MalocclusionNCT05038865
The Effect of Malocclusions on Oral Health Related Quality of Life
An observational study of Malocclusion and Quality of Life, run by Malmö University at 3 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Quality of Life, Orthodontics
- What is being tested?
- Malocclusion and Orthodontic Treatment
- How many people
- 675 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Dec 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study 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.
Who may be able to join
- 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
Who cannot join
- Previous orthodontic treatment
- Cleft lip and palate
- ASA ≥ III
- Intellectual and/or physical inability to answer questionnaires
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 2 recruiting
- Recruiting
Folktandvården Östergötland
Linköping, 581 91
Emma Göranson, DDS, emma.goranson@regionostergotland.se
- Recruiting
Mikael Sonesson
Malmö, Skåne County, 20506
Mikael Sonesson, Assoc. Prof., mikael.sonesson@mau.se
- Completed
Eastman Institutet Ortodonti
Stockholm, 11324
About this study
Official title: Oral Health Related Quality of Life - The Effect of Malocclusions, Gender, Socioeconomic Differences and Orthodontic Treatment Among Adolescents
Malocclusions in adolescents may affect oral health related quality of life. The study aims at;
- 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).
- Comparing differences in oral health related quality of life in;
- adolescents with different types of malocclusion and without malocclusions
- individuals of different genders and socioeconomic status
- Longitudinally evaluating differences in oral health related quality of life;
- before, during and after orthodontic treatment
- in untreated individuals (without malocclusion) over time
Read the detailed description
The individuals that are to be recruited to the study are;
Malocclusion group; 500 12-19 year olds with malocclusion, examined at their specialist orthodontic clinic.
No malocclusion group; 175 12-19 year olds without malocclusion, examined at their general dentistry clinic.
All patients will also answers two questionnaires (in Swedish) measuring oral health related quality of life; CPQ 11-14 short form (Jokovic 2006, Dimberg 2019) and PIDAQ (Klages 2006, Göranson 2020). Randomization will ensure that half of the study participants will begin with CPQ 11-14 short form and then PIDAQ, while half of the participants will answer the questionnaires in the reverse order. The questionnaires will be answered in a calm environment in the dental clinic.
All patients will have five standardized intraoral photographs taken. These photographs are already routinely taken at the specialist orthodontic clinics, but is taken in addition to routine procedure at the general dentistry clinic. To determine presence of malocclusion and orthodontic treatment need, two orthodontic indices will be used; ICON (Daniels 2000) and IOTN (Brook 1989). Assessments will be based on intraoral photographs, clinical measurements and pre-existing dental x-rays.
Also, patients will be grouped based on their type of malocclusion using the following diagnoses;
- Enlarged overjet (≥ 6 mm) with or without incomplete lip closure
- Anterior cross bite (One or more incisors)
- Deep bite (≥ 2/3 lower incisor coverage)
- Frontal open bite (≤0 mm)
- Lateral cross bite (two or more teeth, with our without lateral guidance)
- Upper or lower arch anterior spacing (largest gap between two neighbouring teeth between canine and canine ≥ 2 mm)
- Upper or lower arch anterior crowding (≥ 3 mm lack of space canine to canine)
As the study is of longitudinal design, the questionnaires will be answered and the photographs will be taken on several occasions. For the malocclusion group, the time points will be as following;
- T0- at the initial examination at the specialist orthodontic clinic, before orthodontic treatment is begun
- T2- One year into the orthodontic treatment
- T3- Two months after the orthodontic treatment has been completed
- T4- One year after the orthodontic treatment has been completed.
The no malocclusion group will be examined the same number of times and at the same time intervals as the malocclusion group.
Information about DMFT/S (decayed, missing, filled, teeth/surfaces will be gathered from the dental records. Orthodontic extractions will be noted. To be able to determine socioeconomic differences, information about socioeconomic status of the individual study participants will be gathered from the Statistics Sweden.
- Conditions
- Malocclusion, Quality of Life, Orthodontics, Adolescent, Socioeconomic Factors
- Being tested
- Malocclusion and Orthodontic Treatment
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malocclusion and Orthodontic TreatmentOther
Group 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 first visit at the orthodontic department, before any orthodontic treatment is begun. Receives: Other: Malocclusion and Orthodontic Treatment | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At start of study, 1 year after start of study, at study completion (an average of 2.5 years), 1 year after study completion
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.
