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Early Crossbite Correction - a Randomized Study

Primary Purpose

Malocclusion, Crossbite

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Early crossbite correction with Q-H Device
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Early Orthodontic treatment, Orthodontic treatment outcome, Crossbite treatment

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of OuluRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early crossbite correction

Crossbite correction in mixed dentition

Arm Description

Early crossbite correction with Q-H Device

Later crossbite correction, during mixed dentition

Outcomes

Primary Outcome Measures

Normal occlusion, no lateral crossbite, normal measured Overjet and Overbite
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

Patient compliance, questionnaire
Eariler tested questionnaire is used to compare compliance a different treatment ages
Stability of occlusion in long-term follow-ups.
Normal occlusion, no lateral crossbite, Normal measured Overbite and Overjet in mm Overbite 1 mm to 4 mm Overjet 1mm to 4 mm

Full Information

First Posted
August 8, 2016
Last Updated
November 22, 2017
Sponsor
University of Oulu
Collaborators
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03353766
Brief Title
Early Crossbite Correction - a Randomized Study
Official Title
The Effect of Timing on Lateral Crossbite Correction - a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Recruiting
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
Collaborators
Oulu University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 aim was further to find out the possible benefits and the burden of early treatment to the patients and parents of these common malocclusions, when compared to groups treated later, but with the same methods as much as possible. 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. Background. In spite of the fact that about 30 to 50% of the children in Europe undergo orthodontic treatment during growth, negligible amount of RCT based data is available concerning these treatments. The most used treatment method in Finland, and one of the most popular in the world, is to treat lateral malocclusion with the maxillary dental arch expanding Quad-Helix appliance (Bodoy et al., 2011; Petren et al., 2011; Lippold et al., 2013). The goal of the expansion treatment is typically described as to expand maxillary dental arch, expand the maxilla and correct the possible functional shift in the occlusion. The views of the effects of the expanding devices during early childhood are to some extent inconclusive, at least when the long-term effects are concerned. Most reports that are based on a short-term follow-up, describing maxillary arch expansion and the correction of the crossbite. When the Quad-Helix appliance is compared to the removable appliance, the Q-H is found to be more effective (Petren et al., 2011). When it comes to the elimination of the functional lateral shift after the crossbite treatment, the research data is weak and not sufficient (Tsanidis et al., 2016). Valid evidence based data is rare and the thus exact conclusions are very difficult to be set. Preliminary Studies. The investigators conducted a randomized clinical study with an expanding Headgear device, where the control group was treated with a camouflage treatment, without expansion in the adolescence. The main difference between the groups was broader dental arch with less extractions in the headgear group, the differences between the groups being relatively small, except the broader dental arch in the Headgear group. (Mäntysaari et al.,2004; Pirttiniemi et al.,2005; Krusinskiene et al., 2008). However, canine eruption pattern was found to be more favorable in the early headgear group (Silvola et al., 2008). Experimental Design and Methods 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 inclusion criteria are crossbite of at least two deciduous lateral teeth. Exclusion criteria are anterior crossbite, missing permanent teeth, or craniofacial anomaly. The subjects 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 behavioral pattern (Rutter et al., 2001). In both studies, all the guidelines of RCT are applied (Moher and Schulz, 2005). 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. Quality assurance plan. Quality of the data collected is secured by preliminary training that has been done concerning the input data and the registration processes. The collected data is monitored on regular basis, on clinical records this is done by three months intervals. The quality assurance of the clinical data is done by the same person who has trained the dental personnel by on-site monitoring and auditing. Immediate feed-back is given to the registering personnel concerning the quality of the records. The input data is monitored by testing the normality of the data during the input process. Immediate feed-back is given to the personnel doing the registration process in the cases of deviation is found in the range of normality or consistence of the data. Basic assumption is that the input data is supposed to be normally distributed with this type of patient material. Intra- and Inter-examiner error is tested during the measuring process to test the accuracy of the measurements. The level of error is compared to the level of level reached in corresponding studies. Sample size assessment Power and sample size calculation has been made using the data derived from the preliminary studies (Mäntysaari et al., 2004), and the applied sample size was gained using the formula for the purpose:(http://stat.ubc.ca/~rollin/stats/ssize/n2.html). The used estimates for means and deviations were gained from the analogous preliminary study. The test power used in the power analysis was 0.80 with the level of significance p=0.05. The used value give the sample size 49, and thus the used sample is very sufficient. Plan for missing data. It is known from earlier longitudinal orthodontic studies that the drop-out rate is about 20% when reaching the end point of the study. This has been taken into account in the original sample size. As randomization is applied, it is likely that the missing subjects will occur approximately at the same rate in both study groups and by choosing appropriate statistical methods, the data can be handled. Statistical analysis plan. The study hypothesis is tested by using statistical methods. When the differences between the two groups are tested, a test for two independent samples is utilized. When the values of the children are compared at different time points, a test of related samples is used. If the sample data is not normally distributed, a non-parametric test is applied ( e.g. Mann-Whitney-test or Wilcoxon-test). When the behavioral items are tested, the applied tests are on ordinary level or nominal level (e.g. Cross-tabulation tests). To estimate the Intra-examiner and Inter-examiner error, double measurements are performed. The statistical testing of the error is done using Intra class correlation (ICC). The Intention to treat principle is applied in the study. The results will be shown both in graphical and table format to clearly show group and individual variation. The statistical testing is done by using the latest version of SPSS program. Timing and Importance of the studies The first part of the study will be initiated in 2016. The study will continue actively during the years 2016-2019. The treatments and the follow-up continues until the growth is over, until about year 2028, and further until the adulthood. Most of the data, however, is available to be analyzed already earlier in 2018-2020. The results of these studies are clinically very important and therefore they will be published in the most respected international orthodontic journals. As the results are of the highest clinical relevance with a sound evidence, they can easily be applied directly to clinical practices. University of Oulu will give all the facilities needed for the research, including rooms. The clinical examinations are performed in the health centers as a part of normal treatment costs, when normal documentation is concerned.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Crossbite
Keywords
Early Orthodontic treatment, Orthodontic treatment outcome, Crossbite treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early crossbite correction
Arm Type
Experimental
Arm Description
Early crossbite correction with Q-H Device
Arm Title
Crossbite correction in mixed dentition
Arm Type
No Intervention
Arm Description
Later crossbite correction, during mixed dentition
Intervention Type
Device
Intervention Name(s)
Early crossbite correction with Q-H Device
Other Intervention Name(s)
Expanding device, Maxillary expansion
Intervention Description
Crossbite treatment in deciduous dentition with Quad-Helix appliance
Primary Outcome Measure Information:
Title
Normal occlusion, no lateral crossbite, normal measured Overjet and Overbite
Description
Normal occlusion is measured as: harmonous occlusal contacts, no lateral crossbite Overbite 1 mm to 4 mm Overjet 1mm to 4 mm
Time Frame
13 years
Secondary Outcome Measure Information:
Title
Patient compliance, questionnaire
Description
Eariler tested questionnaire is used to compare compliance a different treatment ages
Time Frame
6 years
Title
Stability of occlusion in long-term follow-ups.
Description
Normal occlusion, no lateral crossbite, Normal measured Overbite and Overjet in mm Overbite 1 mm to 4 mm Overjet 1mm to 4 mm
Time Frame
13 years
Other Pre-specified Outcome Measures:
Title
Measured degree of facial asymmetries
Description
Facial asymmetry measured on 3D photographs in lower facial area in% Facial asymmetry measured on 3D phptpgraphs in middle facial area in%
Time Frame
13 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pertti M. Pirttiniemi, Professor
Phone
+358405224199
Email
pertti.pirttiniemi@oulu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna-Sofia Silvola, Dr.
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oulu
City
Oulu
ZIP/Postal Code
90450
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pertti M Pirttiniemi, Professor
Phone
+358405224199
Email
pertti.pirttiniemi@oulu.fi

