Evaluation of The Treatment Outcome of Cleft Palate Patients Treated with Differential Opening Expander with Alt-RAMEC Protocol and Facemask : (a cohort clinical study )

doi:10.21203/rs.3.rs-2466908/v1

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Evaluation of The Treatment Outcome of Cleft Palate Patients Treated with Differential Opening Expander with Alt-RAMEC Protocol and Facemask : (a cohort clinical study )

https://doi.org/10.21203/rs.3.rs-2466908/v1

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Objectives: The purpose of this study was to assess the effectiveness of the expander with differential opening (EDO) with alternate rapid maxillary expansion and contraction (Alt-RAMEC), and Facemask Protraction in patients with cleft lip and palate using cone beam computed tomography (CBCT) records.

Material and methods: Eight cleft lip and palate patients, ages 8 to12 years, were selected. All patients had maxillary permanent first molars and displayed a constricted maxillary arch, Primary lip adhesion and palatal closure were done in early childhood. All patients treated with the Alt-RAMEC protocol used EDO and a protraction facemask. CBCT scans were taken both before and six months after treatment. Maxillary transverse dimensions were measured, including the nasal cavity width, maxillary width, alveolar crest width, arch width, inclination of the molar teeth, alveolar width, alveolar crest level, and buccal and palatal bone plate thickness. A paired sample t-test for significance was used when comparing related samples. Pearson's correlation coefficient (r) test was used to assess the degree of association between two sets of variables.

Results: All maxillary transverse measurements increased significantly at the molar and premolar regions (p<0.05). Alveolar crest level and buccal bone plate thickness were slightly decreased (0.57mm) and 0.5 mm, respectively; (p<0.05). The molar teeth showed a significant increase in buccal inclination (6.36°) (P<0.001). Forward movement of the maxilla was seen in lateral cephalometric extracted from CBCT.

Conclusion: Significant maxillary expansion and advancement were achieved while using the EDO with Alt-RAMEC and facemask protraction, while there was a slight decrease in buccal bone thickness and height and significant increase in buccal molar inclination.

Registration : This trial was registered in the ClinicalTrials.gov Identifier: NCT04970095 and the date of registration was July 16, 2021.

Clinical Relevance: This innovative treatment approach corrects anterior and posterior crossbite in patients with cleft lip and palate who have dentoskeletal anomalies.

Expansion

Cleft lip and palate

Alt-RAMEC

Facemask

EDO

Cleft lip and palate (CLP) anomalies are the most prevalent among all craniofacial anomalies, affecting one in every 700 births and disturbing the quality of life of more than 7 million people around the world [1].

Clefts patients are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty and severe transverse maxillary constriction and anteroposterior deficiency class Ⅲ malocclusion [2].

The goals of early treatment of clefts patients generally include enhancing forward and transverse maxillary growth. A treatment protocol including combined face mask and maxillary expansion [3].

Transverse maxillary constriction can be improved by various appliances and treatment protocol, Hass, Fan-shaped or Hyrax with rapid maxillary expansion or slow maxillary expansion or alternate rapid maxillary expansion and constriction (ALT-RAMEC) [4].

Conventional rapid maxillary expansion (RME) expansion with Hyrax or Hass produces similar transversal increases in the anterior and posterior regions of the maxillary dental arch, risking overexpansion of the intermolar distance to correct the intercanine distance. On the other hand, The Fan-type expanders has a posterior hinge that concentrates the expansion effect in the intercanine region, with mild effects in the intermolar distance [5-7]. So, when maxillary constriction is more evident in the anterior region of the arch, the fan-type expander (FE) or the expander with differential opening (EDO) can be indicated [7,8].

An expander with differential opening (EDO) has 2 parallel-opening screws, one anteriorly and one posteriorly positioned in the palate were designed especially for achieving different amounts of expansion in the anterior and posterior regions of the maxillary dental arch in patients with cleft lip and palate [8,9].

Studies that comparing the Hyrax expander and the EDO in cleft patient showed that the EDO promoted greater expansion in the anterior region of the maxillary dental arch than hyrax [10].

