Malocclusion, Angle Class IINCT03159962
Mandibular Response After Maxillary Orthopedic Expansion in Class II Growing Subjects
A study testing Bonded RME (Rapid Maxillary Expander) appliance and Banded RME (Rapid Maxillary Expander) appliance in people with Malocclusion, Angle Class II and Malocclusion, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
the effectiveness of RME (Rapid Maxillary Expander) on the sagittal dental or skeletal parameters is still controversial because very little has been written regarding the behavior of antero-posterior mandibular changes in Class II growing subjects who underwent RME as the phase 1 treatment intervention. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Malocclusion, Angle Class II, Malocclusion
- What is being tested?
- Bonded RME (Rapid Maxillary Expander) appliance and Banded RME (Rapid Maxillary Expander) appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Nov 2016
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- early mixed dentition with first molars fully erupted,
- Class II malocclusion (full-cusp or end-to-end molar relationships),
- negative posterior transverse interarch discrepancy ≥ 4 mm,
- Overjet ≥ 5 mm,
- and prepubertal stage of development (Cervical Stage 1 - Cervical Stage 2 in cervical vertebral maturation)
Who cannot join
- previous orthodontic treatment,
- extracted or congenitally missing teeth,
- craniofacial syndromes or clefts,
- use of additional orthodontic devices during the observation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mandibular Response After Rapid Maxillary Expansion in Class II Growing Patients: a Pilot Randomized Controlled Trial
the effectiveness of RME (Rapid Maxillary Expander) on the sagittal dental or skeletal parameters is still controversial because very little has been written regarding the behavior of antero-posterior mandibular changes in Class II growing subjects who underwent RME as the phase 1 treatment intervention. The reported significant occlusal improvement could be attributed to other reasons, ie, skeletal growth or the use of additional appliances during transition from mixed to permanent dentition. Moreover, the majority of the studies show some limits: they are not randomized, they are not prospective, and they have no control group or they use patients from growth studies as a source for the control group. The primary objective of the present investigation was to conduct a pilot randomized controlled trial (RCT) evaluating the changes in the antero-posterior mandibular position induced by bonded or banded RMEs compared with an untreated Class II control group
Read the detailed description
Class II malocclusions are commonly observed in orthodontic patients. During treatment planning among the several dento-skeletal pattern combinations of Class II malocclusion, it is important to consider the maxillary transverse deficiency, which is often overlooked.
it has been showed showed an underlying posterior interarch transverse discrepancy of 3 to 5 mm in subjects in early mixed dentition with Class II malocclusions without posterior crossbites in centric occlusion. When these Class II patients are asked to posture their lower jaw forward in a Class I molar relationship, this transverse discrepancy (ie, maxillary constriction) can be observed clinically. It was postulated that in these subjects the mandible is kept in a distal position relative to centric relation because the constricted maxilla is holding it back. The presence of a primitive transverse discrepancy between the dental arches induces a backward position of the mandible, as the occlusal goal is to obtain the highest number of functional contacts.
As reported by several authors, widening the maxilla with rapid maxillary expansion often leads to spontaneous forward posturing of the mandible during the retention period. The orthopedic expansion removes occlusal interferences, allowing the mandible to posture forward, thus improving the sagittal relationships. The mandibular arch acts as a ''foot'' that moves forward after the ''shoe'' is widened.
However, the effectiveness of RME on the sagittal dental or skeletal parameters is still controversial because very little has been written regarding the behavior of antero-posterior mandibular changes in Class II growing subjects who underwent RME as the phase 1 treatment intervention. The reported significant occlusal improvement could be attributed to other reasons, ie, skeletal growth or the use of additional appliances during transition from mixed to permanent dentition. Moreover, the majority of the studies show some limits: they are not randomized, they are not prospective, and they have no control group or they use patients from growth studies as a source for the control group.
Considering that it was not possible to estimate from previous studies the standard deviation to be used for sample size calculation of the main trial with special regards to type of intervention and observation intervals, the primary objective of the present investigation was to conduct a pilot randomized controlled trial (RCT) evaluating the changes in the antero-posterior mandibular position induced by bonded or banded RMEs compared with an untreated Class II control group.
