About this trial
The goal of this clinical trial is to compare if it is better to treat severe anterior crowding in the early mixed dentition then later in the permanent dentition in children with anterior crowding of the upper teeth. The main questions this trial aims to answer are:
* If there is a difference in the degree of anterior crowding between the experimental group and the control group after a five year follow-up period. * If there is a difference between the experimental group and the control group in regard to oral health related quality of life. * If there is spontaneous transversal adaption of the lower dental arch to upper dental arch after maxillary expansion and compare this to the control group. * If early maxillary expansion is more cost-effective than treatment in the permanent dentition.
To be eligible for this trial the subject must be children between six and nine years old at the time for inclusion. The children must have crowding of the upper front teeth of six millimeters or more and the lateral incisors should not have erupted or just erupted through the gingiva.
Subjects randomized to the experimental group will get an expansion treatment in the upper jaw with rapid maxillary expansion device to gain enough space for the lateral incisors to erupt. All subjects, also the subjects randomized to the control group, are followed until all permanent teeth have erupted.
At the end of the follow-up period all subjects fill out a questionnaire to evaluate their oral health related quality of life.
Researchers will then compare the subjects in both groups to evaluate if there is a difference in anterior crowding after the follow-up period. Differences in cost-effectiveness, morphological changes and the subjects oral health related quality of life will also be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthy subjects without sucking habits
Permanent maxillary central incisors and first permanent molars fully erupted. DS1M1.
No severe crowding or protrusion in the lower arch considering the Leeway space and normal development of the arch.
Permanent first molar in normal transversal relation.
Disqualifiers
Skeletal asymmetries, anomalies and syndromes.
Previous orthodontic treatment
Trial design
Parallel
Treatments tested in this trial
Maxillary expansion device
DeviceThe maxillary expansion device is a orthodontic appliance that is used to expand the maxilla in children.
Treatment groups
Trial outcomes
Primary outcomes
Long-term spontaneous alignment of anterior maxillary teeth
The long-term spontaneous alignment of anterior maxillary teeth will be evaluated visually and measure on the digital study models.
Secondary outcomes
Impact on oral health related quality of life
The impact of early expansion treatment on the oral health will be measure at the end of the observation period in both the experimental group and the control group. This will be measured with the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ). The PIDAQ is made of four subparts; * Dental Self-Confidence; six questions answered on a Likert-scale between 0 and 4. Maximum score is 24 och minimum is zero. Higher score is better. * Social Impact: eight questions answered on a Likert-scale between 0 and 4. Maximum score is 32 and zero minimum. Lower score is better. * Psychological Impact: six questions answered on a Likert-scale between 0 and 4. Maximum score is 24 and zero minimum. Lower score is better. * Aestethic Concern: three questions answered on a Likert-scale between 0 and 4. Maximum score is twelve and zero minimum. Lower score is better
Cost-effectiveness of early expansion treatment
The total cost of treatments in both the control- and experimental group will be compared to evaluate which treatment is the most cost-effective.
Morphological changes in the upper and lower arches.
The morphological changes after expansion will be measured on study models and compared to the study models at the start point. The same will be conducted on the study models for the control group.
Complications of expansion.
This measure will be reported descriptive and the complications analyzed.
Sponsors and contacts
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