Early Crossbite Correction - a Randomized Study
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|ClinicalTrials.gov Identifier: NCT03353766|
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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
- Patient compliance, questionnaire [ Time Frame: 6 years ]Eariler tested questionnaire is used to compare compliance a different treatment ages
- 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
- 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%
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353766
|Contact: Pertti M. Pirttiniemi, Professorfirstname.lastname@example.org|
|University of Oulu||Recruiting|
|Oulu, Finland, 90450|
|Contact: Pertti M Pirttiniemi, Professor +358405224199 email@example.com|
|Principal Investigator:||Anna-Sofia Silvola, Dr.||University of Oulu|