To evaluate the sagittal mandibular response induced by RME therapy in mixed dentition patients with Class II malocclusion, comparing the effects of bonded RME and banded RME with a matched untreated Class II control group
This is a single center, prospective 3-arm parallel group randomized clinical trial with a 1:1:1allocation ratio. 30 (thirty) of subjects are planned. Each subject in the treated groups will be treated with a Rapid Maxillary Expander (RME), bonded or banded respectively. Subjects will be assigned to the groups in random order. Evaluations will be taken at baseline and at the end of the retention period/follow up (for a total of 12 months). Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Allocation of patients to the three groups in a 1:1:1 ratio was determined by a computer-generated randomization list using Rv.0.1 software and by a block size of 4. Then, the allocation information (randomization results) was concealed in opaque and sealed envelopes by the statistician.
The study was blinded in regard of the statistical analysis. Data were recorded and blinded for the statistician: blinding was obtained by eliminating from the elaboration file every reference to patient group assignment
To determine the reliability of the method 15 radiographs chosen at random were traced and digitized by the same investigator on 2 separate occasions at least one month apart. A paired t-test was used to compare the two measurements (systematic error). The magnitude of the random error was calculated by using the method of moment's estimator (MME). Exploratory statistics revealed that not all cephalometric variables were normally distributed (Kolmogorov-Smirnov test) with equality of variances (Levene's test).Kruskal-Wallis test or ANOVA with Tukey's post-hoc tests were used to compare the T2-T1 changes in the three groups. All changes were considered significant at P<0.05. All statistical computations were performed with Statistical Package for the Social Sciences software (Version 12, Chicago, IL)..
10 randomized subjects will be included in the treated group 1, 10 randomized patients will be included in the treated group 2 and 10 randomized patients will be used as untreated control group.
The baseline age was 8.1 ± 0.6 years (range 6.6-9.1 years).
Sample size for this pilot trial was calculated according to the method proposed by Whitehead et al. For a standardized effect size of 1 (a clinically relevant change of 2.0 mm with a combined Standard Deviation of 2.0 mm derived from Guest et al.) for the 8 primary outcome variable Pogonion to Nasion perpendicular, a sample size of 10 subjects per group was required for a Type I error rate of 5% and a power of 80%.
- Conditions
- Malocclusion, Angle Class II, Malocclusion
- Being tested
- Bonded RME (Rapid Maxillary Expander) appliance, Banded RME (Rapid Maxillary Expander) appliance
- Keywords
- Rapid maxillary expansion, Mandibular response, Class II malocclusion, Growing subjects
- Medical subject headings
- Malocclusion, Angle Class II, Malocclusion, Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bonded RME (Rapid Maxillary Expander) applianceDevice
The expansion screw was activated 1 quarter of a turn per day (0.25 mm per turn) until the palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.
The expander was kept in place as a passive retainer for 8 months. After expander removal, patients were followed without performing any additional treatment for 4 months.
Banded RME (Rapid Maxillary Expander) applianceDevice
The expansion screw was activated 1 quarter of a turn per day (0.25 mm per turn) until the palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.
The expander was kept in place as a passive retainer for 8 months. After expander removal, patients were followed without performing any additional treatment for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Treated Group 1 | Active comparator | Patient treated with bonded RME (Rapid Maxillary Expander) with a 13-mm screw. The acrylic splints of the bonded expander extended from the first deciduous molars through the first permanent molars. Receives: Device: Bonded RME (Rapid Maxillary Expander) appliance |
| Treated Group 2 | Active comparator | Patients treated with banded RME (Rapid Maxillary Expander) in the form of a butterfly palatal expander with a 13-mm screw cemented through bands on the second deciduous upper molars. Receives: Device: Banded RME (Rapid Maxillary Expander) appliance |
| Untreated Control Group | No intervention | Matched untreated Class II control group prospectively evaluated after one year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular displacement after RME appliance therapy (linear measurement in millimeters) when compared with a matched untreated control group
The primary outcome was the change in the position of point Pogonion to the Nasion perpendicular (Pg to N perp). The objective is to evaluate the changes in the sagittal mandibular position induced by bonded or banded RMEs compared with an untreated control group.
