Anterior CrossbiteNCT04863404
Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency
A study testing Face mask with hybrid-hyrax and Face mask with conventional bonded RME in people with Anterior Crossbite and Class III Malocclusion, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective randomized controlled clinical study is to compare the effects of bone-anchored and tooth borne maxillary protraction on dentofacial structures in skeletal Class III patients. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Crossbite, Class III Malocclusion, Maxillary Deficiency
- What is being tested?
- Face mask with hybrid-hyrax and Face mask with conventional bonded RME
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 20 Oct 2021
- 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 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Late mixed or early permanent dentition
- C3 or C4 period according to the cervical vertebral maturation method
- Presence of skeletal class III malocclusion (ANB <0 °).
- Retrusive nasomaxillary complex (Nperp-A <1 mm).
- Presence of dental class III malocclusion
- Normal or horizontal growth pattern (SNGoGn <40 °).
Show all 14Show fewer
- Negative overjet (overjet <0)
- Good cooperation
- Absence of any systemic disease
- Periodontal health
- No previous orthodontic treatment
- No craniofacial deformity
- No neuromuscular deformity
- The absence of a congenital anomaly
Who cannot join
- Poor cooperation
- Early mixed dentition
- Individuals who have passed the C4 period
- Craniofacial deformity
- Congenital anomaly
- A history of facial trauma Syndromes such as cleft lip and palate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Katip Celebi University,Faculty of Dentistry, Department of Orthodontics
Izmir, Çiğli, 35640
Burcin Akan, Phd
About this study
The aim of this prospective randomized controlled clinical study is to compare the effects of bone-anchored and tooth borne maxillary protraction on dentofacial structures in skeletal Class III patients.
Read the detailed description
Today, the treatment of class III malocclusion is becoming more important due to the increased awareness of people about their appearance and the impact of appearance on the psychosocial state.
Various studies have shown that 40% of class III malocclusions are clinically caused by maxillary deficiency, 42% by mandibular excess, and 18% by a combination of maxillary deficiency and mandibular excess.
The face mask is the most effective treatment modality for class III malocclusions caused by a maxillary deficiency. The rationale for using a face mask is to apply heavy forces to the midface to advance the maxilla forward. These forces cause disarticulation by initiating resorption and apposition in the sutural articulations. However, undesirable dental effects arise from the use of tooth-borne rapid maxillary expansion (RME) during these treatments. These include loss of anchorage and incisor proclination during the mesialization of the maxillary dentition, extrusion of the upper molars and posterior mandibular rotation, and insufficient anterior displacement of the maxilla (1-3 mm).
Studies have shown that increasing the skeletal effects can reduce post-treatment relapse, one of the most important problems in orthodontics.
To increase the amount of maxillary skeletal advancement and to minimize the side effects of tooth-borne maxillary expansion and protraction, a new bone-anchored hybrid hyrax appliance has been proposed. Hybrid hyrax treatment has the following advantages over tooth-borne mechanics:
- Since the force is applied close to the center of resistance of the maxilla, counterclockwise rotation of the maxilla and related posterior mandibular rotation are not observed.
- Transversal forces are applied to premolars or deciduous molars and mini implants without the risk of periodontal damage, fenestration, and dehiscence that may occur with tooth-borne appliances are avoided.
- Mesial migration of the dentition, proclination of the upper incisors, and occupation of the necessary place for the canines to erupt are avoided.
- Treatment is minimally invasive.
- Upper and lower arches remain completely accessible for orthodontic interventions.
- Only skeletal maxillary advancement is achieved. In our study, additionally, the Alternate Rapid Maxillary Expansion and Constriction (AltRamec) protocol, which increases the skeletal effects during maxillary protraction by providing more effective disarticulation of circummaxillary sutures than conventional rapid maxillary expansion was used.
- Being tested
- Face mask with hybrid-hyrax, Face mask with conventional bonded RME
- Keywords
- maxillary protraction, tooth-borne vs bone-anchored, face mask, AltRamec, rme, Temporary anchorage devices (TADs) in the anterior palate, hybrid hyrax
- Medical subject headings
- Malocclusion, Angle Class III, Retrognathia, Tietz syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face mask with hybrid-hyraxOther
Face mask with hybrid-hyrax
Face mask with conventional bonded RMEOther
Face mask with conventional bonded RME
| Study group | Role | What they receive |
|---|---|---|
| Bone-anchored maxillary protraction group | Experimental | Face mask with hybrid-hyrax Receives: Other: Face mask with hybrid-hyrax |
| Tooth-borne maxillary protraction group | Experimental | Face mask with conventional bonded RME Receives: Other: Face mask with conventional bonded RME |
| Control group | No intervention | Control group consisting of 14 non-treated Class III malocclusion subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-treatment (T0) cephalometric analysis measures
A cephalometric analysis of skeletal maxillary (SNA) and mandibular (SNB) positions
Measured: 0 month
Pre-treatment (T0) soft tissues measurements
Maxillary and mandibular (Soft tissue convexity angle) soft tissue analysis using 3D stereophotogrammetry
Measured: 0 month
Secondary outcomes (2)
Post-treatment (T1) cephalometric analysis measurements
Evaluation of pos-treatment cephalometric changes of skeletal maxillary (SNA) and mandibular (SNB) positions
Measured: An average of 6 month
Post-treatment (T1) soft tissues measurements
Evaluation of maxillary and mandibular soft tissue changes (Soft tissue convexity angle) using 3D stereophotogrammetry
Measured: An average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start15 Jun 2020
- Primary completion20 May 2021 (estimated)
- Study completion20 Oct 2021 (estimated)
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
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Akan, Izmir Katip Celebi University
- Investigators
- Burcin AKAN, Phd, Study director, Academician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863404
- Sponsor's protocol ID
- 2021-TDU-DİŞF-0003
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency
- ClinicalTrials.gov ID
- NCT04863404
- Acronym / sponsor ID
- 2021-TDU-DİŞF-0003
- Keywords
- maxillary protraction, tooth-borne vs bone-anchored, face mask, AltRamec, rme, Temporary anchorage devices (TADs) in the anterior palate, hybrid hyrax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 20 May 2021 (estimated)
- Study completion
- 20 Oct 2021 (estimated)
- First posted
- 28 Apr 2021 (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.