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At the moment there is no such plan
Citations:
PubMed Identifier
18632838
Citation
Krusinskiene V, Kiuttu P, Julku J, Silvola AS, Kantomaa T, Pirttiniemi P. A randomized controlled study of early headgear treatment on occlusal stability--a 13 year follow-up. Eur J Orthod. 2008 Aug;30(4):418-24. doi: 10.1093/ejo/cjn021. Epub 2008 Jul 16.
Results Reference
background
PubMed Identifier
23339736
Citation
Lippold C, Stamm T, Meyer U, Vegh A, Moiseenko T, Danesh G. Early treatment of posterior crossbite--a randomised clinical trial. Trials. 2013 Jan 22;14:20. doi: 10.1186/1745-6215-14-20.
Results Reference
background
PubMed Identifier
14994883
Citation
Mantysaari R, Kantomaa T, Pirttiniemi P, Pykalainen A. The effects of early headgear treatment on dental arches and craniofacial morphology: a report of a 2 year randomized study. Eur J Orthod. 2004 Feb;26(1):59-64. doi: 10.1093/ejo/26.1.59.
Results Reference
background
PubMed Identifier
21195260
Citation
Petren S, Bjerklin K, Bondemark L. Stability of unilateral posterior crossbite correction in the mixed dentition: a randomized clinical trial with a 3-year follow-up. Am J Orthod Dentofacial Orthop. 2011 Jan;139(1):e73-81. doi: 10.1016/j.ajodo.2010.06.018.
Results Reference
background
PubMed Identifier
15961567
Citation
Pirttiniemi P, Kantomaa T, Mantysaari R, Pykalainen A, Krusinskiene V, Laitala T, Karikko J. The effects of early headgear treatment on dental arches and craniofacial morphology: an 8 year report of a randomized study. Eur J Orthod. 2005 Oct;27(5):429-36. doi: 10.1093/ejo/cji025. Epub 2005 Jun 16.
Results Reference
background
PubMed Identifier
19413375
Citation
Silvola AS, Arvonen P, Julku J, Lahdesmaki R, Kantomaa T, Pirttiniemi P. Early headgear effects on the eruption pattern of the maxillary canines. Angle Orthod. 2009 May;79(3):540-5. doi: 10.2319/021108-83.1.
Results Reference
background
PubMed Identifier
26257271
Citation
Tsanidis N, Antonarakis GS, Kiliaridis S. Functional changes after early treatment of unilateral posterior cross-bite associated with mandibular shift: a systematic review. J Oral Rehabil. 2016 Jan;43(1):59-68. doi: 10.1111/joor.12335. Epub 2015 Aug 8.
Results Reference
background
PubMed Identifier
21195256
Citation
Godoy F, Godoy-Bezerra J, Rosenblatt A. Treatment of posterior crossbite comparing 2 appliances: a community-based trial. Am J Orthod Dentofacial Orthop. 2011 Jan;139(1):e45-52. doi: 10.1016/j.ajodo.2010.06.017.
Results Reference
result

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Early Crossbite Correction - a Randomized Study

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