Maxillary AnomalyARMENCT06486324
Effects of Asymmetric Rapid Maxillary Expansion on Dentoskeletal Structures in Mixed Dentition
A study testing A locked modified acrylic bonded rapid maxillary expansion appliance (ARME) in people with Maxillary Anomaly and Asymmetric Maxillary Arch (Disorder), run by Celal Irgin.
Trial summary
The aim of this clinical trial was to determine the efficacy of a locked modified bonded acrylic rapid maxillary expansion appliance, also known as an asymmetric rapid maxillary expansion appliance (ARME), in patients with a true unilateral posterior crossbite resulting from transversal maxillary deficiency in the… Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Anomaly, Asymmetric Maxillary Arch (Disorder), Cross Bite
- What is being tested?
- A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Jan 2010
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- mixed dentition
- true unilateral posterior crossbite
- erupted first permanent molars and incisors
- all deciduous canines and molars or no more than one missing deciduous molar
- no history of orthodontic treatment
- no systemic disease
- no pathological periodontal status
- no excessive gagging reflex.
Who cannot join
- poor oral hygiene
- caries
About this study
Official title: Investigation of the Effects of Rapid Maxillary Expansion With Locked Modified Acrylic Bonded Appliance on Dentofacial Structures in Mixed Dentition
The aim of this clinical trial was to determine the efficacy of a locked modified bonded acrylic rapid maxillary expansion appliance, also known as an asymmetric rapid maxillary expansion appliance (ARME), in patients with a true unilateral posterior crossbite resulting from transversal maxillary deficiency in the mixed dentition.
Read the detailed description
A posterior crossbite (PCB) is defined as an abnormal transverse or inverse relationship between the posterior teeth and dentition of the upper and lower jaws. A full buccal segment PCB involves multiple teeth in the posterior dentition and usually represents a transverse size discrepancy between the maxillary and mandibular relationships. This discrepancy is often caused by narrow or underdeveloped transverse dimensions of the maxillary halves. The underlying etiology of PCBs includes congenital, developmental, traumatic, or iatrogenic causes. Since spontaneous correction of this malocclusion is not possible even if the etiological factors are eliminated, it should be treated with maxillary expansion as early as possible.
The PCBs may be seen a unilateral posterior crossbite (UPCB) or bilateral posterior crossbite during all periods of dentition. A UPCB can be described as a functional UPCB or true UPCB. A functional UPCB is usually associated with a lateral shift of the mandible toward the crossbite side during the transition of the mandible. On the other hand, true UPCB is less common than functional UPCB and is caused by the narrowing of one of the maxillary halves. Increasing the maxillary arch transverse dimension is the main goal in the treatment of PCB. Although bilateral maxillary expansion is usually used to symmetrically widen the maxillary arch and eliminate mandibular shift as a standard treatment model in functional PCB, asymmetrical or unilateral maxillary expansion is recommended to expand narrowed sections of the maxillary halves and prevent overexpansion of the non-crossbite side in the treatment of true UPCB. Therefore, several removable or fixed maxillary expansion appliances that are slowly or rapidly activated were modified to produce differential effects on posterior teeth.
This clinical trial was designed to expand the upper jaw asymmetrically, i.e. to prevent the normal side of the bite from expanding while expanding the narrow part of the upper jaw. For this purpose, a locking mechanism was added to a bonded rapid maxillary expansion (RME) appliance to support the lower posterior teeth on the normal side of the bite.The hypothesis tested in the study was whether the true unilateral posterior cross-bite in the mixed dentition period could be corrected with a locked modified bonded rapid maxillary expansion appliance used for asymmetric expansion.
Children aged between 7 and 10 years old with true unilateral posterior crossbite were enrolled in the study. The efficacy of the appliance was compared between the crossbite and non-crossbite sides in the patients included in the study. The crossbite side of the patients was assigned as the treatment group, while the normal bite or noncrossbite side was assigned as the positive control group. Thus, two groups were formed for the study, and the trial was conducted on these groups.In other words, the study was planned as a self-controlled study. A negative control group could not be formed due to ethical reason. The reason for this is that the transversal problem may negatively affect both the anterioposterior and vertical development of the jaws in patients of this age during the developmental period, and therefore it was deemed necessary to correct the cross-bite problem as soon as possible after it was detected.Therefore, the purpose of this study was to evaluate specific dentoskeletal changes induced by treatment with true UPCB in mixed dentition with asymmetric RME.
