ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Crossbite Correction - a Randomized Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03353766
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
University of Oulu

Brief Summary:

The aim of this longitudinal randomized investigation is to determine the long-term effects of early lateral crossbite correction with Quad-Helix appliance, during the deciduous dentition, on craniofacial structures and dental arches, compared to treatment started later, after the first permanent molars have erupted.

The hypothesis is that the timing of treatment has significant effects on orthodontic treatment total time, the general outcome of the treatment, and the compliance of the patient.

The Age cohort of five-year-old of children living in the community areas of Oulunsalo are screened at the age of 5 years for malocclusions. Of these children 80 children who meet the criteria are chosen for the study after the written consent.

The children are randomized into two groups. In the first group the treatment with Quad-Helix appliance is started at the age of 5 to 6 years, before the eruption of the permanent molars. The device is cemented to the second deciduous molars. The treatment is continued and continued until normal lateral occlusion is achieved and the device is kept stable for one year after this.

In the second group headgear treatment is started after the first permanent maxillary molars have erupted. The device is cemented to the first permanent molars. The treatment is continued until normal lateral occlusion is achieved and the device is kept stable for one year after this.

In both groups dental casts, cephalograms, and standardized 3D facial photographs are taken before treatment (T0), after the first treatment phase (T1), after the second treatment phase (T2) and after the growth (T3).

Facial 3D scanning is performed for all the subjects after the treatment to find out the effect of different treatment methods on facial characteristics. The dental casts are scanned to make 3D models of the cast to be used in detailed analysis.

A wide multi-level questionnaire is performed before, during and after the study to the parents and the children to find out the comprehensive effects of orthodontic treatment on the well-being of the child. The questionnaire includes the Rutter's child behavioural pattern (Rutter et al., 2001).

In both studies, all the guidelines of RCT are applied. Blinding of the clinicians is gained, as the orthodontists or dentists treating the children are not aware of the rationale of the study. Blinding is applied on all measurement of the documents.


Condition or disease Intervention/treatment Phase
Malocclusion Crossbite Device: Early crossbite correction with Q-H Device Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Timing on Lateral Crossbite Correction - a Randomized Study
Study Start Date : April 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
Experimental: Early crossbite correction
Early crossbite correction with Q-H Device
Device: Early crossbite correction with Q-H Device
Crossbite treatment in deciduous dentition with Quad-Helix appliance
Other Name: Expanding device, Maxillary expansion

No Intervention: Crossbite correction in mixed dentition
Later crossbite correction, during mixed dentition



Primary Outcome Measures :
  1. Normal occlusion, no lateral crossbite, normal measured Overjet and Overbite [ Time Frame: 13 years ]

    Normal occlusion is measured as:

    • harmonous occlusal contacts, no lateral crossbite
    • Overbite 1 mm to 4 mm
    • Overjet 1mm to 4 mm


Secondary Outcome Measures :
  1. Patient compliance, questionnaire [ Time Frame: 6 years ]
    Eariler tested questionnaire is used to compare compliance a different treatment ages

  2. Stability of occlusion in long-term follow-ups. [ Time Frame: 13 years ]

    Normal occlusion, no lateral crossbite, Normal measured Overbite and Overjet in mm

    • Overbite 1 mm to 4 mm
    • Overjet 1mm to 4 mm


Other Outcome Measures:
  1. Measured degree of facial asymmetries [ Time Frame: 13 years ]
    • Facial asymmetry measured on 3D photographs in lower facial area in%
    • Facial asymmetry measured on 3D phptpgraphs in middle facial area in%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Crossbite of at least two deciduous lateral teeth
  • Full deciduous dentition
  • Age 5 to 6 years

Exclusion Criteria:

  • Anterior crossbite
  • Missing permanent teeth,
  • Craniofacial syndrome, Cleft lip/palate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353766


Contacts
Contact: Pertti M. Pirttiniemi, Professor +358405224199 pertti.pirttiniemi@oulu.fi

Locations
Finland
University of Oulu Recruiting
Oulu, Finland, 90450
Contact: Pertti M Pirttiniemi, Professor    +358405224199    pertti.pirttiniemi@oulu.fi   
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Investigators
Principal Investigator: Anna-Sofia Silvola, Dr. University of Oulu

Publications of Results:
Other Publications:

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT03353766     History of Changes
Other Study ID Numbers: EETTMK:124/2008
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At the moment there is no such plan

Keywords provided by University of Oulu:
Early Orthodontic treatment
Orthodontic treatment outcome
Crossbite treatment

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases