Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05038865
Status:
RECRUITING
Last Update Posted:
2023-04-04
First Post:
2021-02-22
Brief Title:
The Effect of Malocclusions on Oral Health Related Quality of Life
Sponsor:
Malmö University
Organization:
Malmö University
Study Overview
Official Title:
Oral Health Related Quality of Life - The Effect of Malocclusions Gender Socioeconomic Differences and Orthodontic Treatment Among Adolescents
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 23 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 DMFTS decayed missing filled teethsurfaces 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
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 23 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 DMFTS decayed missing filled teethsurfaces 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None