- Being tested
- A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)
- Keywords
- True unilateral posterior crossbite, Asymmetric maxillary expansion, Mixed dentition
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)Device
Also called Narrow maxillary half intended for expansion or crossbite side
asymmetric maxillary expansion
A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)Device
Also called Normal maxillary half or non-crossbite side
asymmetric maxillary expansion
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Crossbite Side Receives: Device: A locked modified acrylic bonded rapid maxillary expansion appliance (ARME) |
| Positive Control Group | Experimental | Non-cossbite Side Receives: Device: A locked modified acrylic bonded rapid maxillary expansion appliance (ARME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Widths of skeletal structures
The widths of the nasal cavity, maxilla and mandible were measured in millimetres on the frontal radiographs and these widths were also determined separately on both the crossbite and non-crossbite sides.This involved marking anatomical points (lateral piriform rim,jugale, gonial notch and Lo points on both sides of the face and crista galli, a single point) and drawing two reference lines.The horizontal reference line was drawn by connecting the Lo points on both sides.The perpendicular line drawn from the crista galli to the horizontal reference line was the midsagittal line, which divided the face into two separate halves.The distances between the inter lateral piriform points, the inter jugular points and the inter gonial points corresponded to the width of the nasal cavity, the maxillary width and the mandibular width, respectively.The distances between the anatomical points on one half of the face to the midsagittal line indicated the skeletal width on that side.
Measured: Before expansion (T1),through expansion completion,an average 1 month (T2),and through retention completion, an average 3 months (T3)
Skeletal maxillomandibular width ratios
The skeletal maxillomandibular ratio was calculated by dividing the skeletal maxillary width by the skeletal mandibular width and multiplying the result by 100. This percentage was calculated separately for the crossbite and non-crossbite sides and also for the total maxillary and mandibular width.
Measured: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Inclinations of upper and lower first molars
The angle formed by the intersection of the horizontal reference line with the line indicating the axis of a molar tooth defines the angular inclination of the molar tooth. The line indicating the axis of a molar was defined by the line connecting the crest of the buccal tubercle of the tooth and the most external part of the buccal curvature of the crown on the frontal radiograph. The angular inclinations of the upper and lower first molars were measured in degrees on frontal radiographs.
Measured: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Amount of movement of deciduous canines and first molars in the transversal plane on the crossbite and non-crossbite sides.
The perpendicular distances of deciduous canines and permanent first molars on the crossbite and non-crossbite sides to the median plane (MP), which was established as the reference plane on the dental cast. Distance measurements of the teeth were made in millimeter and these measurements represent the amount of movement of the canines and molars in the transverse plane.
Measured: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Intercanine and intermolar distance on dental cast
The distance measurement between the deciduous canines in the transversal plane on the upper and lower dental casts (intercanine distance). The distance measurement between the permanent first molars in the transversal plane on the upper and lower dental casts (intermolar distance). Distance measurements of the teeth were made in millimeter.
Measured: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Secondary outcomes (6)
Position of the maxilla in the sagittal and vertical plane on lateral cephalometric radiography
- SNA angle:The angle formed between the anterior cranial base (SN plane) passing through the Sella (S) and Nasion (N) points and the NA plane passing through the N and A points.It shows the sagittal position of the maxilla in degrees.2)SV⊥A (mm): The perpendicular distance of point A to the Sella Vertical (SV) line. SV was constructed through the Sella, perpendicular to the SN plane. It gives the position of the maxilla in the sagittal direction in millimetres.3)SN-PP angle: The angle formed between the SN plane and the palatal plane (PP) passing through the anterior nasal spine (ANS) and posterior nasal spine (PNS).It shows the vertical position of the maxilla and maxillary rotation in degrees.4)SN⊥ANS (mm): The perpendicular distance of ANS to SN plane. It gives the position of the ANS in the vertical position in millimetres.5)SN⊥PNS (mm): The perpendicular distance of PNS to SN plane. It gives the position of the PNS in the vertical direction in millimetres.
