Anterior CrossbiteNCT06792513
The Effectiveness of Acrylic and Clear Aligners in the Treatment of Anterior Crossbite in Children
A study testing Clear Aligner and Labiolingual Spring Hawley Appliance in people with Anterior Crossbite, run by Ozge Gungor at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the treatment efficacy, treatment duration, and cephalometric changes, as well as the impact on quality of life, of clear aligners and labiolingual spring Hawley appliances in the treatment of pediatric patients with anterior crossbite. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Anterior Crossbite
- What is being tested?
- Clear Aligner and Labiolingual Spring Hawley Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 10 Nov 2024
- Phase
- Interventional
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- In the mixed dentition phase, aged between 7-12 years
- With a dental Class I molar relationship according to Angle's classification
- ANB within the normal range i.e. (the crossbite will be diagnosed as dental)
- Exhibiting anterior crossbite (AC) in at least one permanent incisor in the sagittal plane
- No prior orthodontic treatment for any reason
- No history of maxillofacial trauma
- No systemic diseases or syndromes that may interfere with treatment
- Able to attend regular appointments and cooperate with instructions throughout the treatment process
Who cannot join
- Patients with functional anterior crossbite associated with mandibular functional shift
- Patients with clinically evident retrognathia or prognathia of the maxilla or mandible
- Patients with severe gingivitis or periodontitis
- Patients with known allergies to the materials to be used in the treatment
- Patients with severe dental anomalies (e.g., supernumerary teeth, missing teeth, dental malformations)
- Patients with serious emotional or psychological issues that may hinder treatment compliance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry
Antalya, Konyaaltı, 07058
About this study
Official title: The Effectiveness of Acrylic and Clear Aligners in the Treatment of Anterior Crossbite in Children And Evaluatıon of The Effects of These Treatments on Quality of Life
To evaluate the treatment efficacy, treatment duration, and cephalometric changes, as well as the impact on quality of life, of clear aligners and labiolingual spring Hawley appliances in the treatment of pediatric patients with anterior crossbite.
Read the detailed description
Two groups were treated with clear aligners and labiolingual springs Hawley and the study consisted of 30 patients, 15 patients in each group. Cast analysis and cephalometric analysis were performed at pretreatment and posttreatment. Quality of life was assessed at the end of treatment for both groups.
- Conditions
- Anterior Crossbite
- Being tested
- Clear Aligner, Labiolingual Spring Hawley Appliance
- Keywords
- anterior crossbite, cephalometric analysis, clear aligners, labiolingual spring Hawley, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear AlignerDevice
In this intervention, clear aligners were digitally designed using three-dimensional models for the upper jaw. Attachments were applied to the patients, specifically placed on the incisors exhibiting a crossbite relationship and on the permanent first molars in the posterior region. The series of clear aligners were replaced every 10 days. The aligners were used full-time, except during meals and tooth brushing.
Labiolingual Spring Hawley ApplianceDevice
Also called Z spring appliance
In this intervention, a custom-made labiolingual spring Hawley appliance was designed for the upper jaw. It included two Adams clasps, a vestibular arch, and an active labiolingual spring positioned on the palatal side of the incisor in crossbite. The spring was activated every 10 days. The appliance was used full-time, except during meals and tooth brushing.
| Study group | Role | What they receive |
|---|---|---|
| Clear aligner (group treated with clear aligner) | Experimental | 2 parallel groups one treated with clear aligner and other treated using labiolingual spring Hawley appliances Receives: Device: Clear Aligner |
| Labiolingual spring Hawley appliances (group treated with labiolingual spring Hawley appliances) | Experimental | 2 parallel groups one treated with clear aligner and other treated using labiolingual spring Hawley appliances Receives: Device: Labiolingual Spring Hawley Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cephalometric Measurements Before and After Treatment Assessed Using Dolphin Imaging Software (Version 11.95)
Comparison of cephalometric measurements (e.g., ANB, FMA, U1-NA angle, overjet, and overbite) between the two groups at pre-treatment and post-treatment periods. Measurements will be performed using Dolphin Imaging Software version 11.95, with units reported in degrees and millimeters as applicable.
Measured: 3 months
Changes in Oral Health-Related Quality of Life Assessed Using the Child Oral Health Impact Profile-Short Form 19 (COHIP-SF-19)
COHIP-SF-19 scores will be assessed at the end of the treatment period to evaluate changes in oral health-related quality of life. The scale ranges from 0 to 76, with higher scores indicating worse oral health-related quality of life.
Measured: 3 months
Secondary outcomes (2)
Changes in Analogue Cast Model Measurements Before and After Treatment
Comparison of analogue model measurements, including parameters such as arch depth and arch length, between the two groups at pre-treatment and post-treatment periods. Measurements will be performed using calipers on analogue cast models. Units of measure include millimeters (mm).
