Clinical trial NCT04041804: Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults
Official title: Activation Intervals Effects on Non-surgical Semi-rapid Maxillary Expansion in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Anomaly
Keywords: Palatal Expansion Technique
Cone-Beam Computed Tomography
Lead sponsor: Fundación Universitaria CIEO
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Transversal distance between upper canines, first premolars and upper first molars
timeFrame: Change from baseline to 6 months
measure: Posterior teeth buccal inclination
timeFrame: Change from baseline to 6 months
measure: Buccal bone area evaluation
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Bleeding on probing (BP)
timeFrame: Change from baseline to 6 months
measure: Evaluation of the perception of pain by the patient (VAS)
timeFrame: Change from baseline to 6 months
measure: Probing depth (PD)
timeFrame: Change from baseline to 6 months
measure: Clinical attachment level (CAL)
timeFrame: Change from baseline to 6 months
measure: Soft tissue recession (STR)
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación Universitaria UniCIEO
state: DC
Study officials:
affiliation: Fundación Universitaria UniCIEO
name: Elsa Arango, DDS
role: STUDY_CHAIR
References: