NCT03258411

Brief Summary

Evaluating and comparing the short term effects of different palatal expanders on the amount of palatal expansion and buccal tipping of posterior teeth. Hypothesis: H0: There is no difference in the short term effects between the different palatal expanders. H1: There is a significant difference in the short term effects between the different palatal expanders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

4 years

First QC Date

July 22, 2017

Last Update Submit

April 5, 2020

Conditions

Cross Bite

Outcome Measures

Primary Outcomes (2)

  • Amount of skeletal and dental expansion

    These are linear measurements which will be measured in millimetres in the first and the second cone beam computed tomography images and the difference will be calculated.

    3 months

  • Amount of dental inclination

    These are angular measurements which will be measured in degrees in the first and the second cone beam computed tomography images and the difference will be calculated.

    3 months

Study Arms (3)

Haas group (H)

ACTIVE COMPARATOR

Rapid Expansion of palatal suture device: tooth-tissue supported expander (Haas (H)).

Device: Rapid Expansion of palatal suture

Hyrax (Hx)

ACTIVE COMPARATOR

Rapid Expansion of palatal suture device: tooth anchored expander (Hyrax (Hx)).

Device: Rapid Expansion of palatal suture

Miniscrew-supported (MHx)

ACTIVE COMPARATOR

Rapid Expansion of palatal suture device: bone anchored expander (Temporary anchorage devices(miniscrew)-supported (MHx))

Device: Rapid Expansion of palatal suture

Interventions

Rapid Expansion of palatal sutureDEVICE
Haas group (H)Hyrax (Hx)Miniscrew-supported (MHx)

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Non-syndromic adolescent patients.
  • Patients in need for palatal expansion treatment.
  • Average face height.
  • No previous orthodontic treatment.

You may not qualify if:

  • Syndromic adolescent patients.
  • Patients not in need for palatal expansion treatment.
  • Non-average face height.
  • Previous orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz University, Faculty of Dentistry

Jeddah, Mecca Region, 21589, Saudi Arabia

Location

Related Publications (2)

  • Mosleh MI, Kaddah MA, Abd ElSayed FA, ElSayed HS. Comparison of transverse changes during maxillary expansion with 4-point bone-borne and tooth-borne maxillary expanders. Am J Orthod Dentofacial Orthop. 2015 Oct;148(4):599-607. doi: 10.1016/j.ajodo.2015.04.040.

    PMID: 26432315BACKGROUND

  • Lagravere MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):304.e1-12; discussion 304-5. doi: 10.1016/j.ajodo.2009.09.016.

    PMID: 20197161BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master degree student

Study Record Dates

First Submitted

July 22, 2017

First Posted

August 23, 2017

Study Start

February 10, 2015

Primary Completion

February 5, 2019

Study Completion

April 1, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

SA(1)