search
Back to results

Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion

Primary Purpose

Malocclusion, Posterior Crossbite

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hyrax
mini Hyrax
Sponsored by
Pontifícia Universidade Católica de Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring palatal expansion technique, adolescent, quality of life

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pontifícia Universidade Católica de Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hyrax group

mini Hyrax group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Maxillary first molars width. Scale in millimeters and one decimal place.
Distance between centroid points of maxillary first molars
Maxillary first bicuspid width. Scale in millimeters and one decimal place.
Distance between centroid points of maxillary first bicuspids
Maxillary second bicuspid width. Scale in millimeters and one decimal place.
Distance between centroid points of maxillary second bicuspids
Maxillary first molas angulation. Scale in degrees and one decimal place.
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.
Maxillary first bicuspids angulation. Scale in degrees and one decimal place.
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
Maxillary first molas inclination. Scale in degrees and one decimal place.
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
Maxillary first bicuspids inclination. Scale in degrees and one decimal place.
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

Secondary Outcome Measures

Quality of life evaluation using questionnaires
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.
Discomfort evaluation using questionnaires
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.

Full Information

First Posted
February 17, 2019
Last Updated
March 4, 2020
Sponsor
Pontifícia Universidade Católica de Minas Gerais
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
search

1. Study Identification

Unique Protocol Identification Number
NCT03846518
Brief Title
Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion
Official Title
Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion: Dentoalveolar Effects and Impact on Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
September 18, 2019 (Actual)
Study Completion Date
February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pontifícia Universidade Católica de Minas Gerais
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Posterior Crossbite
Keywords
palatal expansion technique, adolescent, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups: control group (Hyrax) and experimental group (mini Hyrax)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyrax group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
mini Hyrax group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hyrax
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
mini Hyrax
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maxillary first molars width. Scale in millimeters and one decimal place.
Description
Distance between centroid points of maxillary first molars
Time Frame
6 months
Title
Maxillary first bicuspid width. Scale in millimeters and one decimal place.
Description
Distance between centroid points of maxillary first bicuspids
Time Frame
6 months
Title
Maxillary second bicuspid width. Scale in millimeters and one decimal place.
Description
Distance between centroid points of maxillary second bicuspids
Time Frame
6 months
Title
Maxillary first molas angulation. Scale in degrees and one decimal place.
Description
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.
Time Frame
6 months
Title
Maxillary first bicuspids angulation. Scale in degrees and one decimal place.
Description
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
Time Frame
6 months
Title
Maxillary first molas inclination. Scale in degrees and one decimal place.
Description
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
Time Frame
6 months
Title
Maxillary first bicuspids inclination. Scale in degrees and one decimal place.
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life evaluation using questionnaires
Description
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.
Time Frame
2 weeks (2 times: 0 and 2 weeks after insert of device) and 6 months (after removal of device)
Title
Discomfort evaluation using questionnaires
Description
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.
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)

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Initially the 34 individuals will be separated by sex, thenceforth the randomization to alocation in the groups will be applied. The objetive of it is avoid major difference in sex between the 2 groups.
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dauro D Oliveira, PhD
Organizational Affiliation
Associate professor and program director of Orthodontics
Official's Role
Study Chair
Facility Information:
Facility Name
Pontifícia Universidade Católica de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30.535-901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion

We'll reach out to this number within 24 hrs