For each treated patient, standard lateral cephalograms were obtained before treatment and after 1 year to evaluate the dento-skeletal changes. The Control Group was followed up without treatment for 1 year and had lateral cephalograms before and after a one-year interval.
Cephalograms were scanned using a professional table scanner (Epson Perfection V700 Photo, CA, USA), with resolution set to 150 dots per inch (dpi) gray scale and were digitized by 1 investigator., followed by a customized digitization regimen and analysis (Viewbox 3.1; dHAL Software, Kifissia, Greece). All cephalograms were at a magnification of 0%. The examiner was blinded to the origin of the films and the group to which each subject belonged
Measured: 12 months
Secondary outcomes (2)
Occlusal improvement of Class II molar relationship after RME appliance therapy (linear measurement in millimeters) when compared with a matched untreated control group
The secondary outcome is to evaluate if maxillary expansion corrects or improves a Class II molar relationship (the mesiobuccal cusp of the maxillary permanent 1st molar must occlude in the embrasure between the mandibular 2nd premolar and the mandibular permanent 1st molar) when compared with an untreated control group. For each treated patient, lateral cephalograms were obtained before treatment and after 1 year to evaluate the dento-skeletal changes. Untreated patients had lateral cephalograms before and after a 1 year interval. Cephalograms were scanned using a professional table scanner (Epson Perfection V700 Photo, CA, USA), with resolution set to 150 dots per inch (dpi) gray scale and were digitized by 1 investigator., followed by a customized digitization regimen and analysis (Viewbox 3.1; dHAL Software, Kifissia, Greece). All cephalograms were at a magnification of 0%. The examiner was blinded to the origin of the films and the group to which each subject belonged
Measured: 12 months
Treatment effects on vertical dimension (SN-Go Me; angular measurement) and on Gonial Angle (Ar-Go-Me, angular measurement) and vertical growth pattern after RME appliance therapy when compared with a matched untreated control group
The objective is to verify if the treatment determined a reduction of the facial divergency (SN-Go Me°) and of the gonial angle (Ar-Go-Me°) when both subjects, treated respectively with banded RME and bonded RME, are compared with untreated subjects.
For each treated patient, standard lateral cephalograms were obtained before treatment and after 1 year to evaluate the dento-skeletal changes. The Control Group was followed up without treatment for 1 year and had lateral cephalograms before and after a one-year interval.
Cephalograms were scanned using a professional table scanner (Epson Perfection V700 Photo, CA, USA), with resolution set to 150 dots per inch (dpi) gray scale and were digitized by 1 investigator., followed by a customized digitization regimen and analysis (Viewbox 3.1; dHAL Software, Kifissia, Greece). All cephalograms were at a magnification of 0%. The examiner was blinded to the origin of the films and the group to which each subject belonged
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study startJan 2015
- Primary completionNov 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IIStudies 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
- Model description
- prospective 3-arm parallel group randomized clinical trial with a 1:1:1 allocation ratio
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Lione, University of Rome Tor Vergata
- Investigators
- Roberta Lione, Dentistry, Principal investigator, Research Fellow, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata," Rome, Italy, and research Fellow, Department of Dentistry, University Nostra Signora del Buon Consiglio, Tirana, Albania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159962
- Sponsor's protocol ID
- 130/14
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no individual participant data are to be shared
Publications
McNamara JA Jr, Sigler LM, Franchi L, Guest SS, Baccetti T. Changes in occlusal relationships in mixed dentition patients treated with rapid maxillary expansion. A prospective clinical study. Angle Orthod. 2010 Mar;80(2):230-8. doi: 10.2319/040309-192.1.
PubMed 19905846Baratieri C, Alves M Jr, Bolognese AM, Nojima MC, Nojima LI. Changes in skeletal and dental relationship in Class II Division I malocclusion after rapid maxillary expansion: a prospective study. Dental Press J Orthod. 2014 May-Jun;19(3):75-81. doi: 10.1590/2176-9451.19.3.075-081.oar.
