NCT05173402

Brief Summary

The primary purpose of this study was to evaluate the immediate and previous results of the effectiveness of non-surgical orthopedic treatment in children aged 12-14 years with gnathic forms of mesial occlusion by the method of dentoalveolar compensation using a permanent apparatus with a palatal expanding screw.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

6.1 years

First QC Date

December 14, 2021

Last Update Submit

December 23, 2021

Conditions

Keywords

early adolescenceorthodontic practiceorthodontic treatment

Outcome Measures

Primary Outcomes (2)

  • dentoalveolar compensation method

    orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw

    2014-2020

  • face mask

    orthopedic treatment was performed using a face mask

    2014-2020

Study Arms (2)

The experimental group

The experimental group included 26 patients - orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw.

Device: dentoalveolar compensation method

The comparison group

The comparison group included 20 patients - orthopedic treatment was performed using a face mask.

Device: face mask

Interventions

orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw

The experimental group
face maskDEVICE

orthopedic treatment was performed using a face mask.

The comparison group

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

To evaluate the early and late results of the non-surgical orthopedic treatment efficiency in 12-14 years old children with the gnathic forms of mesial occlusion by the dentoalveolar compensation utilizing a permanent device with a palatal expanding screw.

You may qualify if:

  • patients with a gnathic (skeletal) mesial occlusion patients age 12-14 years patients who underwent orthopedic treatment

You may not qualify if:

  • change of residence severe form of gnathic mesial occlusion congenital anomalies of the dento-maxillo-facial area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Masks

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., Associate Professor

Study Record Dates

First Submitted

December 14, 2021

First Posted

December 29, 2021

Study Start

September 5, 2014

Primary Completion

October 5, 2020

Study Completion

October 5, 2020

Last Updated

December 29, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

The study was anonymous. No personal data will be revealed