The Effect of Malocclusions on Oral Health Related Quality of Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-19
SponsorMalmö University
About this trial
Malocclusions in adolescents may affect oral health related quality of life. The study aims at;
1. Evaluating two instruments measuring oral health related quality of life; "Child Perceptions Questionnaire 11-14" (CPQ 11-14) short form and "Psychosocial Impact of Dental Aesthetics Questionnaire" (PIDAQ). 2. Comparing differences in oral health related quality of life in;
1. adolescents with different types of malocclusion and without malocclusions 2. individuals of different genders and socioeconomic status 3. Longitudinally evaluating differences in oral health related quality of life;
1. before, during and after orthodontic treatment 2. in untreated individuals (without malocclusion) over time
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adolescents 12-19 years of age with malocclusion (IOTN grade 4 and 5) referred to specialist orthodontic clinics
Adolescents 12-19 years of age without malocclusion (IOTN grad 1, 2 or 3) at general dentistry clinics
Disqualifiers
Previous orthodontic treatment
Cleft lip and palate
ASA ≥ III
Intellectual and/or physical inability to answer questionnaires
Trial population
Malocclusion group 500 12-19 year olds with malocclusion, defined as IOTN-DHC grade 3, 4 or 5. The adolescents are consecutively recruited new patients at three orthodontic centers; Center for Orthodontics and Pediatric Dentistry, Norrköping, Public Dental Service Östergötland; Department of Orthodontics, Folktandvården Stockholms län AB, Folktandvården Eastmaninstitutet, Stockholm, Sweden and Department of Orthodontics, Malmö University, Malmö, Sweden. Patients are examined at the initial examination at the orthodontic department, before any orthodontic treatment is begun. No malocclusion group 175 12-19 year olds without malocclusion, defined as IOTN-DHC grade 1 or 2. Patients are consectively recruited adolescents examined at their general dentistry clinic.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Malocclusion and Orthodontic Treatment
Other interventionGroup 1 is exposed to malocclusion and orthodontic treatment. However, the inclusion in the study does not affect the treatment since it is an observational study. The exposure of group 2 is no malocclusion, no orthodontic treatment.
Treatment groups
675 Participants
are divided into 2 treatment groupsGroup A: Malocclusion group1 intervention
Group B: No malocclusion group0 interventions
Trial outcomes
Primary outcomes
1
Oral Health Related Quality of Life measured with Child Perceptions Questionnaire 11-14 short form- change before and after orthodontic treatment and at matched time points in an untreated population
Child Perceptions Questionnaire (CPQ) 11-14 short form is a common instrument measuring Oral Health Related Quality of life (OHRQoL) in children and adolescents. It is a generic instrument, measuring all aspects of OHRQoL.
Time frame
At start of study, 1 year after start of study, at study completion (an average of 2.5 years), 1 year after study completion2
Oral Health Related Quality of Life measured with Psychosocial Impact of Dental Aesthetics Questionnaire - change before and after orthodontic treatment and at matched time points in an untreated population
Psychosocial Impact of Dental Aesthetics (PIDAQ) is an instrument measuring orthodontic specific aspects of OHRQoL.
Time frame
At start of study, 1 year after start of study, at study completion (an average of 2.5 years), 1 year after study completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Malmö University
Lead sponsor
Region Östergötland
Collaborator
Folktandvården Stockholms län AB
Collaborator
Source ClinicalTrials.gov