Measured: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Position of the mandibula in the sagittal and vertical plane on lateral cephalometric radiograph
- SNB angle:The angle formed between the anterior cranial base (SN plane) passing through the Sella (S) and Nasion (N) points and the NB plane passing through the Nasion and B points on lateral cephalometric radiography. It shows the sagittal position of the mandible relative to the anterior cranial base in degrees.
- SV⊥B (mm): The perpendicular distance of point B to the Sella Vertical line (SV). SV was constructed through the Sella, perpendicular to the SN plane. It gives the position of the mandible in the sagittal direction in millimetres.
- SN-MP angle: The angle formed between the anterior cranial base (SN plane) passing through the Sella (S) and Nasion (N) points and the mandibular plane (MP) (Gonion-Menton) on lateral cephalometric radiography. It gives information about mandibular vertical position and mandibular rotation in degrees.
Measured: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Maxillomandibular relationship in the sagittal plane on lateral cephalometric radiograph
ANB angle: The angle formed between the NA and NB planes. It shows the positions of the maxilla and mandible relative to each other in the sagittal direction in degrees.
Measured: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Skeletal midface and lower face heights in vertical plane on lateral cephalometric radiograph
- N-ANS (mm): The distance between Nasion (N) and anterior nasal spine (ANS). It shows the skeletal midface height in millimetres.
- ANS-Me (mm): The distance between anterior nasal spine (ANS) and menton (Me). It shows the skeletal lower face height in millimetres.
Measured: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Angulation and position of the upper central incisor on lateral cephalometric radiograph
- U1_SN°: The angle between the long axis of the upper central incisor (U1) and the anterior cranial base (SN plane). It shows the angulation of the upper central incisor relative to the anterior cranial base in degrees.
- SV⊥U1 (mm): The perpendicular distance of incisal edge of the upper central incisor (U1) to Sella Vertical (SV) line. It gives the position of the upper central incisor in the sagittal direction in millimetres.
Measured: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Angulation and position of the lower central incisor on lateral cephalometric radiograph
- L1_MP°: The angle formed between the axis of the most anteriorly located central incisor tooth in the mandible (L1) and the mandibular plane (MP). It gives the angulation of lower central incisor in degrees.
- SV⊥L1 (mm): The perpendicular distance of incisal edge of lower central incisor to Sella Vertical (SV) line. It gives the position of the lower central incisor in the sagittal direction in millimetres.
Measured: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startApr 2007
- Primary completionApr 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maxillary AnomalyStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Split-mouth model. The crossbite side of the patients was assigned as the treatment group, while the normal bite or non-crossbite side of the same patients was assigned as the positive control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celal Irgin
- Sponsor type
- University, hospital or other
- Collaborators
- Selcuk University
- Responsible party
- Sponsor-investigator, Celal Irgin, TC Erciyes University
- Investigators
- Celal Irgın, Asst.Prof., Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486324
- Sponsor's protocol ID
- 08102026
- Acronym
- ARME
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will be made available for sharing as soon as it has been turned into an article.
Publications
Toroglu MS, Uzel E, Kayalioglu M, Uzel I. Asymmetric maxillary expansion (AMEX) appliance for treatment of true unilateral posterior crossbite. Am J Orthod Dentofacial Orthop. 2002 Aug;122(2):164-73. doi: 10.1067/mod.2002.125563.
PubMed 12165770da Silva Filho OG, Boas MC, Capelozza Filho L. Rapid maxillary expansion in the primary and mixed dentitions: a cephalometric evaluation. Am J Orthod Dentofacial Orthop. 1991 Aug;100(2):171-9. doi: 10.1016/s0889-5406(05)81524-0.
PubMed 1867168Sari Z, Uysal T, Usumez S, Basciftci FA. Rapid maxillary expansion. Is it better in the mixed or in the permanent dentition? Angle Orthod. 2003 Dec;73(6):654-61. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
PubMed 14719729
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Rapid Maxillary Expansion With Locked Modified Acrylic Bonded Appliance on Dentofacial Structures in Mixed Dentition
- ClinicalTrials.gov ID
- NCT06486324
- Acronym / sponsor ID
- ARME / 08102026
- Keywords
- True unilateral posterior crossbite, Asymmetric maxillary expansion, Mixed dentition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Celal IrginUniversity, hospital or other
- Collaborators
- Selcuk University
- Study start
- Apr 2007 (actual)
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Jul 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.
The aim of this clinical trial was to determine the efficacy of a locked modified bonded acrylic rapid maxillary expansion appliance, also known as an asymmetric rapid maxillary expansion appliance (ARME), in patients with a true unilateral posterior crossbite resulting from transversal maxillary deficiency in the mixed dentition.
Detailed description
A posterior crossbite (PCB) is defined as an abnormal transverse or inverse relationship between the posterior teeth and dentition of the upper and lower jaws. A full buccal segment PCB involves multiple teeth in the posterior dentition and usually represents a transverse size discrepancy between the maxillary and mandibular relationships. This discrepancy is often caused by narrow or underdeveloped transverse dimensions of the maxillary halves. The underlying etiology of PCBs includes congenital, developmental, traumatic, or iatrogenic causes. Since spontaneous correction of this malocclusion is not possible even if the etiological factors are eliminated, it should be treated with maxillary expansion as early as possible.
The PCBs may be seen a unilateral posterior crossbite (UPCB) or bilateral posterior crossbite during all periods of dentition. A UPCB can be described as a functional UPCB or true UPCB. A functional UPCB is usually associated with a lateral shift of the mandible toward the crossbite side during the transition of the mandible. On the other hand, true UPCB is less common than functional UPCB and is caused by the narrowing of one of the maxillary halves. Increasing the maxillary arch transverse dimension is the main goal in the treatment of PCB. Although bilateral maxillary expansion is usually used to symmetrically widen the maxillary arch and eliminate mandibular shift as a standard treatment model in functional PCB, asymmetrical or unilateral maxillary expansion is recommended to expand narrowed sections of the maxillary halves and prevent overexpansion of the non-crossbite side in the treatment of true UPCB. Therefore, several removable or fixed maxillary expansion appliances that are slowly or rapidly activated were modified to produce differential effects on posterior teeth.
This clinical trial was designed to expand the upper jaw asymmetrically, i.e. to prevent the normal side of the bite from expanding while expanding the narrow part of the upper jaw. For this purpose, a locking mechanism was added to a bonded rapid maxillary expansion (RME) appliance to support the lower posterior teeth on the normal side of the bite.The hypothesis tested in the study was whether the true unilateral posterior cross-bite in the mixed dentition period could be corrected with a locked modified bonded rapid maxillary expansion appliance used for asymmetric expansion.
Children aged between 7 and 10 years old with true unilateral posterior crossbite were enrolled in the study. The efficacy of the appliance was compared between the crossbite and non-crossbite sides in the patients included in the study. The crossbite side of the patients was assigned as the treatment group, while the normal bite or noncrossbite side was assigned as the positive control group. Thus, two groups were formed for the study, and the trial was conducted on these groups.In other words, the study was planned as a self-controlled study. A negative control group could not be formed due to ethical reason. The reason for this is that the transversal problem may negatively affect both the anterioposterior and vertical development of the jaws in patients of this age during the developmental period, and therefore it was deemed necessary to correct the cross-bite problem as soon as possible after it was detected.Therefore, the purpose of this study was to evaluate specific dentoskeletal changes induced by treatment with true UPCB in mixed dentition with asymmetric RME.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth model. The crossbite side of the patients was assigned as the treatment group, while the normal bite or non-crossbite side of the same patients was assigned as the positive control group.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)Crossbite Side |
| Positive Control Group | Experimental | Device: A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)Non-cossbite Side |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- mixed dentition
- true unilateral posterior crossbite
- erupted first permanent molars and incisors
- all deciduous canines and molars or no more than one missing deciduous molar
- no history of orthodontic treatment
Key exclusion criteria (2 listed)
- poor oral hygiene
- caries
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 |
|---|---|---|
| A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)Also: Narrow maxillary half intended for expansion or crossbite sideasymmetric maxillary expansion | Device | Treatment Group |
| A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)Also: Normal maxillary half or non-crossbite sideasymmetric maxillary expansion | Device | Positive Control Group |
Primary outcome
Widths of skeletal structures
Time frame: Before expansion (T1),through expansion completion,an average 1 month (T2),and through retention completion, an average 3 months (T3)
The widths of the nasal cavity, maxilla and mandible were measured in millimetres on the frontal radiographs and these widths were also determined separately on both the crossbite and non-crossbite sides.This involved marking anatomical points (lateral piriform rim,jugale, gonial notch and Lo points on both sides of the face and crista galli, a single point) and drawing two reference lines.The horizontal reference line was drawn by connecting the Lo points on both sides.The perpendicular line drawn from the crista galli to the horizontal reference line was the midsagittal line, which divided the face into two separate halves.The distances between the inter lateral piriform points, the inter jugular points and the inter gonial points corresponded to the width of the nasal cavity, the maxillary width and the mandibular width, respectively.The distances between the anatomical points on one half of the face to the midsagittal line indicated the skeletal width on that side.