Other comparison between the EDO and the FE showed that the EDO showed greater transverse skeletal expansion compared to the FE, with similar vertical and anteroposterior effects and greater dentoalveolar expansion in the molar region, while the FE produced greater increase in intercanine distance [11,12].

To enhance forward maxillary movement protraction face mask was used. In (1982) introduced the concept of maxillary expansion (ME) to be used in conjunction with the protraction face mask [13]. It worked on the principle of disarticulating the maxilla from the neighbouring bones which are connected by circum-maxillary sutures thus bringing it forward using protraction face mask easier. Different articles published the amount of expansion required to disarticulate maxilla. Hass suggested that 5 mm of expansion was enough [14] but Alcan suggested that a minimum of 12 to 15 mm was required [15], expanding the maxilla beyond 15 mm is not acceptance clinically or practical. so Liou (2005) introduced Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) technique to loosen the circum-maxillary sutures, help to advance the maxilla in patients with cleft lip and palate [16].

It enables sutural mobilization with the opening and closing of the rapid maxillary expansion RME screw for 7 consecutive weeks. It is like to simple tooth extraction in which we repeatedly rock the tooth buccally and lingually until the tooth is “disarticulated” out of the alveolar socket.

With the advent of cone-beam computed tomography (CBCT) in dentistry, this study was performed to assess evaluate the effect of the expander with differential opening and facemask therapy with the Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC protocol to achieve maxillary expansion and protraction in cleft lip and palate patients.

Study design:

Randomized clinical trial (RCT).

Ethical consideration

The objectives of the study were discussed with the parents and written informed consent form was signed from the participants’ parents or legal guardians before intervention the orthodontic treatment.

Patient selection:

A randomly selected sample of 8 patients with cleft lip and palate (4 males and 4 females) were taken from the Orthodontic clinic, in the Faculty of Dental Medicine for Girls and Al-Azhar Cleft Lip and Palate Treatment Center, at Al-Azhar University in Cairo, Egypt.

Sample size estimation and statistical power

The calculation was estimated using CDC Epi Info program version 7.2.0.1 (Atlanta, USA) assuming a power of 80% and alpha=0.05 to detect amount of expansion of palate using differential opening expander and alternative rapid maxillary expansion and contraction protocol among cleft lip and palate patients.

A total sample of 8 consecutive patients is needed based on an estimated 85.7% obtained improvement in occlusal index according to Terumi Ozawa et al. et al 2020[16].

Inclusion criteria

Patients of both sexes.
Cleft lip and palate patients.
All patient age ranges from 8 to 12 years.
All cases showed maxillary arch constriction and deficiently
All patients had maxillary permanent first molars.
Primary lip adhesion and palatal closure was done early childhood.

Exclusion criteria:

Patients had received any surgical assisted expansion or maxillary protraction or fixed orthodontics before.
Maxillary dentition unsuitable to bond the expander (less than two dental unit bedside first permanent molar).
Absent maxillary permanent first molars.
Uncooperative patients/parents

Fabrication of Expander with Differential Opening (EDO) appliance

After Separation and band selection impression taking and the cast was pouring, the tooth borne- banded and bonded Maxillary Expander with Differential Opening (EDO) appliance¹ was fabricated for each patient (Fig 1, A) [10]. The body of the appliance was placed flush against to the palate with the clearance about 1-2mm between the appliance and the palate. The anterior screw of EDO was placed anteriorly as much as possible, and the posterior screw of EDO was placed mesial to the maxillary first molar. The posterior 2 arms were contoured, adapted, and cut to be in contact with the two band on the upper first permanent molar bilaterally on the working model, then soldered from the palatal side of the molar bands with silver solder. The anterior 2 arms were contoured, adapted, and embedded in acrylic plate. Occlusal surfaces of the teeth were coated with acrylic resin (1-2 mm thickness) to enlarge the surface area of the appliance for improved cement adhesion and to eliminate occlusal interferences in the anterior region. Red mark was draw on the acrylic occlusal surface upon the palatal cusp of maxillary teeth to facilitate the identification of over correction when the palatal cusp of maxillary teeth occludes with buccal cusp of mandibular teeth. A facemask hook was added in the region of the maxillary canine area and position the facemask hooks vertically around canines and as superior as possible.

