Device: 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
Upper and lower incisors proclination
Time Frame: 2 years
Cephalometric analysis. Treatment changes in the values for upper and lower incisors in degrees, Upper incisor /Maxillary plane in degrees and lower incisors/Mandibular plane in degrees.
2 years

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
Duration of treatment
Time Frame: 2 years
Measurements of time of treatment in months
2 years
Pain perception
Time Frame: 2 years
Using visual analogue scale. From 0 where is no pain to 10 with severe pain
2 years

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.
Jordan University of Science and Technology

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.
  • Principal Investigator: Susan AlKhateeb, PhD, Jordan University of Science and Technology

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 (Actual)

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.
June 1, 2016

Primary Completion (Actual)

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.
January 1, 2018

Study Completion (Actual)

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.
November 1, 2018

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).
February 6, 2019

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.
February 6, 2019

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.
February 7, 2019

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.
February 21, 2019

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.
February 20, 2019

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.
February 1, 2019

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.
  • 461/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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