PubMed 25162569Baccetti T, Franchi L, McNamara JA Jr, Tollaro I. Early dentofacial features of Class II malocclusion: a longitudinal study from the deciduous through the mixed dentition. Am J Orthod Dentofacial Orthop. 1997 May;111(5):502-9. doi: 10.1016/s0889-5406(97)70287-7.
PubMed 9155809Tollaro I, Baccetti T, Franchi L, Tanasescu CD. Role of posterior transverse interarch discrepancy in Class II, Division 1 malocclusion during the mixed dentition phase. Am J Orthod Dentofacial Orthop. 1996 Oct;110(4):417-22. doi: 10.1016/s0889-5406(96)70045-8.
PubMed 8876494McNamara JA. Maxillary transverse deficiency. Am J Orthod Dentofacial Orthop. 2000 May;117(5):567-70. doi: 10.1016/s0889-5406(00)70202-2. No abstract available.
PubMed 10799117Guest SS, McNamara JA Jr, Baccetti T, Franchi L. Improving Class II malocclusion as a side-effect of rapid maxillary expansion: a prospective clinical study. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):582-91. doi: 10.1016/j.ajodo.2008.12.026.
PubMed 21055598Wendling LK, McNamara JA Jr, Franchi L, Baccetti T. A prospective study of the short-term treatment effects of the acrylic-splint rapid maxillary expander combined with the lower Schwarz appliance. Angle Orthod. 2005 Jan;75(1):7-14. doi: 10.1043/0003-3219(2005)0752.0.CO;2.
PubMed 15747809Feres MF, Raza H, Alhadlaq A, El-Bialy T. Rapid maxillary expansion effects in Class II malocclusion: a systematic review. Angle Orthod. 2015 Nov;85(6):1070-9. doi: 10.2319/102514-768.1.
PubMed 26516713Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476Springate SD. The effect of sample size and bias on the reliability of estimates of error: a comparative study of Dahlberg's formula. Eur J Orthod. 2012 Apr;34(2):158-63. doi: 10.1093/ejo/cjr010. Epub 2011 Mar 29.
PubMed 21447784Baratieri C, Alves M Jr, Sant'anna EF, Nojima Mda C, Nojima LI. 3D mandibular positioning after rapid maxillary expansion in Class II malocclusion. Braz Dent J. 2011;22(5):428-34. doi: 10.1590/s0103-64402011000500014.
PubMed 22011901Volk T, Sadowsky C, Begole EA, Boice P. Rapid palatal expansion for spontaneous Class II correction. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):310-5. doi: 10.1016/j.ajodo.2008.05.017.
PubMed 20197166Schulz SO, McNamara JA Jr, Baccetti T, Franchi L. Treatment effects of bonded RME and vertical-pull chincup followed by fixed appliance in patients with increased vertical dimension. Am J Orthod Dentofacial Orthop. 2005 Sep;128(3):326-36. doi: 10.1016/j.ajodo.2004.03.039.
PubMed 16168329Asanza S, Cisneros GJ, Nieberg LG. Comparison of Hyrax and bonded expansion appliances. Angle Orthod. 1997;67(1):15-22. doi: 10.1043/0003-3219(1997)0672.3.CO;2.
PubMed 9046395Lione R, Brunelli V, Franchi L, Pavoni C, Quiroga Souki B, Cozza P. Mandibular response after rapid maxillary expansion in class II growing patients: a pilot randomized controlled trial. Prog Orthod. 2017 Nov 6;18(1):36. doi: 10.1186/s40510-017-0189-6.