ALT-RAMEC protocol

Patient will be treated for 7 weeks [18].
Expansion or constriction rate will be 4 times per day (1mm per day 1/4 turn) for both screws two ¼ turns in the morning and two ¼ turns in the evening.
The sequences will be (first week :7 days of expansion), (second week: 7 days of constriction), (third week:7 days of expansion), (fourth week :7 days of constriction), (fifth week :7 days of expansion),( sixth week:7 days of constriction), ( seventh week:7 days of expansion).
The patient will come every week to ensure correct operation.
The width between arms of expander will measure during every weekly visit
Then expansion will continue unlit over corrected of posterior cross bite until palatal cusp tips of the maxillary posterior teeth occluded opposite the buccal cusp tips of the mandibular posterior ones.
If anterior cross bite still present, the anterior screw only will be activated (4 times a day) until over corrected of anterior cross bite.
After completion of expansion the appliance was fixed using flowable composite (Fig 1, B).

Face mask protocol

During phase of expansion, the patient was be treated by petit facemask** maxillary protraction (Fig 2,3).
A facemask has horizontal bar for elastic (ORMCO Z-pak elastics (3/8”) 14 Oz).
Adjust the horizontal bar of the facemask according to growth pattern of each patient. If we require downward and forward movement of maxilla, adjust horizontal bar little downward direction against lower lip (20-40 degree to occlusal plane). If we require only forward movement of maxilla, adjust horizontal bar more superiorly against upper lip (less than 20 degree to occlusal plane).
Delivering force 400 to 500 gram per side.
The patient will wear the facemask 16 hours a day.
The protraction facemask therapy continued until a 2 mm overjet.

After the expansion active phase (7weeks), the screw was fixed with acrylic resin, and the appliances were kept in the dental arch and the facemask was worn at sleep for 6 months as retainers. Cone beam computed tomography (CBCT) was obtained before expansion and 6 months post expansion, after appliance removal.

Images were obtained with a Planmeca machine*** and the technical parameters for image acquisition were 90 kV, 12 mA, image size 20×20 cm, and voxel size of 200 µm for each patient. For image acquisition, the patients were sitting, the Frankfort horizontal plane was parallel to the ground and the median sagittal plane was perpendicular to the ground.

Superimposition of the CBCT 3D surface models

The Digital Imaging and Communications in Medicine (DICOM) data resulting from each CBCT scan were exported and analyzed by specialized software Invivo dental software version 5.2 (Anatomage Inc., San Jose, CA) for a three-dimensional superimposition. For superimposition, the anterior cranial base and the occipital area posterior of the foramen magnum were selected as the stable structures.

CBCT measurement

The ALT-RAMEC expansion protocol and face mask effects were examined to compare the measurements made at T0 and T1 in all three planes of space.

The changes on the liner and angular transverse dimension were evaluated with coronal and axial cuts. The transverse posterior maxillary measurements were registered on the permanent first molars (Fig 4,5), and the transverse anterior measurements were recorded at the level of the most anterior appliance-supporting teeth (Fig 6).
The changes in the anteroposterior plane were assessed using the SNA angle, SNB angle and ANB angle measured in the lateral cephalograms obtained from the CBCT scans (Fig 7).

Statistical analysis

Recorded data were analyzed using the statistical package for social sciences, version 23.0 (SPSS Inc., Chicago, Illinois, USA). The quantitative data were presented as mean± standard deviation and ranges. Also, qualitative variables were presented as number and percentages.

The following tests were done:

Paired sample t-test of significance was used when comparing between related sample.
Pearson's correlation coefficient (r) test was used to assess the degree of association between two sets of variables The paired t test was also used to evaluate differences in transverse changes between the anterior and posterior regions.
The confidence interval was set to 95% and the margin of error accepted was set to 5%. So, the p-value was considered significant as the following:
Probability (P-value)
P-value <05 was considered significant.
P-value <001 was considered as highly significant.
P-value >0.05 was considered insignificant

[1]Great Lakes Orthodontics, Tonawanda, NY; www.greatlakes

ortho.com.

