NCT04041804

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

1.4 years

First QC Date

February 13, 2019

Last Update Submit

August 31, 2020

Conditions

Maxillary Anomaly

Keywords

Palatal Expansion TechniqueCone-Beam Computed Tomography

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Bleeding on probing (BP)

    Change from baseline to 6 months

  • Evaluation of the perception of pain by the patient (VAS)

    Change from baseline to 6 months

  • Probing depth (PD)

    Change from baseline to 6 months

  • Clinical attachment level (CAL)

    Change from baseline to 6 months

  • Soft tissue recession (STR)

    Change from baseline to 6 months

Study Arms (2)

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

Procedure: semirapid maxillary expansion (SRME)

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

Procedure: semirapid maxillary expansion (SRME)

Interventions

semirapid maxillary expansion (SRME)PROCEDURE

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

Also known as: Maxillary Expansion
Every four days RPE activationEvery week RPE activation

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Universitaria UniCIEO

Bogotá, DC, 110111, Colombia

RECRUITING

MeSH Terms

Interventions

Palatal Expansion Technique

Intervention Hierarchy (Ancestors)

Orthodontics, CorrectiveOrthodonticsDentistry

Study Officials

  • Elsa Arango, DDS

    Fundación Universitaria UniCIEO

    STUDY CHAIR

Central Study Contacts

Sonia Plaza, MSD

CONTACT

573183973032orthoplaza@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Research Orthodontic Department, Principal Investigator.

Study Record Dates

First Submitted

February 13, 2019

First Posted

August 1, 2019

Study Start

February 1, 2021

Primary Completion

July 1, 2022

Study Completion

December 1, 2022

Last Updated

September 2, 2020

Record last verified: 2020-08

Locations

CO(1)