Oral HealthNCT06162754
What do Parents Know About Space Maintainers
An observational study of Oral Health and Dental Caries in Children, run by Recep Tayyip Erdogan University Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Space maintainers are frequently used to prevent malocclusion problems in early primary tooth loss. Oral health literacy is defined as the capacity of individuals to learn, understand and evaluate basic oral health information. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Health, Dental Caries in Children, Tooth Loss
- What is being tested?
- A questionnaire and TREALD scales were applied to parents.
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Aug 2022to 30 Dec 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: children who applied for the dental trearment to the Faculty of Dentistry in Rize
Who may be able to join
- Patients who did not require urgent treatment,
- Who did not use medication for psychiatric reasons,
- Who did not have any mental illness were included.
Who cannot join
- Those who did not meet the inclusion criteria were excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Recep Tayyip Erdogan University Training and Research Hospital
Rize, 53100
Sema AYDINOGLU
Rize
About this study
Official title: What do Parents Know About Space Maintainers: Its Relationship With Parents' Oral Health Literacy and Children's Oral Health
Space maintainers are frequently used to prevent malocclusion problems in early primary tooth loss. Oral health literacy is defined as the capacity of individuals to learn, understand and evaluate basic oral health information. It is considered that parents' awareness of space maintainers may be affected by various factors such as their demographic characteristics and oral health literacy. The aim was to evaluate the relationship between variables by determining parents' awareness of space maintainers and their oral health literacy.
Read the detailed description
This cross-sectional study included 600 children and their parents. The survey, which included questions about sociodemographic characteristics and space maintainer awareness, was administered to parents face to face. Then, parents' oral health literacy levels were measured with TREALD-30 and TREALD-30A scales.
- Conditions
- Oral Health, Dental Caries in Children, Tooth Loss
- Being tested
- A questionnaire and TREALD scales were applied to parents.
- Keywords
- oral health literacy, space maintainer, dental caries
- Medical subject headings
- Tooth Loss, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A questionnaire and TREALD scales were applied to parents.Other
The survey, which included questions about sociodemographic characteristics and space maintainer awareness, was administered to parents face to face. Then, parents' oral health literacy levels were measured with TREALD-30 and TREALD-30A scales.
What is being measured
The primary outcome is the main question the study is designed to answer.
the knowledge about space maintainers of the parents
15 questions that evaluates the awareness about space maintainers of parents was applied face to face.
Measured: for three months from the beginning of the study
oral health literacy of the parents
Oral health literacy of parents was assessed using the Turkish Rapid Estimate of Adult Literacy in Dentistry (TREALD-30 ) scale.
Measured: for three months from the beginning of the study
oral health literacy of the parents assessed by TREALD-30A scale
Oral health literacy of parents was assessed using the Turkish Rapid Estimate of Adult Literacy in Dentistry (TREALD-30A) scale.
Measured: for three months from the beginning of the study
Secondary outcomes (1)
the correlation between oral health literacy and knowledge about space maintainers of parents
the correlation between oral health literacy and knowledge about space maintainers of parents was assessed using TREALD scales and a questionnaire.
Measured: for three months from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start30 Aug 2022
- Primary completion30 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Aydınoglu, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Sema AYDINOGLU, Principal investigator, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162754
- Sponsor's protocol ID
- 2022/140
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What do Parents Know About Space Maintainers: Its Relationship With Parents' Oral Health Literacy and Children's Oral Health
- ClinicalTrials.gov ID
- NCT06162754
- Acronym / sponsor ID
- 2022/140
- Conditions
- Oral Health, Dental Caries in Children, Tooth Loss
- Keywords
- oral health literacy, space maintainer, dental caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 8 Dec 2023 (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.
Space maintainers are frequently used to prevent malocclusion problems in early primary tooth loss. Oral health literacy is defined as the capacity of individuals to learn, understand and evaluate basic oral health information. It is considered that parents' awareness of space maintainers may be affected by various factors such as their demographic characteristics and oral health literacy. The aim was to evaluate the relationship between variables by determining parents' awareness of space maintainers and their oral health literacy.
Detailed description
This cross-sectional study included 600 children and their parents. The survey, which included questions about sociodemographic characteristics and space maintainer awareness, was administered to parents face to face. Then, parents' oral health literacy levels were measured with TREALD-30 and TREALD-30A scales.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- children who applied for the dental trearment to the Faculty of Dentistry in Rize
Key inclusion criteria (3 listed)
- Patients who did not require urgent treatment,
- Who did not use medication for psychiatric reasons,
- Who did not have any mental illness were included.
Key exclusion criteria (1 listed)
- Those who did not meet the inclusion criteria were excluded from the study.
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 |
|---|---|---|
| A questionnaire and TREALD scales were applied to parents.The survey, which included questions about sociodemographic characteristics and space maintainer awareness, was administered to parents face to face. Then, parents' oral health literacy levels were measured with TREALD-30 and TREALD-30A scales. | Other | – |
Primary outcome
the knowledge about space maintainers of the parents
Time frame: for three months from the beginning of the study
15 questions that evaluates the awareness about space maintainers of parents was applied face to face.
oral health literacy of the parents
Time frame: for three months from the beginning of the study
Oral health literacy of parents was assessed using the Turkish Rapid Estimate of Adult Literacy in Dentistry (TREALD-30 ) scale.
oral health literacy of the parents assessed by TREALD-30A scale
Time frame: for three months from the beginning of the study
Oral health literacy of parents was assessed using the Turkish Rapid Estimate of Adult Literacy in Dentistry (TREALD-30A) scale.
1 secondary outcome
the correlation between oral health literacy and knowledge about space maintainers of parents
Time frame: for three months from the beginning of the study
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 8 Dec 2023.
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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.
Sema AYDINOGLU principal investigator
Recep Tayyip Erdogan University Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health and Dental Caries in Children, run by Recep Tayyip Erdogan University Training and Research Hospital at 2 sites in Turkey (Türkiye).
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 3 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
the knowledge about space maintainers of the parents (time frame: for three months from the beginning of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2023.