PubMed 29105023
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Response After Rapid Maxillary Expansion in Class II Growing Patients: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03159962
- Acronym / sponsor ID
- 130/14
- Conditions
- Malocclusion, Angle Class II, Malocclusion
- Keywords
- Rapid maxillary expansion, Mandibular response, Class II malocclusion, Growing subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 May 2017 (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 effectiveness of RME (Rapid Maxillary Expander) on the sagittal dental or skeletal parameters is still controversial because very little has been written regarding the behavior of antero-posterior mandibular changes in Class II growing subjects who underwent RME as the phase 1 treatment intervention. The reported significant occlusal improvement could be attributed to other reasons, ie, skeletal growth or the use of additional appliances during transition from mixed to permanent dentition. Moreover, the majority of the studies show some limits: they are not randomized, they are not prospective, and they have no control group or they use patients from growth studies as a source for the control group. The primary objective of the present investigation was to conduct a pilot randomized controlled trial (RCT) evaluating the changes in the antero-posterior mandibular position induced by bonded or banded RMEs compared with an untreated Class II control group
Detailed description
Class II malocclusions are commonly observed in orthodontic patients. During treatment planning among the several dento-skeletal pattern combinations of Class II malocclusion, it is important to consider the maxillary transverse deficiency, which is often overlooked.
it has been showed showed an underlying posterior interarch transverse discrepancy of 3 to 5 mm in subjects in early mixed dentition with Class II malocclusions without posterior crossbites in centric occlusion. When these Class II patients are asked to posture their lower jaw forward in a Class I molar relationship, this transverse discrepancy (ie, maxillary constriction) can be observed clinically. It was postulated that in these subjects the mandible is kept in a distal position relative to centric relation because the constricted maxilla is holding it back. The presence of a primitive transverse discrepancy between the dental arches induces a backward position of the mandible, as the occlusal goal is to obtain the highest number of functional contacts.
As reported by several authors, widening the maxilla with rapid maxillary expansion often leads to spontaneous forward posturing of the mandible during the retention period. The orthopedic expansion removes occlusal interferences, allowing the mandible to posture forward, thus improving the sagittal relationships. The mandibular arch acts as a ''foot'' that moves forward after the ''shoe'' is widened.
However, the effectiveness of RME on the sagittal dental or skeletal parameters is still controversial because very little has been written regarding the behavior of antero-posterior mandibular changes in Class II growing subjects who underwent RME as the phase 1 treatment intervention. The reported significant occlusal improvement could be attributed to other reasons, ie, skeletal growth or the use of additional appliances during transition from mixed to permanent dentition. Moreover, the majority of the studies show some limits: they are not randomized, they are not prospective, and they have no control group or they use patients from growth studies as a source for the control group.
Considering that it was not possible to estimate from previous studies the standard deviation to be used for sample size calculation of the main trial with special regards to type of intervention and observation intervals, the primary objective of the present investigation was to conduct a pilot randomized controlled trial (RCT) evaluating the changes in the antero-posterior mandibular position induced by bonded or banded RMEs compared with an untreated Class II control group.
To evaluate the sagittal mandibular response induced by RME therapy in mixed dentition patients with Class II malocclusion, comparing the effects of bonded RME and banded RME with a matched untreated Class II control group
This is a single center, prospective 3-arm parallel group randomized clinical trial with a 1:1:1allocation ratio. 30 (thirty) of subjects are planned. Each subject in the treated groups will be treated with a Rapid Maxillary Expander (RME), bonded or banded respectively. Subjects will be assigned to the groups in random order. Evaluations will be taken at baseline and at the end of the retention period/follow up (for a total of 12 months). Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Allocation of patients to the three groups in a 1:1:1 ratio was determined by a computer-generated randomization list using Rv.0.1 software and by a block size of 4. Then, the allocation information (randomization results) was concealed in opaque and sealed envelopes by the statistician.
The study was blinded in regard of the statistical analysis. Data were recorded and blinded for the statistician: blinding was obtained by eliminating from the elaboration file every reference to patient group assignment
To determine the reliability of the method 15 radiographs chosen at random were traced and digitized by the same investigator on 2 separate occasions at least one month apart. A paired t-test was used to compare the two measurements (systematic error). The magnitude of the random error was calculated by using the method of moment's estimator (MME). Exploratory statistics revealed that not all cephalometric variables were normally distributed (Kolmogorov-Smirnov test) with equality of variances (Levene's test).Kruskal-Wallis test or ANOVA with Tukey's post-hoc tests were used to compare the T2-T1 changes in the three groups. All changes were considered significant at P<0.05. All statistical computations were performed with Statistical Package for the Social Sciences software (Version 12, Chicago, IL)..