Measured: At start of study, 1 year after start of study, at study completion (an average of 2.5 years), 1 year after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Dec 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 675 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Östergötland, Folktandvården Stockholms län AB
- Responsible party
- Principal investigator, Mikael Sonesson, Malmö University
- Investigators
- Mikael Sonesson, PhD, Principal investigator, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038865
- Sponsor's protocol ID
- 2020-05319
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jokovic A, Locker D, Guyatt G. Short forms of the Child Perceptions Questionnaire for 11-14-year-old children (CPQ11-14): development and initial evaluation. Health Qual Life Outcomes. 2006 Jan 19;4:4. doi: 10.1186/1477-7525-4-4.
PubMed 16423298Dimberg L, Lennartsson B, Bondemark L, Arnrup K. Validity and reliability of the Swedish versions of the short-form Child Perceptions Questionnaire 11-14 and Parental Perceptions Questionnaire. Acta Odontol Scand. 2019 Nov;77(8):630-635. doi: 10.1080/00016357.2019.1634282. Epub 2019 Jul 3.
PubMed 31267808Klages U, Claus N, Wehrbein H, Zentner A. Development of a questionnaire for assessment of the psychosocial impact of dental aesthetics in young adults. Eur J Orthod. 2006 Apr;28(2):103-11. doi: 10.1093/ejo/cji083. Epub 2005 Oct 28.
PubMed 16257989Goranson E, Norevall LI, Bagesund M, Dimberg L. Translation and validation of the Swedish version of the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) for adolescents. Acta Odontol Scand. 2021 May;79(4):241-247. doi: 10.1080/00016357.2020.1823014. Epub 2020 Oct 7.
PubMed 33026890Daniels C, Richmond S. The development of the index of complexity, outcome and need (ICON). J Orthod. 2000 Jun;27(2):149-62. doi: 10.1093/ortho/27.2.149.
PubMed 10867071Brook PH, Shaw WC. The development of an index of orthodontic treatment priority. Eur J Orthod. 1989 Aug;11(3):309-20. doi: 10.1093/oxfordjournals.ejo.a035999.
PubMed 2792220Goranson E, Dimberg L, Naimi-Akbar A, Sonesson M. Malocclusion traits and oral health-related quality of life in adolescents: a multicenter cross-sectional study. Eur J Orthod. 2026 Apr 3;48(3):cjag032. doi: 10.1093/ejo/cjag032.
PubMed 42154991Goranson E, Sonesson M, Gullbrand M, Isberg PE, Dimberg L. The Reliability and Validity of Intraoral Photographs in Assessing Orthodontic Treatment Need. Orthod Craniofac Res. 2025 Jun;28(3):474-484. doi: 10.1111/ocr.12896. Epub 2025 Jan 13.
PubMed 39803929
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Related Quality of Life - The Effect of Malocclusions, Gender, Socioeconomic Differences and Orthodontic Treatment Among Adolescents
- ClinicalTrials.gov ID
- NCT05038865
- Acronym / sponsor ID
- 2020-05319
- Conditions
- Malocclusion, Quality of Life, Orthodontics, Adolescent, Socioeconomic Factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 675 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Region Östergötland, Folktandvården Stockholms län AB
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malocclusions in adolescents may affect oral health related quality of life. The study aims at;
- 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).
- Comparing differences in oral health related quality of life in;
- adolescents with different types of malocclusion and without malocclusions
- individuals of different genders and socioeconomic status
- Longitudinally evaluating differences in oral health related quality of life;
- before, during and after orthodontic treatment
- in untreated individuals (without malocclusion) over time
Detailed description
The individuals that are to be recruited to the study are;
Malocclusion group; 500 12-19 year olds with malocclusion, examined at their specialist orthodontic clinic.
No malocclusion group; 175 12-19 year olds without malocclusion, examined at their general dentistry clinic.
All patients will also answers two questionnaires (in Swedish) measuring oral health related quality of life; CPQ 11-14 short form (Jokovic 2006, Dimberg 2019) and PIDAQ (Klages 2006, Göranson 2020). Randomization will ensure that half of the study participants will begin with CPQ 11-14 short form and then PIDAQ, while half of the participants will answer the questionnaires in the reverse order. The questionnaires will be answered in a calm environment in the dental clinic.
All patients will have five standardized intraoral photographs taken. These photographs are already routinely taken at the specialist orthodontic clinics, but is taken in addition to routine procedure at the general dentistry clinic. To determine presence of malocclusion and orthodontic treatment need, two orthodontic indices will be used; ICON (Daniels 2000) and IOTN (Brook 1989). Assessments will be based on intraoral photographs, clinical measurements and pre-existing dental x-rays.