** (GAC Bohemia, NY, USA)

*** (Planmeca ProMax® 3D Plus, Finland, USA)

This study included 8 cleft lip and palate patients. The patient’s age ranged from 8 to 12 years with mean (±) SD of 10.88±1.36. As regards sex distribution, there was matched female and male (50%) of each type (Table1).

Table 1 Baseline characteristics distribution among study group (n=8).

Baseline characteristics	Total (n=8)
Gender
Female	4 (50.0%)
Male	4 (50.0%)
Age (years)
Range	8-12
[Mean ± SD]	10.88±1.36

EDO promoted a statistically significant (p<0.05) increases of Maxillary width in molar and premolar region with the mean difference 1.73mm and 3.08mm respectively which show greater expansion in premolar region than inter molar region. EDO demonstrated similar changes in Nasal cavity width in molar and premolar region with the mean difference 1.75 mm (p<0.05). Greater increase in Alveolar crest width and Arch width in molar region the mean difference 4.79 mm 4.35mm respectively (p<0.05) (Table 2).

As the EDO is tooth-borne expander there was effect on the dentoalveolar apparatus there was a statistically significant increase (P<0.05) of approximately 0.5 mm, in bone dehiscence, Alveolar crest level, after treatment. The thickness of the buccal bone plate showed a statistically significant decrease mean difference -0.57mm with significant increase in the thickness Palatal alveolar bone mean difference 1.33 mm both were measured on the permanent first molar anchor tooth at the level of CEJ. And there was a statistically significant increase in buccal molar inclination mean difference 2.25°- 6.36°(Table 2).

Table 2 Intergroup comparisons of the expansion changes (Paired Sample t-test)

	Pre-Treatment	Post-Treatment	Paired Sample t-test
	Pre-Treatment	Post-Treatment	MD±SE	t-test	p-value
Molar region
Coronal
Maxillary width (MxW)(mm)	60.20±4.24	61.93±3.93	1.73±0.56	3.093	0.017*
Alveolar crest width (ACW)(mm)	33.01±3.18	37.80±3.22	4.79±0.66	7.257	<0.001**
Arch width (AW)(mm)	41.11±4.37	45.46±4.16	4.35±0.72	6.018	<0.001**
Nasal cavity width (NCW)(mm)	28.53±2.76	30.28±2.53	1.75±0.46	3.812	0.007*
Tooth inclination URPFM (degree)	111.08±6.07	113.33±5.00	2.25±0.68	3.308	0.013*
Tooth inclination ULPFM (degree)	109.40±6.98	115.76±3.50	6.36±2.08	3.058	0.018*
Alveolar crest level URPFM(ACL) (mm)	7.08±1.05	7.58±1.21	0.50±0.40	1.250	0.251
Alveolar crest level ULPFM (ACL) (mm)	7.28±1.19	7.76±1.18	0.49±0.19	2.536	0.039*
Axial
Buccal alveolar bone thickness URPFM at CEJ (mm) BABT	1.82±0.43	1.25±0.72	-0.57±0.13	4.309	0.004*
Palatal alveolar bone thickness URPFM (mm) PABT	3.71±0.69	5.04±0.65	1.33±0.27	5.011	0.002*
Buccal alveolar bone thickness ULPFM at CEJ (mm)	1.47±0.71	1.06±0.68	0.41±0.20	2.046	0.080
Palatal alveolar bone thickness ULPFM at CEJ (mm)	3.39±0.94	4.55±1.17	1.16±0.27	4.383	0.003*
Maxillary alveolar width posterior (MAWP) (MM)	37.06±3.18	41.18±2.62	4.11±0.46	9.017	<0.001**
Premolar region
Coronal
Nasal cavity width (NCW)(mm)	26.99±2.40	28.74±2.47	1.75±0.70	2.499	0.041*
Maxillary width (MxW)(mm)	41.23±6.17	44.30±5.30	3.08±0.41	7.413	<0.001**
Axial
Maxillary alveolar width anterior (MAWA) (mm)	26.60±2.87	30.78±4.01	4.18±0.59	7.054	<0.001**
URPFM: upper right permanent first molar, ULPFMP: upper left permanent first molar, CEJ: cementoenamel junction
p-value >0.05 is insignificant; p<0.05 is significant; *p-value <0.001 is highly significant

