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RESEARCH PROTOCOL Title Randomised clinical trial investigating the airway, facial, dental and skeletal changes from bone anchored and tooth anchored rapid palatal expansion (Hybrid-Hyrax) vs traditional rapid palatal expansion (Hyrax) vs a novel keyless palatal expansion deice (Keles). Shortened title RCT comparing three different expansion devices. Students Dr. Gordon CHEUNG (Post-graduate orthodontic registrar at University of Sydney) Dr. Shanya HAMMOND (Post-graduate orthodontic registrar at University of Sydney) Dr. Simone MUSTAC (Post-graduate orthodontic registrar at University of Sydney) To be known as researchers 1, 2 and 3 respectively. Supervisor Prof. M Ali DARENDELILER Associate Supervisors Dr. Oyku Dalci Dr. Alexandra Papadopoulou Version 1.3, 07/07/2017 1

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Page 1: Title - ANZCTR v1.3... · Web view12.Garrett BJ, Caruso JM, Rungcharassaeng K, Farrage JR, Kim JS, Taylor GD. Skeletal effects to the maxilla after rapid maxillary expansion assessed

RESEARCH PROTOCOLTitleRandomised clinical trial investigating the airway, facial, dental and skeletal changes from bone anchored and tooth anchored rapid palatal expansion (Hybrid-Hyrax) vs traditional rapid palatal expansion (Hyrax) vs a novel keyless palatal expansion deice (Keles).

Shortened titleRCT comparing three different expansion devices.

StudentsDr. Gordon CHEUNG (Post-graduate orthodontic registrar at University of Sydney)Dr. Shanya HAMMOND (Post-graduate orthodontic registrar at University of Sydney)Dr. Simone MUSTAC (Post-graduate orthodontic registrar at University of Sydney)To be known as researchers 1, 2 and 3 respectively.

SupervisorProf. M Ali DARENDELILER

Associate SupervisorsDr. Oyku DalciDr. Alexandra Papadopoulou

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Study BackgroundCurrently there is good evidence establishing that rapid palatal expansion (RPE) devices are a good device to use for patients with a maxillary transverse deficiency in relation to the mandible (1).

The most commonly used appliance is the Hyrax expander. This has bands on the maxillary first molars, and usually the maxillary first premolars, with a midpalatal screw. The screw functions as a jackscrew, where turning pushes two adjacent metal blocks in opposite direction. This in response exerts force through the lingual bars and molar bands to expand the palate. The screw is turned with a separate key.

Patients or parents have to insert the key into the hole and turn the screw to activate the expansion. This requires patients to activate the device by placing a key in a hole that is less than one millimeter in diameter and it is very common for patients/parents to have difficulty finding this hole intraorally. Other risks when activating include injuries to the palate from the insertion of the key and swallowing of the key. These complications decrease patient compliance and efficiency of palatal expansion. Other numerous disadvantages of this technique are well documented in the literature including limited skeletal changes (1), undesirable dental effects, root resorption (2), and long-term relapse of sutural expansion (3). Thus, alternative appliances have been proposed.

The Keles expander proposes to simplify the expansion procedure for patients through a built-in activation arm. This is the only difference between the traditional design and the Keles expander as they are both tooth supported with no miniscrew support. The Keles design has been shown in case reports to show effective palatal expansion, however no randomized control study has been done to compare its effectiveness compared to traditional devices.

Temporary anchorage devices (TADs) are a relatively recent introduction to the orthodontist’s armamentarium. They allow absolute skeletal anchorage, thereby allowing the orthodontist to transfer force directly to bone rather than just teeth. This has opened up a variety of different treatment possibilities including the introduction of a micro-implant assisted rapid palatal expander (MARPE) which incorporates temporary anchorage devices, in the form of mini-screws, inserted into the posterior region of the palate with the purpose of minimizing dento-alveolar effects and maximizing skeletal effects.

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Picture of Hyrax expander Picture of key used to activate Hyrax

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Picture of MARPE appliance (4)

To date there is only one randomized control trial, which compared a MARPE and Hyrax expander (4). Multiple case studies have been published (5, 6), and it has been suggested that the MARPE design is beneficial in patients with greater fusion of the sutures and dolichofacial patients (7). However, this appliance has significant disadvantages including the risk of lesions to the roots of teeth during placement of the mini-screws into the posterior alveolar process (8). This led to the development of the Hybrid-Hyrax.

