Mini-implant-supported Twin-Block in Treating Patients With Class II Division 1 Malocclusion

May 7, 2024 updated by: Damascus University

Evaluation of the Skeletal and Dentoalveolar Effects of Mini-implant-supported Twin-Block in Treating Growing Patients With Class II Division 1 Malocclusion: A Two-arm Randomized Controlled Clinical Trial

Correcting the skeletal class II using functional appliances, whether removable or fixed, always leads to skeletal and alveolar effects. However, some of these effects are unfavorable, the most significant being the loss of support in the lower dental arch. This loss of support leads to an uncontrolled labial inclination of the lower incisors and mesial movement of the lower; these dentoalveolar effects impact the degree of skeletal correction that can be achieved. Therefore, this study aimed to evaluate the skeletal and dentoalveolar effects following the use of a mini-implant-supported Twin-Block appliance compared to the conventional Twin-Block.

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

Many attempts have been made to modify the Twin-Block appliance to decrease the dentoalveolar effects, such as omitting the upper labial bow, including torquing spurs on the upper incisors, and adding acrylic capping on the lower incisors. However, these modifications have not been successful in eliminating the dentoalveolar effects. This is because the Twin-Block and other functional appliances are supported by teeth rather than bone. As a result, the components of the appliance exert force on the teeth while the mandible attempts to return to its natural resting position. No previous clinical trial described the use of the Twin-Block appliance supported by orthodontic mini-implants and the potential benefits of using mini-implants with Twin-Block in functional treatment.

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.
41

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

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20 HAJ72
        • Department of Orthodontics, Faculty of Dentistry, University of Damsacus

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The wrist radiograph (stage 4 S and stage 5 MP3 cap)
  2. Skeletal Class II division 1 malocclusion caused by mandibular retrusion
  3. ANB (5°- 9°)
  4. SNB (72°- 77°)
  5. overjet (5 - 8 mm),
  6. Minimal crowding in dental arches (≤ 3 mm),
  7. MM≤30°
  8. lower second molars erupting.

Exclusion Criteria:

  1. Previous orthodontic procedures.
  2. Systemic diseases.
  3. Temporal Mandibular Joint disorders.
  4. Poor oral hygiene

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
  • Masking: Single

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: Mini-implant-supported Twin-Block
Treatment will be done using the Mini-implant-supported Twin-block appliance until the correction is achieved.
Device: Mini-implant-supported Twin-Block
Mini-implants will support the Twin-Block appliance during the functional treatment.
Active Comparator: Conventional Twin-Block group
Treatment will be done using the Twin-block appliance until the correction is achieved.
Device: Twin-Block
This is the main appliance that will be used to correct the Class II deformity.

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 the overjet
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the labial surface of the lower central incisor (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the overbite
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured vertically from the upper to the lower central incisors' edges (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the molar relationship
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the maxillary first permanent molar to the mesial cusp of the mandibular first permanent molar (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the position of the maxillary base
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to a vertical reference plane (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the position of the mandibular base
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from Pogonion Point to a vertical reference plane (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the mandibular position relative to the upper jaw
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to Pogonion Point (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in condylar head position
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion point to the vertical reference plane (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the composite mandibular length
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion Point to the Pogonion Point (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the maxillary incisor
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the A Point (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the mandibular incisor
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the lower central incisor edge to the Pogonion Point (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the maxillary permanent first molar
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the maxillary first permanent molar to A Point (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the mandibular permanent first molar
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the mandibular first permanent molar to the Pogonion Point (in mm).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the ramus height
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. The distance was measured vertically from the Articular Point (Ar) to the Gonion Point (Go) in millimeters.
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the corpus length
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This was measured sagittally from the Gonion (Go) Point to the Mention (Me) Point. The distance is measured in mm.
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in MM angle
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. It is calculated for the internal angle formed by the intersection between the maxillary and mandibular planes.
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the SN-OP
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the occlusal plane (OP) and the anterior cranial base (the distance between Sella (S) and Nasion (N)) in the vertical direction.
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the SN-MP
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient This angle, measured in degrees, represented the relationship between the lower jaw plane and the cranial base in the vertical direction.
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the Bjork sum (N-S-Ar + S-Ar-Go +Ar-Go-Me)
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, was the sum of three angles: the saddle angle (N-S-Ar angle), the articular angle (S-Ar-Go), and the gonial angle (Ar-Go-Me).
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the inclination of the upper incisors.
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the upper incisor axis and the anterior cranial base in the anteroposterior direction. It was measured between the upper incisor axis and the SN plane.
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the L1-MP angle
Time Frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the lower incisor axis and the mandibular base in the anteroposterior direction. It was measured between the lower incisor axis and the Go-Me plane.
T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 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.
Damascus University

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: Rabea A Ghareeb, DDS, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
  • Study Director: Kinda Sultan, DDS MSc PhD, Department of Orthodontics, Faculty of Dentistry, Damascus University
  • Study Chair: Mohammad Y Hajeer, DDS MSc PhD, Department of Orthodontics, Faculty of Dentistry, Damascus University

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 (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.
September 10, 2022

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.
November 27, 2023

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.
December 26, 2023

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).
May 3, 2024

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 3, 2024

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 7, 2024

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.
May 9, 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.
May 7, 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.
May 1, 2024

More Information

Terms related to this study

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.
  • UDDS-Ortho-3-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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