Also, patients will be grouped based on their type of malocclusion using the following diagnoses;
- Enlarged overjet (≥ 6 mm) with or without incomplete lip closure
- Anterior cross bite (One or more incisors)
- Deep bite (≥ 2/3 lower incisor coverage)
- Frontal open bite (≤0 mm)
- Lateral cross bite (two or more teeth, with our without lateral guidance)
- Upper or lower arch anterior spacing (largest gap between two neighbouring teeth between canine and canine ≥ 2 mm)
- Upper or lower arch anterior crowding (≥ 3 mm lack of space canine to canine)
As the study is of longitudinal design, the questionnaires will be answered and the photographs will be taken on several occasions. For the malocclusion group, the time points will be as following;
- T0- at the initial examination at the specialist orthodontic clinic, before orthodontic treatment is begun
- T2- One year into the orthodontic treatment
- T3- Two months after the orthodontic treatment has been completed
- T4- One year after the orthodontic treatment has been completed.
The no malocclusion group will be examined the same number of times and at the same time intervals as the malocclusion group.
Information about DMFT/S (decayed, missing, filled, teeth/surfaces will be gathered from the dental records. Orthodontic extractions will be noted. To be able to determine socioeconomic differences, information about socioeconomic status of the individual study participants will be gathered from the Statistics Sweden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malocclusion group | – | Other: Malocclusion and Orthodontic Treatment500 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 first visit 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. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Previous orthodontic treatment
- Cleft lip and palate
- ASA ≥ III
- Intellectual and/or physical inability to answer questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Malocclusion and Orthodontic TreatmentGroup 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. | Other | Malocclusion group |
Primary outcome
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
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 completion
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.
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
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 completion
Psychosocial Impact of Dental Aesthetics (PIDAQ) is an instrument measuring orthodontic specific aspects of OHRQoL.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Background: PubMed 16423298Jokovic A, Locker D, Guyatt G. Short forms of the Child Perceptions Questionnaire for 11-14-year-old children (CPQ11-14): development and initial evaluation. Health Qual Life Outcomes. 2006 Jan 19;4:4. doi: 10.1186/1477-7525-4-4.
- Background: PubMed 31267808Dimberg L, Lennartsson B, Bondemark L, Arnrup K. Validity and reliability of the Swedish versions of the short-form Child Perceptions Questionnaire 11-14 and Parental Perceptions Questionnaire. Acta Odontol Scand. 2019 Nov;77(8):630-635. doi: 10.1080/00016357.2019.1634282. Epub 2019 Jul 3.
- Background: PubMed 16257989Klages U, Claus N, Wehrbein H, Zentner A. Development of a questionnaire for assessment of the psychosocial impact of dental aesthetics in young adults. Eur J Orthod. 2006 Apr;28(2):103-11. doi: 10.1093/ejo/cji083. Epub 2005 Oct 28.
- Background: PubMed 33026890Goranson E, Norevall LI, Bagesund M, Dimberg L. Translation and validation of the Swedish version of the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) for adolescents. Acta Odontol Scand. 2021 May;79(4):241-247. doi: 10.1080/00016357.2020.1823014. Epub 2020 Oct 7.
- Background: PubMed 10867071Daniels C, Richmond S. The development of the index of complexity, outcome and need (ICON). J Orthod. 2000 Jun;27(2):149-62. doi: 10.1093/ortho/27.2.149.
- Background: PubMed 2792220Brook PH, Shaw WC. The development of an index of orthodontic treatment priority. Eur J Orthod. 1989 Aug;11(3):309-20. doi: 10.1093/oxfordjournals.ejo.a035999.
- Derived from this study: PubMed 42154991Goranson E, Dimberg L, Naimi-Akbar A, Sonesson M. Malocclusion traits and oral health-related quality of life in adolescents: a multicenter cross-sectional study. Eur J Orthod. 2026 Apr 3;48(3):cjag032. doi: 10.1093/ejo/cjag032.
- Derived from this study: PubMed 39803929Goranson E, Sonesson M, Gullbrand M, Isberg PE, Dimberg L. The Reliability and Validity of Intraoral Photographs in Assessing Orthodontic Treatment Need. Orthod Craniofac Res. 2025 Jun;28(3):474-484. doi: 10.1111/ocr.12896. Epub 2025 Jan 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mikael Sonesson, PhD principal investigator
Malmö University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion and Quality of Life, run by Malmö University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikael Sonesson, PhD (0046406658447, mikael.sonesson@mau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (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 completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05038865, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.