NCT06715774

Brief Summary

Analyse the impact Twin block appliance and Motion on Hyoid Bone

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

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

February 7, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

2 days

First QC Date

November 28, 2024

Last Update Submit

November 28, 2024

Conditions

Keywords

Hyoid bone, twin block, motion,

Outcome Measures

Primary Outcomes (1)

  • Impact of Twin Block and Motion Class II Appliances on Hyoid Bone Position - A Retrospective Clinical Study

    See the impact of twin block and motion on the hyoid bone

    2023-2024

Interventions

All patients were submitted to preoperative and postoperative lateral teleradiography (Vatech D052SB, Puteaux, France), with the following exposure parameters: 75KV, Intensity10mA, exposition times 11s28, 112,8 mAs, using the Frankfort plane as reference parallel to the floor; moreover, patients were required to avoid moving and swallowing. Afterwards, digital datasets were uploaded and aligned into a digital therapeutic planning software (Orthalis®, Orqualceph®,group orqual) to accurately record the position changes of the hyoid bone at horizontal, vertical, and angular level, according the gender, facial biotype and airway complex, by measuring the following anatomical references:

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children bewten 10-16 years old

You may qualify if:

  • and 16 years old, with sketelal class II, a ANB angle ≥4° according to the Steiner cephalometric analysis, with Twin block or Motion appliance

You may not qualify if:

  • without previous orthodontic treatment, without systemic disesases and adenotonsillar hypertrophy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salamanca

Salamanca, 37008, Spain

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Romane Gilbert

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 4, 2024

Study Start

February 7, 2023

Primary Completion

February 9, 2023

Study Completion

June 25, 2024

Last Updated

December 4, 2024

Record last verified: 2024-11

Locations