The aim of this prospective randomized controlled clinical study is to compare the effects of bone-anchored and tooth borne maxillary protraction on dentofacial structures in skeletal Class III patients.
Detailed description
Today, the treatment of class III malocclusion is becoming more important due to the increased awareness of people about their appearance and the impact of appearance on the psychosocial state.
Various studies have shown that 40% of class III malocclusions are clinically caused by maxillary deficiency, 42% by mandibular excess, and 18% by a combination of maxillary deficiency and mandibular excess.
The face mask is the most effective treatment modality for class III malocclusions caused by a maxillary deficiency. The rationale for using a face mask is to apply heavy forces to the midface to advance the maxilla forward. These forces cause disarticulation by initiating resorption and apposition in the sutural articulations. However, undesirable dental effects arise from the use of tooth-borne rapid maxillary expansion (RME) during these treatments. These include loss of anchorage and incisor proclination during the mesialization of the maxillary dentition, extrusion of the upper molars and posterior mandibular rotation, and insufficient anterior displacement of the maxilla (1-3 mm).
Studies have shown that increasing the skeletal effects can reduce post-treatment relapse, one of the most important problems in orthodontics.
To increase the amount of maxillary skeletal advancement and to minimize the side effects of tooth-borne maxillary expansion and protraction, a new bone-anchored hybrid hyrax appliance has been proposed. Hybrid hyrax treatment has the following advantages over tooth-borne mechanics:
- Since the force is applied close to the center of resistance of the maxilla, counterclockwise rotation of the maxilla and related posterior mandibular rotation are not observed.
- Transversal forces are applied to premolars or deciduous molars and mini implants without the risk of periodontal damage, fenestration, and dehiscence that may occur with tooth-borne appliances are avoided.
- Mesial migration of the dentition, proclination of the upper incisors, and occupation of the necessary place for the canines to erupt are avoided.
- Treatment is minimally invasive.
- Upper and lower arches remain completely accessible for orthodontic interventions.
- Only skeletal maxillary advancement is achieved. In our study, additionally, the Alternate Rapid Maxillary Expansion and Constriction (AltRamec) protocol, which increases the skeletal effects during maxillary protraction by providing more effective disarticulation of circummaxillary sutures than conventional rapid maxillary expansion was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bone-anchored maxillary protraction group | Experimental | Other: Face mask with hybrid-hyraxFace mask with hybrid-hyrax |
| Tooth-borne maxillary protraction group | Experimental | Other: Face mask with conventional bonded RMEFace mask with conventional bonded RME |
| Control group | No intervention | –Control group consisting of 14 non-treated Class III malocclusion subjects |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Late mixed or early permanent dentition
- C3 or C4 period according to the cervical vertebral maturation method
- Presence of skeletal class III malocclusion (ANB <0 °).
- Retrusive nasomaxillary complex (Nperp-A <1 mm).
- Presence of dental class III malocclusion
Key exclusion criteria (6 listed)
- Poor cooperation
- Early mixed dentition
- Individuals who have passed the C4 period
- Craniofacial deformity
- Congenital anomaly
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 |
|---|---|---|
| Face mask with hybrid-hyraxFace mask with hybrid-hyrax | Other | Bone-anchored maxillary protraction group |
| Face mask with conventional bonded RMEFace mask with conventional bonded RME | Other | Tooth-borne maxillary protraction group |
Primary outcome
Pre-treatment (T0) cephalometric analysis measures
Time frame: 0 month
A cephalometric analysis of skeletal maxillary (SNA) and mandibular (SNB) positions
Pre-treatment (T0) soft tissues measurements
Time frame: 0 month
Maxillary and mandibular (Soft tissue convexity angle) soft tissue analysis using 3D stereophotogrammetry
2 secondary outcomes
Post-treatment (T1) cephalometric analysis measurements
Time frame: An average of 6 month
Post-treatment (T1) soft tissues measurements
Time frame: An average of 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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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.
Burcin AKAN, Phd study director
Academician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face mask with hybrid-hyrax and Face mask with conventional bonded RME in people with Anterior Crossbite and Class III Malocclusion, run by Izmir Katip Celebi University 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 14 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Burcin AKAN, Phd (+90 5367103040, Burcin.yksel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-treatment (T0) cephalometric analysis measures (time frame: 0 month). 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 Apr 2021.