The Hybrid-Hyrax is a combination of the two above techniques, with the hyrax expansion screw attached to both the maxillary first molars and two TADs. The miniscrews are inserted into the middle of the anterior palate, where bone is ample. This appliance is a good combination between the traditional Hyrax and the MARPE, and theoretically should take advantage of both appliances. Research has demonstrated that the Hybrid-Hyrax is an efficient means of achieving RPE and has application in the following situations: where anterior dental anchorage is lacking, patients requiring early Class III treatment with a facemask and where minimization of dental effects is desirable (8). However, there are no randomized control trials comparing this to alternative expansion devices. Thus, there is a significant lack of knowledge in the orthodontic community in regards to the differences in outcomes, and clinical indications, for the Hybrid-Hyrax expander versus traditional Hyrax expander.

Existing literature has shown that Cone Beam Computer-tomography (CBCT) has much lower radiation doses compared to conventional Multi-slice computer tomography (MSCT). In addition, it allows more accurate and comprehensive three-dimensional analysis of RPE effects as compared to two-dimensional radiographic images. Therefore, CBCT will be used in our study to evaluate the dental and skeletal effects of RPE. Our study will compare the Keles Keyless expander with the most commonly used expander, the Hyrax expander and the Hybrid-Hyrax expander.

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Picture of Hybrid-Hyrax appliance

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Current literature recognizes that the most accurate way to assess soft tissue changes is to use a 3D examination, of which 3D sterophotogrammetric images are preferential to assess the soft tissues (9). It is established that as RPE alters the hard tissues, it has the potential to change the overlying soft tissues. A handful of studies have investigated the soft tissue changes following RPE (9, 10)

It is recognized that variations in the soft tissue response can be observed with different rapid palatal expansion appliances. Bonded Hyrax appliances have been shown to result in less anterior and downward maxillary movement than bonded Hyrax appliances (11). However, there is no research comparing the soft tissue differences between purely tooth-bourne expanders and bone and tooth-bourne expanders for rapid palatal expansion. However, soft tissue differences should be expected, as there are hard tissue differences between the appliances (7). Thus, this is an area that requires investigation.

Groups Three groups

o Control group (arm 1): 20 patients treated with Hyrax

o Experimental group (arm 2): 20 patients treated with Hybrid-Hyrax

o Experimental group (arm 3): 20 patients treated with Keles expander

AppliancesHyrax expander (arm 1) Hybrid-Hyrax expander (arm 2) Keles expander (arm 3)

Description Most commonly used appliance for rapid maxillary expansion.

Midpalatal screw which functions as a jackscrew, where turning the screw pushes two adjacent metal blocks in opposite direction. This in response exerts force through the lingual bars and molar bands on teeth to expand the palate.

The screw is turned with a separate key. Patients or parents have to insert the key into the hole and turn the screw to activate the expansion

Has two palatal mini-screws. Mini-screws allow absolute

skeletal anchorage, thereby allowing the orthodontist to transfer force directly to bone rather than just teeth

Midpalatal screw is attached to the mini-screws as well as to the bands on the maxillary first molars.

Midpalatal screw is the same as the Hyrax expander.

Has a built-in activation arm.

This is the only difference between the traditional Hyrax expander.

Use of mini-

Not required Two temporary anchorage devices (in form of mini-screws)

Not required

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screws placed in palate requiredSupport Tooth supported Tooth and bone supported Tooth supportedUse of topical and local anesthetic

Not required Required for placement of mini-implants

Not required

Activation The screw is turned with a separate key. Patients or parents have to insert the key into the hole and turn the screw to activate the expansion

The screw is turned with a separate key. Patients or parents have to insert the key into the hole and turn the screw to activate the expansion

The screw is turned by the built-in activation arm and has a self-locking mechanism to prevent retraction of blocks.

Rate of expansion

0.2mm per turn 2 x turns per night until

adequate expansion achieved

0.2mm per turn 2 x turns per night until

adequate expansion achieved

0.2mm per turn 2 x turns per night until

adequate expansion achieved

Current clinical usage

Currently the standard orthodontic appliance for rapid palatal expansion

Currently an alternative standard orthodontic appliance for rapid palatal expansion.

Less common use than Hyrax expander.

