Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults

Study Overview
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Brief Summary
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OBJECTIVE: To evaluate the effects of different time intervals activations on the non-surgical maxillary expansion in adults. Methods: This study will include two groups, 10 adult patients each (mean age 20-35) with maxillary transverse deficiency and unilateral or bilateral crossbite. In the first group, the expansion is going to be activated every four days. In the second group, activation will occur every eight days. The primary outcomes are transverse dimension, the buccal cortical bone formation, and the upper premolar and molar labial inclination. Dentoalveolar changes will be evaluated using CBCT images and digital models.

Official Title
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Activation Intervals Effects on Non-surgical Semi-rapid Maxillary Expansion in Adults

Conditions
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Maxillary Anomaly

Intervention / Treatment
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* Procedure: semirapid maxillary expansion (SRME)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Presence of transverse maxillary deficiency unilateral or bilateral in which the maxillary cusps of at least two premolars and/or maxillary molars occluded on the central fossa of the antagonist's teeth The needs of maxillary expansion for the correction of their malocclusion Age range from 20 to 35 Non-gingivitis or untreated caries at the start of orthodontic treatment Probing depth less than 4mm across the entire dentition Gingival index ≤ 1 Plaque index ≤ 1 Exclusion Criteria: Increased Monson curve Patients with systemic disease Patients with congenital anomalies Medicated patients (long term use of antibiotics, Phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers) Pregnancy Poor oral hygiene for more than two visits Radiographic evidence of moderate to severe bone loss Current periodontal disease Patients who smoke Individuals with inadequately treated endodontic problems in the study area.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Every week RPE activation<br>Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every week until getting the require expansion needed | Procedure: semirapid maxillary expansion (SRME)<br>* A Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension<br>* Other names: Maxillary Expansion;|
| Active Comparator: Every four days RPE activation<br>Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every four days until getting the require expansion needed | Procedure: semirapid maxillary expansion (SRME)<br>* A Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension<br>* Other names: Maxillary Expansion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transversal distance between upper canines, first premolars and upper first molars | Distance between mesial fosa of each upper canines, first premolars and distance between central fosa of each upper first molars | Change from baseline to 6 months | 
| Posterior teeth buccal inclination | Measure in CBCT in a coronal slice between the palatal plane and the dental axis | Change from baseline to 6 months | 
| Buccal bone area evaluation | Measure in CBCT in a coronal slice, thickness of the buccal bone in upper first premolars and upper first molars | Change from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing (BP) | It's going to be measured by clinical exam with a periodontal probe and it is verified the presence of bleeding and it will be register as 0= No bleeding and 1= bleeding | Change from baseline to 6 months | 
| Evaluation of the perception of pain by the patient (VAS) | Pain visual analogue scale (AVS) - from 0 to 10 points, Higher values represent more pain perception by the participant | Change from baseline to 6 months | 
| Probing depth (PD) | Probing depth (PD): It's going to be measured by clinical exam with a periodontal probe and it is measured from the gingival margin to the bottom of the groove. It is considered the presence of a periodontal pocket when the depth of the groove is greater than 3mm. | Change from baseline to 6 months | 
| Clinical attachment level (CAL) | Linear measurement in mm. It is constructed from the relationship between probe depth (PD) and the measurement in millimeters from the cement enamel junction (CEJ) to the gingival margin | Change from baseline to 6 months | 
| Soft tissue recession (STR) | Soft tissue apical migration of the cement-enamel junction, it is going to classified as: Class I: Retraction of marginal tissue that does not extend to the mucogingival junction without loss of interdental tissue. Class II: Retraction of marginal tissue that extends to the mucogingival junction, or beyond it, there is no loss of bone, nor of interdental soft tissue. | Change from baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palatal Expansion Technique, Cone-Beam Computed Tomography