10 randomized subjects will be included in the treated group 1, 10 randomized patients will be included in the treated group 2 and 10 randomized patients will be used as untreated control group.
The baseline age was 8.1 ± 0.6 years (range 6.6-9.1 years).
Sample size for this pilot trial was calculated according to the method proposed by Whitehead et al. For a standardized effect size of 1 (a clinically relevant change of 2.0 mm with a combined Standard Deviation of 2.0 mm derived from Guest et al.) for the 8 primary outcome variable Pogonion to Nasion perpendicular, a sample size of 10 subjects per group was required for a Type I error rate of 5% and a power of 80%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective 3-arm parallel group randomized clinical trial with a 1:1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Treated Group 1 | Active comparator | Device: Bonded RME (Rapid Maxillary Expander) appliancePatient treated with bonded RME (Rapid Maxillary Expander) with a 13-mm screw. The acrylic splints of the bonded expander extended from the first deciduous molars through the first permanent molars. |
| Treated Group 2 | Active comparator | Device: Banded RME (Rapid Maxillary Expander) appliancePatients treated with banded RME (Rapid Maxillary Expander) in the form of a butterfly palatal expander with a 13-mm screw cemented through bands on the second deciduous upper molars. |
| Untreated Control Group | No intervention | –Matched untreated Class II control group prospectively evaluated after one year |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- early mixed dentition with first molars fully erupted,
- Class II malocclusion (full-cusp or end-to-end molar relationships),
- negative posterior transverse interarch discrepancy ≥ 4 mm,
- Overjet ≥ 5 mm,
- and prepubertal stage of development (Cervical Stage 1 - Cervical Stage 2 in cervical vertebral maturation)
Key exclusion criteria (4 listed)
- previous orthodontic treatment,
- extracted or congenitally missing teeth,
- craniofacial syndromes or clefts,
- use of additional orthodontic devices during the observation period
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 |
|---|---|---|
| Bonded RME (Rapid Maxillary Expander) applianceThe expansion screw was activated 1 quarter of a turn per day (0.25 mm per turn) until the palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth. The expander was kept in place as a passive retainer for 8 months. After expander removal, patients were followed without performing any additional treatment for 4 months. | Device | Treated Group 1 |
| Banded RME (Rapid Maxillary Expander) applianceThe expansion screw was activated 1 quarter of a turn per day (0.25 mm per turn) until the palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth. The expander was kept in place as a passive retainer for 8 months. After expander removal, patients were followed without performing any additional treatment for 4 months. | Device | Treated Group 2 |
Primary outcome
Mandibular displacement after RME appliance therapy (linear measurement in millimeters) when compared with a matched untreated control group
Time frame: 12 months
The primary outcome was the change in the position of point Pogonion to the Nasion perpendicular (Pg to N perp). The objective is to evaluate the changes in the sagittal mandibular position induced by bonded or banded RMEs compared with an untreated control group. For each treated patient, standard lateral cephalograms were obtained before treatment and after 1 year to evaluate the dento-skeletal changes. The Control Group was followed up without treatment for 1 year and had lateral cephalograms before and after a one-year interval. Cephalograms were scanned using a professional table scanner (Epson Perfection V700 Photo, CA, USA), with resolution set to 150 dots per inch (dpi) gray scale and were digitized by 1 investigator., followed by a customized digitization regimen and analysis (Viewbox 3.1; dHAL Software, Kifissia, Greece). All cephalograms were at a magnification of 0%. The examiner was blinded to the origin of the films and the group to which each subject belonged
2 secondary outcomes
Occlusal improvement of Class II molar relationship after RME appliance therapy (linear measurement in millimeters) when compared with a matched untreated control group
Time frame: 12 months
Treatment effects on vertical dimension (SN-Go Me; angular measurement) and on Gonial Angle (Ar-Go-Me, angular measurement) and vertical growth pattern after RME appliance therapy when compared with a matched untreated control group
Time frame: 12 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 19 May 2017.