Skeletal maxillomandibular width ratios
Time frame: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
The skeletal maxillomandibular ratio was calculated by dividing the skeletal maxillary width by the skeletal mandibular width and multiplying the result by 100. This percentage was calculated separately for the crossbite and non-crossbite sides and also for the total maxillary and mandibular width.
Inclinations of upper and lower first molars
Time frame: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
The angle formed by the intersection of the horizontal reference line with the line indicating the axis of a molar tooth defines the angular inclination of the molar tooth. The line indicating the axis of a molar was defined by the line connecting the crest of the buccal tubercle of the tooth and the most external part of the buccal curvature of the crown on the frontal radiograph. The angular inclinations of the upper and lower first molars were measured in degrees on frontal radiographs.
Amount of movement of deciduous canines and first molars in the transversal plane on the crossbite and non-crossbite sides.
Time frame: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
The perpendicular distances of deciduous canines and permanent first molars on the crossbite and non-crossbite sides to the median plane (MP), which was established as the reference plane on the dental cast. Distance measurements of the teeth were made in millimeter and these measurements represent the amount of movement of the canines and molars in the transverse plane.
Intercanine and intermolar distance on dental cast
Time frame: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
The distance measurement between the deciduous canines in the transversal plane on the upper and lower dental casts (intercanine distance). The distance measurement between the permanent first molars in the transversal plane on the upper and lower dental casts (intermolar distance). Distance measurements of the teeth were made in millimeter.
6 secondary outcomes
Position of the maxilla in the sagittal and vertical plane on lateral cephalometric radiography
Time frame: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Position of the mandibula in the sagittal and vertical plane on lateral cephalometric radiograph
Time frame: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Maxillomandibular relationship in the sagittal plane on lateral cephalometric radiograph
Time frame: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Skeletal midface and lower face heights in vertical plane on lateral cephalometric radiograph
Time frame: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Angulation and position of the upper central incisor on lateral cephalometric radiograph
Time frame: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
Angulation and position of the lower central incisor on lateral cephalometric radiograph
Time frame: Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)
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 3 Jul 2024.
- Results publication: PubMed 12165770Toroglu MS, Uzel E, Kayalioglu M, Uzel I. Asymmetric maxillary expansion (AMEX) appliance for treatment of true unilateral posterior crossbite. Am J Orthod Dentofacial Orthop. 2002 Aug;122(2):164-73. doi: 10.1067/mod.2002.125563.
- Results publication: PubMed 1867168da Silva Filho OG, Boas MC, Capelozza Filho L. Rapid maxillary expansion in the primary and mixed dentitions: a cephalometric evaluation. Am J Orthod Dentofacial Orthop. 1991 Aug;100(2):171-9. doi: 10.1016/s0889-5406(05)81524-0.
- Results publication: PubMed 14719729Sari Z, Uysal T, Usumez S, Basciftci FA. Rapid maxillary expansion. Is it better in the mixed or in the permanent dentition? Angle Orthod. 2003 Dec;73(6):654-61. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
- Individual participant dataSharing planned: No. The study will be made available for sharing as soon as it has been turned into an article.
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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.
Celal Irgın, Asst.Prof. principal investigator
Selcuk University
Questions about this trial
What is this clinical trial studying?
A study testing A locked modified acrylic bonded rapid maxillary expansion appliance (ARME) in people with Maxillary Anomaly and Asymmetric Maxillary Arch (Disorder), run by Celal Irgin.
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 2 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Widths of skeletal structures (time frame: Before expansion (T1),through expansion completion,an average 1 month (T2),and through retention completion, an average 3 months (T3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06486324, which also lists 3 linked publications.
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 3 Jul 2024.