Measured: 3 months
3D model measurements
Comparison of the measurements of the 3D digital model analysis of the two groups at the pre-treatment and at the post-treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start10 Jun 2024
- Primary completion10 Jun 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior CrossbiteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ozge Gungor
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University
- Responsible party
- Sponsor-investigator, Ozge Gungor, Akdeniz University
- Investigators
- Özge Güngör, PhD, DDS, Assoc. Prof., Study director, Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792513
- Sponsor's protocol ID
- AUBNG001
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A final decision regarding the sharing of individual participant data (IPD) has not yet been made. Appropriate data-sharing protocols will be evaluated in the future before reaching a decision.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Acrylic and Clear Aligners in the Treatment of Anterior Crossbite in Children And Evaluatıon of The Effects of These Treatments on Quality of Life
- ClinicalTrials.gov ID
- NCT06792513
- Acronym / sponsor ID
- AUBNG001
- Conditions
- Anterior Crossbite
- Keywords
- anterior crossbite, cephalometric analysis, clear aligners, labiolingual spring Hawley, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ozge GungorUniversity, hospital or other
- Collaborators
- Akdeniz University
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 24 Jan 2025 (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.
To evaluate the treatment efficacy, treatment duration, and cephalometric changes, as well as the impact on quality of life, of clear aligners and labiolingual spring Hawley appliances in the treatment of pediatric patients with anterior crossbite.
Detailed description
Two groups were treated with clear aligners and labiolingual springs Hawley and the study consisted of 30 patients, 15 patients in each group. Cast analysis and cephalometric analysis were performed at pretreatment and posttreatment. Quality of life was assessed at the end of treatment for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear aligner (group treated with clear aligner) | Experimental | Device: Clear Aligner2 parallel groups one treated with clear aligner and other treated using labiolingual spring Hawley appliances |
| Labiolingual spring Hawley appliances (group treated with labiolingual spring Hawley appliances) | Experimental | Device: Labiolingual Spring Hawley Appliance2 parallel groups one treated with clear aligner and other treated using labiolingual spring Hawley appliances |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- In the mixed dentition phase, aged between 7-12 years
- With a dental Class I molar relationship according to Angle's classification
- ANB within the normal range i.e. (the crossbite will be diagnosed as dental)
- Exhibiting anterior crossbite (AC) in at least one permanent incisor in the sagittal plane
- No prior orthodontic treatment for any reason
Key exclusion criteria (6 listed)
- Patients with functional anterior crossbite associated with mandibular functional shift
- Patients with clinically evident retrognathia or prognathia of the maxilla or mandible
- Patients with severe gingivitis or periodontitis
- Patients with known allergies to the materials to be used in the treatment
- Patients with severe dental anomalies (e.g., supernumerary teeth, missing teeth, dental malformations)
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 |
|---|---|---|
| Clear AlignerIn this intervention, clear aligners were digitally designed using three-dimensional models for the upper jaw. Attachments were applied to the patients, specifically placed on the incisors exhibiting a crossbite relationship and on the permanent first molars in the posterior region. The series of clear aligners were replaced every 10 days. The aligners were used full-time, except during meals and tooth brushing. | Device | Clear aligner (group treated with clear aligner) |
| Labiolingual Spring Hawley ApplianceAlso: Z spring applianceIn this intervention, a custom-made labiolingual spring Hawley appliance was designed for the upper jaw. It included two Adams clasps, a vestibular arch, and an active labiolingual spring positioned on the palatal side of the incisor in crossbite. The spring was activated every 10 days. The appliance was used full-time, except during meals and tooth brushing. | Device | Labiolingual spring Hawley appliances (group treated with labiolingual spring Hawley appliances) |
Primary outcome
Changes in Cephalometric Measurements Before and After Treatment Assessed Using Dolphin Imaging Software (Version 11.95)
Time frame: 3 months
Comparison of cephalometric measurements (e.g., ANB, FMA, U1-NA angle, overjet, and overbite) between the two groups at pre-treatment and post-treatment periods. Measurements will be performed using Dolphin Imaging Software version 11.95, with units reported in degrees and millimeters as applicable.
Changes in Oral Health-Related Quality of Life Assessed Using the Child Oral Health Impact Profile-Short Form 19 (COHIP-SF-19)
Time frame: 3 months
COHIP-SF-19 scores will be assessed at the end of the treatment period to evaluate changes in oral health-related quality of life. The scale ranges from 0 to 76, with higher scores indicating worse oral health-related quality of life.
2 secondary outcomes
Changes in Analogue Cast Model Measurements Before and After Treatment
Time frame: 3 months
3D model measurements
Time frame: 3 months
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 28 Jan 2025.
- Individual participant dataSharing planned: No. A final decision regarding the sharing of individual participant data (IPD) has not yet been made. Appropriate data-sharing protocols will be evaluated in the future before reaching a decision.
Related trials for Anterior Crossbite
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Recruiting
Comparison Between Protraction Facemask and Upper Braces for Underbite Correction in Growing Children
Anterior Crossbite, Class III Malocclusion in Growing Patients
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.
Özge Güngör, PhD, DDS, Assoc. Prof. study director
Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Aligner and Labiolingual Spring Hawley Appliance in people with Anterior Crossbite, run by Ozge Gungor at 1 site in Turkey (Türkiye).
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 8 inclusion and 6 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 28 Jan 2025. 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 Turkey (Türkiye). 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?
Changes in Cephalometric Measurements Before and After Treatment Assessed Using Dolphin Imaging Software (Version 11.95) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 28 Jan 2025.