The Effect of Malocclusions on Oral Health Related Quality of Life

NCT05038865 | Recruiting

• 1 other identifier: 2020-05319
• Study Type: observational
• Target: 675
• Locations: 1 country
• Sites: 3

Brief Summary

Malocclusions in adolescents may affect oral health related quality of life. The study aims at;

1. 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. 2.Comparing differences in oral health related quality of life in;
3. 3.adolescents with different types of malocclusion and without malocclusions
4. 4.individuals of different genders and socioeconomic status
5. 5.Longitudinally evaluating differences in oral health related quality of life;
6. 6.before, during and after orthodontic treatment
7. 7.in untreated individuals (without malocclusion) over time

Conditions

Malocclusion; Quality of Life; Orthodontics; Adolescent; Socioeconomic Factors

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At start of study, 1 year after start of study, at study completion (an average of 2.5 years), 1 year after study completion

Study Arms (2)

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.

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.

Interventions

Malocclusion and Orthodontic Treatment OTHER

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.

Malocclusion group

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Previous orthodontic treatment
• Cleft lip and palate
• ASA ≥ III
• Intellectual and/or physical inability to answer questionnaires

Sponsors & Collaborators

• Malmö University: lead
• Region Östergötland: collaborator
• Folktandvården Stockholms län AB: collaborator

Study Sites (3)

Mikael Sonesson

Malmo, Skåne County, 20506, Sweden

RECRUITING

Folktandvården Östergötland

Linköping, 581 91, Sweden

RECRUITING

Eastman Institutet Ortodonti

Stockholm, 11324, Sweden

COMPLETED

Related Publications (7)

• 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.

  PMID: 16423298 BACKGROUND

• Dimberg 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.

  PMID: 31267808 BACKGROUND

• Klages 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.

  PMID: 16257989 BACKGROUND

• Goranson 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.

  PMID: 33026890 BACKGROUND

• Daniels 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.

  PMID: 10867071 BACKGROUND

• Brook 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.

  PMID: 2792220 BACKGROUND

• Goranson 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.

  PMID: 39803929 DERIVED

MeSH Terms

Conditions

Malocclusion

Interventions

Orthodontics

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Mikael Sonesson, PhD

  Malmö University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Sonesson, PhD

CONTACT

0046406658447; mikael.sonesson@mau.se

Emma Göranson, DDS

CONTACT

0046739220078; emma.goranson@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: September 9, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 4, 2023

Record last verified: 2023-03

Locations

SE (3)