There was a statistically significant smaller increase in anterior alveolar width (AWA) 4.18 mm than posterior alveolar width (AWP) 4.11mm. For changes in cephalometric reading in sagittal direction, in maxilla a significant difference (P < .05) was seen in following parameters; SNA with a mean increase of 0.76°, ANB with a mean increase of 2.10°. In mandible, a significant difference (P < .05) SNB with a mean reduction of -1.35°(Table 3).

There was no significant correlation between posterior and anterior according to maxillary width (mm), nasal cavity width and maxillary alveolar width posterior in pre-treatment and post treatment (p-value >0.05) (Table 3).

Table 3 Intergroup comparisons of protraction changes ( Paired Sample t-test)

	Pre-Treatment	Post-Treatment	Paired Sample t-test
	Pre-Treatment	Post-Treatment	MD±SE	t-test	p-value
SNA (degree)	78.33±4.53	79.11±4.43	0.79±0.25	3.137	0.016*
SNB (degree)	75.54±4.50	74.19±4.26	-1.35±0.51	2.624	0.034*
ANB (degree)	2.79±2.48	4.89±2.85	2.10±0.44	4.743	0.002*
p-value >0.05 is insignificant; p<0.05 is significant; *p-value <0.001 is highly significant

Table 4 Correlation among the following variable using Pearson Correlation Coefficient

Correlated outcome	Person correlation (r-value)	p-value
Before treatment
Anterior and posterior nasal cavity width	0.693	0.057
Anterior and post Maxillary width	0.404	0.321
Anterior and posterior Maxillary alveolar width	0.605	0.112
After treatment
Anterior and posterior nasal cavity width	0.642	0.086
Anterior and post Maxillary width	0.665	0.072
Anterior and posterior Maxillary alveolar width	0.153	0.718
p-value >0.05 is insignificant; p<0.05 is significant; *p-value <0.001 is highly significant

In this study EDO appliance was used to promotes differential expansions in the anterior and posterior regions of the maxillary arch. The need for differential expansions is justified because when using conventional RME expanders in patients with CLP, there is the risk of overexpanding the intermolar distance to correct the extreme constriction in the intercanine distance [8].

Over the past few years many investigators have reported different studies to compere the effect of EDO with conventional expander hyrax and fan shaped.

For cleft patients Garib compared EDO and hyrax using RME the rate of expansion was 0.8 mm per day for one week. The EDO promoted significantly greater increases in the nasal cavity width (1.99 mm) maxillary width (1.31mm), alveolar crest width (4.79mm) and arch width (5.91mm) at the molar region and increase of intercanine width (difference, 3.63 mm) and smaller increases in canine buccal tipping than the conventional hyrax expander [10].

A different protocol was used in this study. Seven weeks of expansion and constriction ALT-RAMEC with a protocol of 1 mm per day. This study demonstrated significant increases in nasal cavity width (1.75mm), maxillary width (1.73mm), alveolar crest width (4.79mm) and arch width (4.35mm) at the molar region.

The mean of maxillary width at premolar region is (3.08mm) in our study this was bigger than maxillary width (1.44mm) in the study of Garib.

For non-cleft patient, de Medeiros Alves introduced randomized clinical trial comparing the Hyrax expander and the EDO using dental models and occlusal radiographs showed that the EDO promoted greater split of the anterior region of the midpalatal suture and greater increase of the intercanine distance than the Hyrax expander [9].

Camila Massaro & Daniela Garib reposted two study that compare the EDO and the FE one study using digital dental models and the other using CBCT showed distinct maxillary arch width and shape changes after RME. The EDO showed greater dentoalveolar expansion in the molar region, while the FE produced greater intercanine distance increase [11,12].

Since the expander used in the study is a tooth-borne appliance, it is mandatory that the effect of Alt-RAMEC on the dentoalveolar apparatus should be taken in consideration especially those surrounding the anchor teeth.

