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Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04041804
Enrollment
20
Registered
2019-08-01
Start date
2021-02-28
Completion date
2022-12-31
Last updated
2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Anomaly

Keywords

Palatal Expansion Technique, Cone-Beam Computed Tomography

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.

Interventions

PROCEDUREsemirapid maxillary expansion (SRME)

A Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension

Sponsors

Fundación Universitaria CIEO
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Transversal distance between upper canines, first premolars and upper first molarsChange from baseline to 6 monthsDistance between mesial fosa of each upper canines, first premolars and distance between central fosa of each upper first molars
Posterior teeth buccal inclinationChange from baseline to 6 monthsMeasure in CBCT in a coronal slice between the palatal plane and the dental axis
Buccal bone area evaluationChange from baseline to 6 monthsMeasure in CBCT in a coronal slice, thickness of the buccal bone in upper first premolars and upper first molars

Secondary

MeasureTime frameDescription
Clinical attachment level (CAL)Change from baseline to 6 monthsLinear 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
Bleeding on probing (BP)Change from baseline to 6 monthsIt'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
Soft tissue recession (STR)Change from baseline to 6 monthsSoft 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.
Evaluation of the perception of pain by the patient (VAS)Change from baseline to 6 monthsPain visual analogue scale (AVS) - from 0 to 10 points, Higher values represent more pain perception by the participant
Probing depth (PD)Change from baseline to 6 monthsProbing 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.

Countries

Colombia

Contacts

Primary ContactSonia Plaza, MSD
orthoplaza@hotmail.com573183973032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026