Novel appliance, not yet in standard orthodontic use

Currently undergoing clinical trial by Dr Mohamed Masoud at Harvard University

Been used in numerous case reports

Photograph

Aims and hypothesis of the studyTo evaluate the efficacy of different types of expanders (Hyrax vs Hybrid-Hyrax vs Keles expander) on the rapid palatal expansion, improvement of the airways and soft tissue changes (including improvement on asymmetry).

Primary outcomes - Skeletal and Dental Effects

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Figure 1: Image from Lin 2015 showing transverse measurements from the CBCT of the A) skeletal widths B) dental widths

Figure 2 B) tooth inclinations (palatal root axis and NF)

Skeletal: maxillary width o Changes in nasal floor width (NF): (See Figure 1A)

Definition: maxillary width parallel to the lower border of the hard palate and tangent to the nasal floor at its most superior level

The expected numerical value may vary between the 0.5-2.5mm.

A clinically significant difference would be approximately 2mm

o Changes in hard palate width (HP): (See Figure 1A) Definition: maxillary width parallel to the lower

border of the hard palate and tangent to the hard palate

The expected numerical value would vary between 0.5-3mm

A clinically significant difference would be approximately 2mm

Dental:o Changes between first molar width using pulp chamber

(PC): (See Figure 1B) Definition: distance between pulp chambers The expected numerical value would vary between

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1.5-3mm A clinically significant difference would be

approximately 2mmo Changes in angulation of palatal root to palatal plane (Tor)

- (See Figure 2B) Definition: changes in inclination of palatal root axis

of molar to palatal plane The expected numerical value may vary between 0-

7° A clinically significant difference would be 2°

1) Secondary outcomes: To evaluate and compare the effect on the airway of rapid palatal expansion using standard orthodontic records (including CBCT)

a. Between arm 1 and arm 2i. We anticipate there will be a statistically significant

difference with the Hybrid-Hyrax producing greater effects on the airway.

b. To be analysed by Researcher 12) To evaluate and compare the effect on soft tissues, in particular

asymmetry, from rapid palatal expansion using 3dMD and standard orthodontic records (including CBCT)

a. Between arm 1 and arm 2i. We anticipate there will be a statistically significant

difference with the Hybrid-Hyrax producing greater effects on the soft tissue and greater improvement of asymmetry.

b. To be analysed by Researcher 33) To evaluate and compare the ease of use and patient compliance

using questionaries.a. Between arm 1 and arm 2

i. We anticipate there will not be a statistically significant difference

b. Between arm 1 and arm 3i. We anticipate there will be a statistically significant

difference with the Keles expander resulting in greater compliance and ease of use

c. Between arm 2 and arm 3i. We anticipate there will be a statistically significant

difference with the Keles expander resulting in greater compliance and ease of use

d. To be analysed by Researchers 1, 2 and 34) To evaluate and compare the effects on circummaxillary sutures of

rapid palatal expansion using standard orthodontic records (including CBCT)

a. Between arm 1 and arm 2i. We anticipate there will be a statistically significant

difference with the Hybrid-Hyrax producing greater effects on the circummaxillary sutures.

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b. To be analysed by Researcher 2

Significance of the aimsThe results will determine if one appliance has significant benefit over the other in regards to the dental, skeletal and soft tissue effects, ease of use and compliance, airway improvements and effects on circummaxillary sutures and asymmetry. Knowledge of this would help the clinician determine which appliance is more patient-friendly, clinically effective and efficient, improving the overall experience for both the orthodontists and patients.

Study DesignRecent Cohort studies and Randomized control trials assessing the effects of expansion have used sample sizes ranging from 15 to 21 per group. To increase the strength of our own study, we will recruit 20 per group. These will be randomly allocated by an independent person, into one of three groups. All patients that will be recruited will be patients that are currently on the waitlist for Orthodontic treatment at the Sydney Dental Hospital.

Three groupso Control group (arm 1):

20 patients treated with Hyraxo Experimental group (arm 2):

20 patients treated with Hybrid-Hyraxo Experimental group (arm 3):

20 patients treated with Keles expander Inclusion/exclusion criteria

o Age: 10-16 years old Chosen as rapid palatal expansion is routine treatment in patients

of this age range. o Patients with maxillary transverse deficiency and need for orthodontic

correction as demonstrated by a posterior crossbite and/or narrow palatal width

Picture demonstrating patient with a narrow palate and maxillary transverse deficiency

o Transverse discrepancy between the maxilla and mandible to be more than 5mm as measured from the upper first molar palatal cusp tips to the lower first molar groove

o Erupted permanent maxillary first molars and first premolars Exclusion criteria

o Unerupted permanent maxillary first premolars or first molarso History of previous orthodontic treatmento Women who are pregnant

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o People with an intellectual or mental impairmento People highly dependent on medical careo History of congenital deformityo Periodontal diseaseo Surgical treatment that may affect the rapid maxillary expansion outcome

Expansion protocolo Determining amount of expansion required

Measure from mesial-palatal cusp of 16 to 26 and compare to central groove of 36 to 46.

