Dental Caries in ChildrenNCT03039010
Validation of Data for Dental Health in the SKaPa Registry for Children and Adolescents
An observational study of Dental Caries in Children, run by Tita Mensah at 1 site in Sweden.
Trial summary
Swedish Quality Registry for dental health care (SKaPa) is a national registry that has since year 2008 gathered dental data. The data is automatically extracted from the patients' electronical dental data records. A vast majority of the public dental health care clinics deliver data on a daily basis (SKaPa, 2013). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Dental Caries in Children
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2017to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Child
Study population: Study part 1: A total of 170 individuals (6-year-olds and 12-year-olds) will be included. Part 2: A total of 500 individuals patient journals.
Who may be able to join
- The inclusion of patients for the clinical dental examinations is based on cluster sampling (dental clinic in the Public Dental Service) in Värmland.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Sweden1 site
National dental Service, Folktandvården Värmland
Karlstad, Värmland County, 65220
About this study
Swedish Quality Registry for dental health care (SKaPa) is a national registry that has since year 2008 gathered dental data. The data is automatically extracted from the patients' electronical dental data records. A vast majority of the public dental health care clinics deliver data on a daily basis (SKaPa, 2013). SKaPa has the purpose to improve and develop the quality of care and patient outcomes for both prevention and reparative/restorative methods concerning caries and periodontal disease. For children and adolescents, it is above all information related to dental caries that is collected (SKaPa, 2013). So far, SKaPa has published seven annual reports. In the report for year 2013 a limited information about the status of children was given, due to uncertainty in the quality of the information that is passed on to SKaPa (SKaPa, 2013). There is therefore a need to examine the validity of the data supplied to SKaPa.
Tooth decay is the most common disease in children and adolescents that often lead to invasive interventions and pain. There are reports of great social disparities in dental health in children and adolescents in Sweden (The National Board of Health and Welfare, Socialstyrelsen, 2013). Because tooth decay is a common disease in children, it is important to be able to monitor the occurrence of the disease and also examine how it differs across various groups of children and adolescents. This is now possible through the several registries that are available in the dental and health care. Register-based research will be an important tool to ensure that children and adolescents receive oral health and dental care on the same premise as others, provided the data in the registries are valid. Furthermore, register-based research is important for development and quality assurance of dental care.
Read the detailed description
Validation of data for dental health in the SKaPa registry for children and adolescents.
Research question: How reliable is the information on dental caries of children and adolescents in the SKaPa registry?
Hypothesis: Data to SKaPa differences minimally compared with medical records and clinical status when it comes to deft/DMFT for 6 and 12 year old children. There is an underregistration of dental caries due to not registering caries that will not be treated. The children that are examined with bite-wings will have a higher score of deft/DMFT than other children.
Method: Tooth decay is examined clinically by trained and calibrated dentists in 170 6-year-olds and12-year-olds will be included. The registrations are compared with the most recently collected data for individuals in SKaPa to evaluate the quality of the information in the SKaPa registry. The inclusion of patients for the clinical dental examinations is based on cluster sampling (dental clinic in the Public Dental Service) in Värmland. The exact number of individuals being examined is determined after power calculation in collaboration with a Biostatistician.
Furthermore, a randomized sample of 500 individuals where data reported to SKaPa for the year 2014 will included for evaluation of dental records and dental radiographs. Comparisons are made between the data in the registry with the original data in the patient record. Preliminary calculated 250 6-year-olds and 250 12-year-olds will be included. Study population size is determined after power-calculation and in collaboration with a statistician. The study would make it possible to detect differences in deft/DMFT at 10% with a standard deviation of 30%. The reviews of the dental records are made by two calibrated dentists. The consistency of registrations from dental records and radiographs are continually evaluated throughout study. Primary outcome measures in both the clinical part and the dental record survey are number of teeth and deft/ DMFT.
The following data are registered:
- Status: Number of teeth, which teeth, manifest caries
- Radiographs - manifest caries lesions, and quality of radiographs - for example; possi-bility to see all interdental spaces, overlaps, marginal bone, quality of radiographic exposure
- Recordings in the dental records about patient's health status, medications, risk assessment
- Therapy decisions about diagnosed manifest tooth decay
- Undiagnosed manifest caries
- Prevention treatments
- Which dental profession the child has met (dentist/dental hygienist/dental assistant)
- Decision about when the next examination is planned
- When the previous examination was done, was X-rays taken (yes/no), diagnosed caries initially/manifest/or not
- Conditions
- Dental Caries in Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of teeth and deft/ DMFT
The dental caries index DMFT is commonly used to measure caries prevalence. DMFT means Decayed, Missing, Filled Teeth, i.e. carious, missing (due to tooth decay) and filled teeth in permanent dentition. In the primary dentition the terms used are; d (decayed), e (extracted) and f (filled) teeth.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tita Mensah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tita Mensah, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039010
- Sponsor's protocol ID
- MalmoU
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mensah T, Tranaeus S, Cederlund A, Naimi-Akbar A, Klingberg G. Swedish quality registry for caries and periodontal diseases (SKaPa): validation of data on dental caries in 6- and 12-year-old children. BMC Oral Health. 2021 Jul 24;21(1):373. doi: 10.1186/s12903-021-01705-x.