The effect of tooth and tissue-borne expanders under the Alt-RAMEC protocol on buccal and palatal alveolar bone has been studied for cleft and non-cleft patient. Gandedkar and Liou published a study for non-cleft patient on changes in BABT and PABT in patients undergoing Alt-RAMEC protocol in 4 transverse sections where they found a significant reduction in the BABT in the cervical region, and an increase in the PABT of the anchor teeth [19]. Also, Singh reported the same result for cleft patient after completion of Alt-RAMEC and protraction by face mask which the measurement was taken at three transverse sections. Similarly, in this study, there was reduction in BABT (mean difference: -0.57±0.13) and increase in PABT (mean difference: 1.33±0.27) [20].

Face mask appliance is the most popular appliance to move maxilla forward. Many investigators used RME before face mask treatment to disarticulate the circummaxillary sutures and facilitate maxillary protraction. Few reviews in literature used Alt-RAMEC protocol with face mask maxillary protraction ⁽¹⁸⁾. For cleft patients, Liou and Tsai reported greater maxillary forward movement in the Alt-RAMEC group (5.8 mm) [16]. Yen [21] introduced a modification of the techniques introduced by Liou and Tsai: a combination of Alt-RAMEC, Class III elastics, and facemask protraction. Good clinical outcomes were observed in his study on adolescent patients with cleft lip and palate. However, da Luz Vieira et al [22] found no significant difference in the maxillary sagittal movement after facemask treatment with ALT-RAMEC or RPE in cleft patients.

In this study demonstrated significant differences in maxillary forward movement (SNA mean difference 0.79±0.25)

Alveolar crest bone level after expansion has been reported in many studies. Studies which used hyrax expander conceded alveolar bone loss which ranges from 0.65 mm to 4.6 mm in the first molar region[23,24,25]. In this study, A decrease of the alveolar crest level was observed the mean was 0.5 mm which is similar to those used hyrax.

The EDO with Alt-RAMEC protocol promoted a significant buccal inclination of the maxillary permanent first molars with a mean increase of 6.36 degrees (Table 2). These results are in accordance to previous studies in individuals with and without oral clefts [4, 26]. The lateral rotation of the maxillary segments, which is accompanied by a greater lateral displacement of the anchorage tooth crown than the movement of the tooth apex, causes the posterior teeth's buccal inclination [27].

The comparison between the anterior and posterior regions showed no significant differences between maxillary width, nasal cavity width and alveolar width in pre-treatment and post treatment p-value >0.05. However, there was virtually smaller increase in the MxW and AWA(Table2,4). A prospective clinical trial study suggested also no significant differences between posterior and anterior region when used EDO [10].

The results showing greater expansion in anterior and posterior region and forward movement of maxilla after using EDO with ALT-RAMEC protocol and facemask in cleft lip and palate patient. The EDO may use as alternative to conventional expanders when a greater amount of expansion is required in the maxillary dental arch anterior region.

The EDO showed greater expansion at the anterior region than posterior region.
Alternate rapid maxillary expansion and constriction can effectively protract the maxilla when used with EDO.
A greater frequency of anterior crossbite correction was observed in study group.
A decrease in the height and thickness of the buccal bone plate is expected given the effects of Alt-RMEC on the supporting tissues of patients with clefts

Author Contribution

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Sarah S Khalil and Maha M. Mohammad. The first draft of the manuscript was written by Sarah S Khalil. Ahmed E Salama and Maiada M Awad contributed to revising the manuscript for language and content and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Ethics Approval and Consent to Participate

Ethical approval was obtained by the Research Ethical Committee at Faculty of Dental Medicine for Girls, Al-Azhar University in Cairo, Egypt (protocol number: ORTHO-109-2-F / P-OR-20-5).The objectives of the study were discussed with the parents and written informed consent form was signed from the participants’ parents or legal guardians before intervention the orthodontic treatment.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Conflict of Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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No competing interests reported.

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Evaluation of The Treatment Outcome of Cleft Palate Patients Treated with Differential Opening Expander with Alt-RAMEC Protocol and Facemask : (a cohort clinical study )

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