Calculate the difference to determine expansion required. o 2 turns/day to be completed at night.

Appointment scheduleThe following outlines the appointment visits and clinical procedures of this research:Screening

1) Recruitment Waiting List Officer in Patient Flow Unit to contact appropriate patients for screening via letter. Patients to respond to letter if interested in attending screening appointment via phone call. Appointment booked for screening by Waiting List Officer with either researcher 1, 2 or 3

2) Screening and information appointment Patient attends screening appointment with guardian (if applicable). Medical history and dental history collected. Clinical examination completed to assess if patient is applicable for study.

a. If patient not suitable for study, reasons will be discussed with the patient and patient will be placed back onto the waitlist (in their original position)

b. If patient is suitable for study, in-depth discussion of study will be provided by either researcher 1, 2 or 3. Patient will also be provided with an information sheet. Discussion will include:

i. Voluntary participation including 1. Decision will not affect treatment, position on waitlist for

treatment or relationship with staff caring for patient2. Ability to withdraw at any time without a reason. 3. No cost of participating in study

ii. Potential risks of study as outlined in information sheetsiii. Benefits of studyiv. Confidentialityv. Outline of procedure including description of visits

c. If decision to participate in study, another appointment will be scheduled by Waiting List Officer

3) Consent appointment a. Consent forms will be completedb. Standard orthodontic records will be completed including:

i. Traditional photographsii. Impressions of upper and lower dentition

iii. Radiographs in the form of CBCT using Newtom 5G machine.

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1. The scanning protocol is as follows: 110 kV and 20 mA by using the following protocol: 18 x 16 cm field of view, 0.3 mm voxel size, and 3.6 seconds per section.

2. The scans will be taken with the patient lying in a supine position with the Frankfort horizontal plane perpendicular to the floor.

c. The only additional record to be obtained is 3D photographs via 3DMDi. Capture speed: approximately 1.5 millisecondii. Subject capture: 180-degree face capture (ear-to-ear)

iii. Configuration: two modular units of six machine vision cameras an industrial-grade flash system synchronized in a single capture

iv. Non-invasive modality: 1. Used alone: accurately documents the patient’s natural head

position and multiple facial expressions noninvasively 2. Can be combined with CBCT for better soft tissue accuracy

v. Speed: 7 second image capture

Image of a 3dMD reconstruction

Picture of the 3DMD machine

d. Patients will be randomly allocated to one of the three arms by Associate Supervisors using a random number generator

i. We will allocate each patient a number from 1-75, and then utilising the following (randomizer.org) we will randomly generate the three treatment arms with these allocated numbers.

ii. A demonstration of the randomisation is below

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iii. Blinding of this study is not possible due to the nature of the appliances

TreatmentThe patients in this study will undergo standard orthodontic treatment for rapid palatal expansion. The only addition is the collection of 3dMD records at time periods specified. All treatment will be completed by researches 1, 2 and 3. Each research will be allocated one third of the patients from each arm. All researchers will follow standard treatment protocols as specified below.

1) Visit 1 (separators): week 0Arms 1 and 3

Placement of eight separators for maxillary first premolars and maxillary first molars

Oral hygiene instructions and demonstration providedArm 2

Placement of four separators for maxillary first molars Oral hygiene instructions and demonstration provided

2) Visit 2 (impressions and placement of TADs): week 1Arms 1 and 3

Removal of separators and trial of molar bands on maxillary first premolars and maxillary first molars until appropriate size selected.

Impression of maxilla with bands in-situ and both impression and bands sent to lab.

Replacement of eight separators for maxillary first premolar and first molars.Arm 2

Removal of separators and trial of molar bands on maxillary first molars until appropriate size selected.

