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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Every week RPE activation | Active Comparator | Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every week until getting the require expansion needed |
|
| Every four days RPE activation | Active Comparator | Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every four days until getting the require expansion needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semirapid maxillary expansion (SRME) | Procedure | A Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension |
|
| 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 |
| 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) |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonia Plaza, MSD | Contact | 573183973032 | orthoplaza@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Elsa Arango, DDS | Fundación Universitaria UniCIEO | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Universitaria UniCIEO | Recruiting | Bogotá | DC | 110111 | Colombia |
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| ID | Term |
|---|---|
| D010155 | Palatal Expansion Technique |
| ID | Term |
|---|---|
| D009971 | Orthodontics, Corrective |
| D009970 | Orthodontics |
| D003813 | Dentistry |
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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 |