Mandibular Response After Maxillary Orthopedic Expansion in Class II Growing Subjects

NCT03159962 | Completed DMC

• 1 other identifier: 130/14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Malocclusion, Angle Class II; Malocclusion

Keywords

Rapid maxillary expansion; Mandibular response; Class II malocclusion; Growing subjects

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  12 months

Study Arms (3)

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.

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.

Device: Banded RME (Rapid Maxillary Expander) appliance

Untreated Control Group

NO INTERVENTION

Matched untreated Class II control group prospectively evaluated after one year

Interventions

Bonded RME (Rapid Maxillary Expander) appliance DEVICE

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.

Treated Group 1

Banded RME (Rapid Maxillary Expander) appliance DEVICE

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.

Treated Group 2

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• previous orthodontic treatment,
• extracted or congenitally missing teeth,
• craniofacial syndromes or clefts,
• use of additional orthodontic devices during the observation period

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

University of Rome "Tor Vergata"

Rome, 00133, Italy

Location

Related Publications (15)

• 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.

  PMID: 19905846 BACKGROUND

• Baratieri 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.

  PMID: 25162569 RESULT

• Baccetti 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.

  PMID: 9155809 RESULT

• Tollaro 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.

  PMID: 8876494 RESULT

• McNamara 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.

  PMID: 10799117 RESULT

• Guest 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.

  PMID: 21055598 RESULT

• Wendling 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.

  PMID: 15747809 RESULT

• Feres 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.

  PMID: 26516713 RESULT

• Whitehead 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.

  PMID: 26092476 RESULT

• Springate 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.

  PMID: 21447784 RESULT

• Baratieri 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.

  PMID: 22011901 RESULT

• Volk 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.

  PMID: 20197166 RESULT

• Schulz 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.

  PMID: 16168329 RESULT

• Asanza 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.

  PMID: 9046395 RESULT

• Lione 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.

  PMID: 29105023 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II; Malocclusion; Overbite

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Roberta Lione, Dentistry

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Research Fellow, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata," Rome, Italy

Model Details: prospective 3-arm parallel group randomized clinical trial with a 1:1:1 allocation ratio

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 19, 2017
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2016
• Last Updated: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)