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Topical anaesthetic followed by 1.1ml of 2% lignocaine, 1:80k adrenaline in palatal infiltration

Palate cleaned with chlorhexidine mouthwash on gauze. Insertion of TADs (8):

o Soft tissue thickness to be measured with a dental probe to identify a region with thin mucosa coverage

o Position of TADs: at the third rugae, bilateral to the mid-palatal suture, with a minimum of 5mm and maximum of 10mm between the TADs.

o 2 x 9mm Benefit TADs (Mondeal, Mühlheim an der Donau, Germany) to be inserted with manual contra-angle handpiece at ninety degrees to surface

Picture demonstrating two palatal temporary anchorage devices

o Impression copings placed over TADs with dental floss attachedo Alginate impression of the maxillao Impression to be completed by insertion of lab analogues into

transfer caps and insertion of molar bands. o Impression sent to lab.

Picture demonstrating lab cast with molar bands and lab analogues where TADs were placed

Replacement of four separators for maxillary first molars. Home care instructions provided including:

o Chlorhexidine mouthwash: twice daily for five days3) Visit 3 (cementation): week 3

Arms 1, 2 and 3: The separators will be removed, and the expander will be cemented with resin-modified glass ionomer cement (RMGIC).

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Arm 2: The expander will also be attached to the TADs

All patients will be instructed to perform the expansion using expansion key twice a day in the evening. Information given on how to maintain appliance and oral hygiene.

Questionnaire one to be completed regarding ease of use and comfort of the appliance.

4) Visit 4 (one week review): week 4 Review of expansion appliance to ensure activation is being completed

correctly. Questionnaire two to be completed regarding ease of use and comfort of the

appliance. 5) Visit 5/6 (two and three week reviews): week 5/6

Weekly review to assess amount of expansion. Questionnaire two to be completed again regarding ease of use and comfort

of the appliance. If expansion is adequate then

Arms 1 and 2: Appliance will then be inactivated by Researcher with flowable composite inserted into expansion hole and cured with curing light. This requires no additional intervention from the patient.

If expansion is inadequate then weekly reviews to continue until expansion adequate.

6) Visit 7 (three month review): week 17/18. Assess appliance for breakage and to re-inforce oral hygiene.

7) Visit 8 (six month review and appliance removal): week 29/30. Appliance phase of treatment is now completed Arms 1, 2 and 3:

o Expansion appliance removed with band remover. Remaining RMGIC to be removed with slow-speed handpiece with tungsten carbide bur, and ultrasonic scaler.

o Oral hygiene instructions to be provided. Arm 2:

o TADs to be removed with hand-piece. o Chlorhexidine mouthwash on gauze to be used before and after TAD

removal.

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Picture demonstrating Hybrid-Hyrax after cementation

Keles expander after cementation

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Standard records will be taken i.e. traditional photographs, 3D photographs, impressions of the upper and lower teeth

3D photography in the form of 3DMD also to be completed No radiographs at this appointment

8) Visit 9 (three month post-retention review): week 41/42 Standard records will be taken including

o Traditional photographso Impressions of the upper and lower teetho Radiographs in the form of cone-beam computer tomography

In addition, 3D photography in the form of 3DMD also to be completedThe research procedures will be finished at this point but his/her standard orthodontic care will continue as needed by post-graduate orthodontic registrars.

Cone-beam computed tomograph (CBCT) protocolCone-beam computed tomography will be taken at T0 (pre-treatment), and T2 (9 months post-treatment) as per standard orthodontic records.

Patients will be scanned in a supine position and reconstruction of slices will be 0.5mm thick. Dental and skeletal measurements will be completed with linear measurements as described by Kartalian (2010) and Garrett (2008) (12, 13). Angular measurements will be completed as described by Kartalian (2010) (13). Measurements of the buccal and palatal alveolar widths will be completed as described by Baysal (2013) (14). The presence of any dehiscence and fenestrations will be evaluated as described by Evangelista (2010) (15). Sutural expansion and overall orthopaedic expansion will be measured as described by Garrett (2008) (12).

Airway assessment will be completed as described by Smith (2012) (16).

3D surface imaging system (3DMD) protocol3DMD will be taken at T0 (pre-treatment), at T1 (immediately post-treatment) and T2 (9 months post-treatment). Patients will be scanned in natural head position. Soft-tissue changes will be evaluated as described by Papasikos (2013) (17).

