Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults

NCT ID: NCT04041804

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2022-12-31

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.

Detailed Description

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Conditions

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Maxillary Anomaly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Every week RPE activation

Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every week until getting the require expansion needed

Group Type ACTIVE_COMPARATOR

semirapid maxillary expansion (SRME)

Intervention Type PROCEDURE

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

Every four days RPE activation

Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every four days until getting the require expansion needed

Group Type ACTIVE_COMPARATOR

semirapid maxillary expansion (SRME)

Intervention Type PROCEDURE

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

Interventions

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semirapid maxillary expansion (SRME)

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

Intervention Type PROCEDURE

Other Intervention Names

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Maxillary Expansion

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Universitaria CIEO

OTHER

Sponsor Role lead

Responsible Party

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Sonia Patricia Plaza

Director, Research Orthodontic Department, Principal Investigator.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elsa Arango, DDS

Role: STUDY_CHAIR

Fundación Universitaria UniCIEO

Locations

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Fundación Universitaria UniCIEO

Bogotá, DC, Colombia

Site Status RECRUITING

Countries

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Colombia

Central Contacts

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Sonia Plaza, MSD

Role: CONTACT

573183973032

Facility Contacts

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Sonia P Plaza, Msc

Role: primary

573183973032

Elsa Arango, DDs

Role: backup

573102857936

Other Identifiers

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044

Identifier Type: -

Identifier Source: org_study_id

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