- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03846518
Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion
March 4, 2020 updated by: Dauro Douglas Oliveira, Pontifícia Universidade Católica de Minas Gerais
Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion: Dentoalveolar Effects and Impact on Quality of Life
This study will assess the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in orthodontic patients with permanent dentition, from 12 to 16 years old.
Half of participants will be treated using the Hyrax expander, while the other half will use the mini Hyrax expander.
The null hypothesis is that there is no difference between dentoalveolar effects and impact on quality of life of the two protocols.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Transverse maxilla deficiency is characterized by narrowing of the maxillary arch with important functional and esthetic impact.
In individuals which have not reached bone maturity, a rapid expansion of the maxilla by using tooth-borne expanders as Haas and Hyrax appliance are efficient and safe.
A presentation of favorable results for the "mini-Hyrax inverted" expander with a small screw in the transversal correction of the maxilla in patients with cleft lip and palate, besides improving the comfort and the teeth cleaning, provoked an idea of application of this small screw to correct posterior crossbite in individuals without cleft lip and palate.
The objective of this study is to compare the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in adolescent patients with permanent dentition and active bone growth.
The sample size calculation indicated a total sample of 28 individuals.
Taking into account the loss of sample during the study, 34 subjects that have posterior crossbite and age from 12 to 16 years, will be recruited at the Dental School, Pontifical University Catholic of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.
These patients will be randomly divided into two groups, Hyrax and mini Hyrax, with 17 patients each.
Digital models of both dental arches will be obtained by intraoral scanning precede the procedure (T0) and at the end of the retention period, after appliance removal (T2).
OHIP-14 Oral Health Impact Profile Questionnaires, validated in Portuguese, will be applied before expansion (T0), after an expansion (T1) and at the end of the retention period (T2).
In digital dental models, maxillary first and second bicuspids and first molar width, and rotation and inclination of maxillary first bicuspids and first molars will be assessed.
After the normality test, the appropriate statistical test will be used in the intergroup comparison.
A significance level of 5% will be regarded for all tests.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 30.535-901
- Pontifícia Universidade Católica de Minas Gerais
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 16 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Maxillary permanent dentition, except canines
- Ages ranging from 12 to 16 years old;
- Maxillary constriction associated to posterior crossbite uni or bilateral.
Exclusion Criteria:
- Cleft lip and palate;
- Craniofacial syndromes;
- Carious lesions;
- History of previous orthodontic treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Hyrax group
Seventeen patients will be submitted to rapid maxillary expansion (RME) using the Hyrax expander.
The activation protocol will be 2 turns a day up to obtain transverse overcorrection.
|
Rapid maxillary expansion using the Hyrax expander.
Appliance anchorage will be performed by bands adapted to the first maxillary molars and arms of the screw contoured to adapt to palatal faces of the first and second maxillary bicuspids, in wich will be bonded by resin.
The screw will be positioned perpendicularly to the palate sagittal midline, between second maxillary bicuspids and first maxillary molars, and 5 mm apically from marginal gingiva of palatal face of the first maxillary molars.The activation protocol will be 2 turns a day up to obtain transverse overcorrection.
After the active period of RME, the screws will be fixed with ligature wire and the appliance will be kept as a retainer for 6 months.
|
EXPERIMENTAL: mini Hyrax group
Seventeen patients will be submitted to rapid maxillary expansion (RME) using the mini Hyrax expander.
The activation protocol will be 2 turns a day up to obtain transverse overcorrection.
|
Rapid maxillary expansion using the mini Hyrax expander.
Appliance anchorage will be performed by bands adapted to the first maxillary molars and arms of the screw contoured to adapt to palatal faces of the first and second maxillary bicuspids, in wich will be bonded by resin.
The screw will be positioned perpendicularly to the palate sagittal midline, between second maxillary bicuspids and first maxillary molars, and 5 mm apically from marginal gingiva of palatal face of the first maxillary molars.
The activation protocol will be 2 turns a day up to obtain transverse overcorrection.
After the active period of RME, the screws will be fixed with ligature wire and the appliance will be kept as a retainer for 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maxillary first molars width. Scale in millimeters and one decimal place.
Time Frame: 6 months
|
Distance between centroid points of maxillary first molars
|
6 months
|
Maxillary first bicuspid width. Scale in millimeters and one decimal place.
Time Frame: 6 months
|
Distance between centroid points of maxillary first bicuspids
|
6 months
|
Maxillary second bicuspid width. Scale in millimeters and one decimal place.
Time Frame: 6 months
|
Distance between centroid points of maxillary second bicuspids
|
6 months
|
Maxillary first molas angulation. Scale in degrees and one decimal place.
Time Frame: 6 months
|
Angulation formed, in occlusal view, by intersection of the lines resulted of the link between mesial-buccal cuspid tip and mesial-palatal cuspid tip of each molar.
|
6 months
|
Maxillary first bicuspids angulation. Scale in degrees and one decimal place.
Time Frame: 6 months
|
Angulation formed, in occlusal view, by intersection of the lines resulted of the link between buccal cuspid tip and palatal cuspid tip of each bicuspid
|
6 months
|
Maxillary first molas inclination. Scale in degrees and one decimal place.
Time Frame: 6 months
|
Angulation formed, in coronal view, by intersection of the lines resulted of the link between mesial-buccal cuspid tip and mesial-palatal cuspid tip of each molar
|
6 months
|
Maxillary first bicuspids inclination. Scale in degrees and one decimal place.
Time Frame: 6 months
|
Angulation formed, in coronal view, by intersection of the lines resulted of the link between buccal cuspid tip and palatal cuspid tip of each bicuspid
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life evaluation using questionnaires
Time Frame: 2 weeks (2 times: 0 and 2 weeks after insert of device) and 6 months (after removal of device)
|
Oral Health Impact Profile (OHIP-14) will be used to evaluate the quality of life of the patients before, during and after treatment.
Fourteen items that explore seven dimensions of impact: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap.
The responses will be classified using the Likert scale with five options ranging from "never" (0) to "very often" (4).
Higher values represent higher levels of impact on each dimension.
|
2 weeks (2 times: 0 and 2 weeks after insert of device) and 6 months (after removal of device)
|
Discomfort evaluation using questionnaires
Time Frame: 24 hours (4 times: 0, 24, 48 and 72 hours after insert of device) and 1 week (2 times: 1 and 2 weeks after insert of device)
|
A Visual Analog Scale will be used from 0 to 100.
Scale in millimeters and one decimal place.
Higher values represent higher level of pain.
The 0 point represents absence of pain and the 100 point represents the maximum pain that patient imagines is possible exist.
|
24 hours (4 times: 0, 24, 48 and 72 hours after insert of device) and 1 week (2 times: 1 and 2 weeks after insert of device)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Dauro D Oliveira, PhD, Associate professor and program director of Orthodontics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2018
Primary Completion (ACTUAL)
September 18, 2019
Study Completion (ACTUAL)
February 27, 2020
Study Registration Dates
First Submitted
February 17, 2019
First Submitted That Met QC Criteria
February 17, 2019
First Posted (ACTUAL)
February 19, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 5, 2020
Last Update Submitted That Met QC Criteria
March 4, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- hyraxversusminihyrax
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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