Data AnalysisMeasurement values will be determined by repeated measurements of 10 randomly selected samples measured 6 weeks apart. Intraclass correlation coefficient (ICC) will be used to assess intraexaminer reliability. Repeated-measures multivariate analysis of variance (ANOVA) will be applied to distances and angles in each dimension to determine statistical significance. A similar ANOVA test will be used to assess the visual analog scale on the questionnaire to determine the influence on appliance on patient perceptions.

References1. Lagravere MO, Heo G, Major PW, Flores-Mir C. Meta-analysis of immediate changes with rapid maxillary expansion treatment. The Journal of the American Dental Association. 2006;137(1):44-53.

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2. Erverdi N, Okar I, Kücükkeles N, Arbak S. A comparison of two different rapid palatal expansion techniques from the point of root resorption. American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics. 1994;106(1):47.3. Marshall SD, Shroff B. Long-term Skeletal Changes with Rapid Maxillary Expansion: A Review of the Literature. Seminars in Orthodontics. 2012;18(2):128.4. Lagravère MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: A randomized clinical trial. American Journal of Orthodontics and Dentofacial Orthopedics. 2010;137(3):304.e1-.e12.5. Tausche E, Hansen L, Schneider M, Harzer W. [Bone-supported rapid maxillary expansion with an implant-borne Hyrax screw: the Dresden Distractor]. L' Orthodontie francaise. 2008;79(2):127-35.6. Garib DG, Navarro RDL, Francischone CE, Oltramari PVP. Rapid maxillary expansion using palatal implants. Journal of clinical orthodontics : JCO. 2008;42(11):665.7. MacGinnis M, Chu H, Youssef G, Wu KW, Machado AW, Moon W. The effects of micro-implant assisted rapid palatal expansion (MARPE) on the nasomaxillary complex—a finite element method (FEM) analysis. Progress in Orthodontics. 2014;15(1):1-15.8. Wilmes B, Nienkemper M, Drescher D. Application and effectiveness of a mini-implant- and tooth-borne rapid palatal expansion device: the hybrid hyrax. World journal of orthodontics. 2010;11(4):323.9. Dindaroğlu F, Duran GS, Görgülü S. Effects of rapid maxillary expansion on facial soft tissues: Deviation analysis on three-dimensional images. Journal of Orofacial Orthopedics / Fortschritte der Kieferorthopädie. 2016;77(4):242-50.10. Ong SC, Khambay BS, McDonald JP, Cross DL, Brocklebank LM, Ju X. The novel use of three-dimensional surface models to quantify and visualise the immediate changes of the mid-facial skeleton following rapid maxillary expansion. The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland. 2015;13(3):132-8.11. Sarver DM, Johnston MW. Skeletal changes in vertical and anterior displacement of the maxilla with bonded rapid palatal expansion appliances. American Journal of Orthodontics & Dentofacial Orthopedics. 1989;95(6):462-6.12. Garrett BJ, Caruso JM, Rungcharassaeng K, Farrage JR, Kim JS, Taylor GD. Skeletal effects to the maxilla after rapid maxillary expansion assessed with cone-beam computed tomography. American Journal of Orthodontics and Dentofacial Orthopedics. 2008;134(1):8.13. Kartalian A, Gohl E, Adamian M, Enciso R. Cone-beam computerized tomography evaluation of the maxillary dentoskeletal complex after rapid palatal expansion. American Journal of Orthodontics & Dentofacial Orthopedics. 2010;138(4):486-92.14. Baysal A, Uysal T, Veli I, Ozer T, Karadede I, Hekimoglu S. Evaluation of alveolar bone loss following rapid maxillary expansion using cone-beam computed tomography. The Korean Journal of Orthodontics. 2013;43(2):83-95.15. Evangelista K, Vasconcelos KdF, Bumann A, Hirsch E, Nitka M, Silva MAG. Dehiscence and fenestration in patients with Class I and Class II Division 1 malocclusion assessed with cone-beam computed tomography. American Journal of Orthodontics & Dentofacial Orthopedics. 2010;138(2):133.e1-.e7.16. Smith T, Ghoneima A, Stewart K, Liu S, Eckert G, Halum S, et al. Three-dimensional computed tomography analysis of airway volume changes after rapid maxillary expansion. American Journal of Orthodontics and Dentofacial Orthopedics. 2012;141(5):618-26.

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17. Papasikos JJ. Three-dimensional evaluation of soft-tissue changes in extraction and non-extraction treatment of Class II high and low mandibular plane angle orthodontic patients: ProQuest Dissertations Publishing; 2013.

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