Hyoid BoneHyoid boneNCT06715774
Impact of Twin Block and Motion Class II Appliances on Hyoid Bone Position - A Retrospective Clinical Study
An observational study of Hyoid Bone, run by University of Salamanca at 1 site in Spain.
Trial summary
Analyse the impact Twin block appliance and Motion on Hyoid Bone Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyoid Bone
- What is being tested?
- Impact of Twin Block and Motion above Hyoid bone
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- 7 Feb 2023to 25 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children bewten 10-16 years old
Who may be able to join
- 10 and 16 years old, with sketelal class II, a ANB angle ≥4° according to the Steiner cephalometric analysis, with Twin block or Motion appliance
Who cannot join
- without previous orthodontic treatment, without systemic disesases and adenotonsillar hypertrophy.
Trial locations and contacts
1 site in 1 country.
About this study
Analyse the impact Twin block appliance and Motion on Hyoid Bone
Read the detailed description
Patients were selected, divided en two homogenous groups and underwent preoperative and postoperative lateral teleradiograph scans. The datasets were subsequently uploaded into a digital treatment planning software to record the position changes of the hyoid bone at horizontal, vertical, angular, and airway complex level; additionally, the effect of gender, age at onset, treatment time, biotype, and their interactions with the group, have been also statistically evaluated.
- Conditions
- Hyoid Bone
- Being tested
- Impact of Twin Block and Motion above Hyoid bone
- Keywords
- Hyoid bone, twin block, motion,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of Twin Block and Motion above Hyoid boneDevice
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:
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2023-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start7 Feb 2023
- Primary completion9 Feb 2023
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyoid BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER MONTERO, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715774
- Sponsor's protocol ID
- RG-2024-ortho
- Acronym
- Hyoid bone
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Twin Block and Motion Class II Appliances on Hyoid Bone Position - A Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT06715774
- Acronym / sponsor ID
- Hyoid bone / RG-2024-ortho
- Conditions
- Hyoid Bone
- Keywords
- Hyoid bone, twin block, motion,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analyse the impact Twin block appliance and Motion on Hyoid Bone
Detailed description
Patients were selected, divided en two homogenous groups and underwent preoperative and postoperative lateral teleradiograph scans. The datasets were subsequently uploaded into a digital treatment planning software to record the position changes of the hyoid bone at horizontal, vertical, angular, and airway complex level; additionally, the effect of gender, age at onset, treatment time, biotype, and their interactions with the group, have been also statistically evaluated.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children bewten 10-16 years old
Key inclusion criteria (1 listed)
- 10 and 16 years old, with sketelal class II, a ANB angle ≥4° according to the Steiner cephalometric analysis, with Twin block or Motion appliance
Key exclusion criteria (1 listed)
- without previous orthodontic treatment, without systemic disesases and adenotonsillar hypertrophy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of Twin Block and Motion above Hyoid boneAll 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: | Device | – |
Primary outcome
Impact of Twin Block and Motion Class II Appliances on Hyoid Bone Position - A Retrospective Clinical Study
Time frame: 2023-2024
See the impact of twin block and motion on the hyoid bone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyoid Bone, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Twin Block and Motion Class II Appliances on Hyoid Bone Position - A Retrospective Clinical Study (time frame: 2023-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.