PubMed 34301237
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Data for Dental Health in the SKaPa Registry for Children and Adolescents
- ClinicalTrials.gov ID
- NCT03039010
- Acronym / sponsor ID
- MalmoU
- Conditions
- Dental Caries in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tita MensahUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 1 Feb 2017 (estimated)
- 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.
Swedish Quality Registry for dental health care (SKaPa) is a national registry that has since year 2008 gathered dental data. The data is automatically extracted from the patients' electronical dental data records. A vast majority of the public dental health care clinics deliver data on a daily basis (SKaPa, 2013). SKaPa has the purpose to improve and develop the quality of care and patient outcomes for both prevention and reparative/restorative methods concerning caries and periodontal disease. For children and adolescents, it is above all information related to dental caries that is collected (SKaPa, 2013). So far, SKaPa has published seven annual reports. In the report for year 2013 a limited information about the status of children was given, due to uncertainty in the quality of the information that is passed on to SKaPa (SKaPa, 2013). There is therefore a need to examine the validity of the data supplied to SKaPa.
Tooth decay is the most common disease in children and adolescents that often lead to invasive interventions and pain. There are reports of great social disparities in dental health in children and adolescents in Sweden (The National Board of Health and Welfare, Socialstyrelsen, 2013). Because tooth decay is a common disease in children, it is important to be able to monitor the occurrence of the disease and also examine how it differs across various groups of children and adolescents. This is now possible through the several registries that are available in the dental and health care. Register-based research will be an important tool to ensure that children and adolescents receive oral health and dental care on the same premise as others, provided the data in the registries are valid. Furthermore, register-based research is important for development and quality assurance of dental care.
Detailed description
Validation of data for dental health in the SKaPa registry for children and adolescents.
Research question: How reliable is the information on dental caries of children and adolescents in the SKaPa registry?
Hypothesis: Data to SKaPa differences minimally compared with medical records and clinical status when it comes to deft/DMFT for 6 and 12 year old children. There is an underregistration of dental caries due to not registering caries that will not be treated. The children that are examined with bite-wings will have a higher score of deft/DMFT than other children.
Method: Tooth decay is examined clinically by trained and calibrated dentists in 170 6-year-olds and12-year-olds will be included. The registrations are compared with the most recently collected data for individuals in SKaPa to evaluate the quality of the information in the SKaPa registry. The inclusion of patients for the clinical dental examinations is based on cluster sampling (dental clinic in the Public Dental Service) in Värmland. The exact number of individuals being examined is determined after power calculation in collaboration with a Biostatistician.
Furthermore, a randomized sample of 500 individuals where data reported to SKaPa for the year 2014 will included for evaluation of dental records and dental radiographs. Comparisons are made between the data in the registry with the original data in the patient record. Preliminary calculated 250 6-year-olds and 250 12-year-olds will be included. Study population size is determined after power-calculation and in collaboration with a statistician. The study would make it possible to detect differences in deft/DMFT at 10% with a standard deviation of 30%. The reviews of the dental records are made by two calibrated dentists. The consistency of registrations from dental records and radiographs are continually evaluated throughout study. Primary outcome measures in both the clinical part and the dental record survey are number of teeth and deft/ DMFT.
The following data are registered:
- Status: Number of teeth, which teeth, manifest caries
- Radiographs - manifest caries lesions, and quality of radiographs - for example; possi-bility to see all interdental spaces, overlaps, marginal bone, quality of radiographic exposure
- Recordings in the dental records about patient's health status, medications, risk assessment
- Therapy decisions about diagnosed manifest tooth decay
- Undiagnosed manifest caries
- Prevention treatments
- Which dental profession the child has met (dentist/dental hygienist/dental assistant)
- Decision about when the next examination is planned
- When the previous examination was done, was X-rays taken (yes/no), diagnosed caries initially/manifest/or not
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Study part 1: A total of 170 individuals (6-year-olds and 12-year-olds) will be included. Part 2: A total of 500 individuals patient journals.
Key inclusion criteria (1 listed)
- The inclusion of patients for the clinical dental examinations is based on cluster sampling (dental clinic in the Public Dental Service) in Värmland.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of teeth and deft/ DMFT
Time frame: 10 minutes
The dental caries index DMFT is commonly used to measure caries prevalence. DMFT means Decayed, Missing, Filled Teeth, i.e. carious, missing (due to tooth decay) and filled teeth in permanent dentition. In the primary dentition the terms used are; d (decayed), e (extracted) and f (filled) teeth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Derived from this study: PubMed 34301237Mensah T, Tranaeus S, Cederlund A, Naimi-Akbar A, Klingberg G. Swedish quality registry for caries and periodontal diseases (SKaPa): validation of data on dental caries in 6- and 12-year-old children. BMC Oral Health. 2021 Jul 24;21(1):373. doi: 10.1186/s12903-021-01705-x.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries in Children, run by Tita Mensah at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of teeth and deft/ DMFT (time frame: 10 minutes). 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 NCT03039010, which also lists 1 linked publication.
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 11 Feb 2020.