- Background: PubMed 19905846McNamara JA Jr, Sigler LM, Franchi L, Guest SS, Baccetti T. Changes in occlusal relationships in mixed dentition patients treated with rapid maxillary expansion. A prospective clinical study. Angle Orthod. 2010 Mar;80(2):230-8. doi: 10.2319/040309-192.1.
- Results publication: PubMed 25162569Baratieri C, Alves M Jr, Bolognese AM, Nojima MC, Nojima LI. Changes in skeletal and dental relationship in Class II Division I malocclusion after rapid maxillary expansion: a prospective study. Dental Press J Orthod. 2014 May-Jun;19(3):75-81. doi: 10.1590/2176-9451.19.3.075-081.oar.
- Results publication: PubMed 9155809Baccetti T, Franchi L, McNamara JA Jr, Tollaro I. Early dentofacial features of Class II malocclusion: a longitudinal study from the deciduous through the mixed dentition. Am J Orthod Dentofacial Orthop. 1997 May;111(5):502-9. doi: 10.1016/s0889-5406(97)70287-7.
- Results publication: PubMed 8876494Tollaro I, Baccetti T, Franchi L, Tanasescu CD. Role of posterior transverse interarch discrepancy in Class II, Division 1 malocclusion during the mixed dentition phase. Am J Orthod Dentofacial Orthop. 1996 Oct;110(4):417-22. doi: 10.1016/s0889-5406(96)70045-8.
- Results publication: PubMed 10799117McNamara JA. Maxillary transverse deficiency. Am J Orthod Dentofacial Orthop. 2000 May;117(5):567-70. doi: 10.1016/s0889-5406(00)70202-2. No abstract available.
- Results publication: PubMed 21055598Guest SS, McNamara JA Jr, Baccetti T, Franchi L. Improving Class II malocclusion as a side-effect of rapid maxillary expansion: a prospective clinical study. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):582-91. doi: 10.1016/j.ajodo.2008.12.026.
- Results publication: PubMed 15747809Wendling LK, McNamara JA Jr, Franchi L, Baccetti T. A prospective study of the short-term treatment effects of the acrylic-splint rapid maxillary expander combined with the lower Schwarz appliance. Angle Orthod. 2005 Jan;75(1):7-14. doi: 10.1043/0003-3219(2005)0752.0.CO;2.
- Results publication: PubMed 26516713Feres MF, Raza H, Alhadlaq A, El-Bialy T. Rapid maxillary expansion effects in Class II malocclusion: a systematic review. Angle Orthod. 2015 Nov;85(6):1070-9. doi: 10.2319/102514-768.1.
- Results publication: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Results publication: PubMed 21447784Springate SD. The effect of sample size and bias on the reliability of estimates of error: a comparative study of Dahlberg's formula. Eur J Orthod. 2012 Apr;34(2):158-63. doi: 10.1093/ejo/cjr010. Epub 2011 Mar 29.
- Results publication: PubMed 22011901Baratieri C, Alves M Jr, Sant'anna EF, Nojima Mda C, Nojima LI. 3D mandibular positioning after rapid maxillary expansion in Class II malocclusion. Braz Dent J. 2011;22(5):428-34. doi: 10.1590/s0103-64402011000500014.
- Results publication: PubMed 20197166Volk T, Sadowsky C, Begole EA, Boice P. Rapid palatal expansion for spontaneous Class II correction. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):310-5. doi: 10.1016/j.ajodo.2008.05.017.
- Individual participant dataSharing planned: No. no individual participant data are to be shared
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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.
Roberta Lione, Dentistry principal investigator
Research Fellow, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata," Rome, Italy, and research Fellow, Department of Dentistry, University Nostra Signora del Buon Consiglio, Tirana, Albania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bonded RME (Rapid Maxillary Expander) appliance and Banded RME (Rapid Maxillary Expander) appliance in people with Malocclusion, Angle Class II and Malocclusion, run by University of Rome Tor Vergata at 1 site in Italy.
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 5 inclusion and 4 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 19 May 2017. 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 Italy. 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?
Mandibular displacement after RME appliance therapy (linear measurement in millimeters) when compared with a matched untreated control group (time frame: 12 months). 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 NCT03159962, which also lists 15 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 19 May 2017.