Oral Findings in Children of Multiple and Single BirthsNCT04697017
Clinical and Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births
A study testing The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births in people with Oral Findings in Children of Multiple and Single Births and Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births, run by Suleyman Demirel University at 2 sites in Turkey (Türkiye).
Trial summary
Clinical and radiographic evaluation of oral findings in children of multiple and single births Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Findings in Children of Multiple and Single Births, Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births
- What is being tested?
- The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Jan 2018to 10 Sep 2021
- Phase
- Interventional
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Twins, triplets and singletons who had not
- developmental anomalies such as cleft lip and palate
- premature tooth loss
- systemic diseases or syndromes that could influence oral health
- already undergone or were undergoing orthodontic therapy
Who cannot join
- Twins, triplets and singletons who had
- developmental anomalies such as cleft lip and palate
- premature tooth loss
- systemic diseases or syndromes that could influence oral health
- already undergone or were undergoing orthodontic therapy
- those whose family did not give consent
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
Isparta, 32260
Esra
Isparta
About this study
Official title: Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
Clinical and radiographic evaluation of oral findings in children of multiple and single births
Read the detailed description
In this study, the study groups comprised MZ and DZ twin pairs, triplets and singletons between the ages of 2 and 17 who attended the Department of Pediatric Dentistry at Suleyman Demirel University between January 2018 and September 2020. Twins and triplets who had developmental anomalies such as cleft lip and palate, premature tooth loss, systemic diseases or syndromes that could influence oral health or had already undergone or were undergoing orthodontic therapy, as well as those whose family did not give consent, were excluded from the study.
All children were assessed by the same experienced pedodontist (E.O.) to avoid interexaminer variability. The oral examination was performed using sterile mouth mirror and probe. The prevalence of dental caries was recorded using dmft index (decayed, missing and filled teeth) in primary dentition and DMFT index (Decayed, Missing and Filled teeth) in permanent dentition. When evaluating patients over 6 years old, the missing tooth component was not included in the primary dft scores.
Oral hygiene practices, such as tooth brushing frequency and the children's past or present oral habits (digit sucking, nail biting, tongue thrust, bruxism, lip biting, pencil biting, cheek biting and mouth breathing), were also recorded.
The primary molar relationships were evaluated as flush terminal plane and mesial and distal step. The permanent molar relationships were recorded as Class I, Class II (Division 1 and 2) and Class III. Occlusal traits such as increased overjet, deep bite, open bite and anterior and posterior crossbite were recorded as present (1) or absent (0) with the help of a dental probe
- Conditions
- Oral Findings in Children of Multiple and Single Births, Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births
- Being tested
- The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births
- Keywords
- dental caries, multiple births, oral habits, singletons, twins
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple birthsOther
The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births
| Study group | Role | What they receive |
|---|---|---|
| Multiple births (twins and triplets) | Other | Twins and triplets who had developmental anomalies such as cleft lip and palate, premature tooth loss, systemic diseases or syndromes that could influence oral health or had already undergone or were undergoing orthodontic therapy, as well as those whose family did not give consent, were excluded from the study Receives: Other: The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births |
| Singletons | Other | Singletons who had developmental anomalies such as cleft lip and palate, premature tooth loss, systemic diseases or syndromes that could influence oral health or had already undergone or were undergoing orthodontic therapy, as well as those whose family did not give consent, were excluded from the study. Receives: Other: The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical examination of dental caries
The prevalence of dental caries was recorded using dmft index (decayed, missing and filled teeth) in primary dentition and DMFT index (Decayed, Missing and Filled teeth) in permanent dentition. When evaluating patients over 6 years old, the missing tooth component was not included in the primary dft scores.
Measured: Baseline
Evaluation of molar relationship
The primary molar relationships were evaluated as flush terminal plane and mesial and distal step. The permanent molar relationships were recorded as Class I, Class II (Division 1 and 2) and Class III
Measured: Baseline
Number of participants with oral habits
the children's past or present oral habits (digit sucking, nail biting, tongue thrust, bruxism, lip biting, pencil biting, cheek biting and mouth breathing) were recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start10 Jan 2018
- Primary completion10 Sep 2020
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Findings in Children of Multiple and Single BirthsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Oz, Suleyman Demirel University
- Investigators
- Esra Oz, Principal investigator, Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697017
- Sponsor's protocol ID
- 232
- Status last verified
- Jul 2022
- First submitted
- 2 Jan 2021
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
- ClinicalTrials.gov ID
- NCT04697017
- Acronym / sponsor ID
- 232
- Conditions
- Oral Findings in Children of Multiple and Single Births, Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births
- Keywords
- dental caries, multiple births, oral habits, singletons, twins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 6 Jan 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.
Clinical and radiographic evaluation of oral findings in children of multiple and single births
Detailed description
In this study, the study groups comprised MZ and DZ twin pairs, triplets and singletons between the ages of 2 and 17 who attended the Department of Pediatric Dentistry at Suleyman Demirel University between January 2018 and September 2020. Twins and triplets who had developmental anomalies such as cleft lip and palate, premature tooth loss, systemic diseases or syndromes that could influence oral health or had already undergone or were undergoing orthodontic therapy, as well as those whose family did not give consent, were excluded from the study.
All children were assessed by the same experienced pedodontist (E.O.) to avoid interexaminer variability. The oral examination was performed using sterile mouth mirror and probe. The prevalence of dental caries was recorded using dmft index (decayed, missing and filled teeth) in primary dentition and DMFT index (Decayed, Missing and Filled teeth) in permanent dentition. When evaluating patients over 6 years old, the missing tooth component was not included in the primary dft scores.
Oral hygiene practices, such as tooth brushing frequency and the children's past or present oral habits (digit sucking, nail biting, tongue thrust, bruxism, lip biting, pencil biting, cheek biting and mouth breathing), were also recorded.
The primary molar relationships were evaluated as flush terminal plane and mesial and distal step. The permanent molar relationships were recorded as Class I, Class II (Division 1 and 2) and Class III. Occlusal traits such as increased overjet, deep bite, open bite and anterior and posterior crossbite were recorded as present (1) or absent (0) with the help of a dental probe
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple births (twins and triplets) | Other | Other: The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple birthsTwins and triplets who had developmental anomalies such as cleft lip and palate, premature tooth loss, systemic diseases or syndromes that could influence oral health or had already undergone or were undergoing orthodontic therapy, as well as those whose family did not give consent, were excluded from the study |
| Singletons | Other | Other: The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple birthsSingletons who had developmental anomalies such as cleft lip and palate, premature tooth loss, systemic diseases or syndromes that could influence oral health or had already undergone or were undergoing orthodontic therapy, as well as those whose family did not give consent, were excluded from the study. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Twins, triplets and singletons who had not
Key exclusion criteria (6 listed)
- Twins, triplets and singletons who had
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 |
|---|---|---|
| The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple birthsThe contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births | Other | Multiple births (twins and triplets), Singletons |
Primary outcome
Clinical examination of dental caries
Time frame: Baseline
The prevalence of dental caries was recorded using dmft index (decayed, missing and filled teeth) in primary dentition and DMFT index (Decayed, Missing and Filled teeth) in permanent dentition. When evaluating patients over 6 years old, the missing tooth component was not included in the primary dft scores.
Evaluation of molar relationship
Time frame: Baseline
The primary molar relationships were evaluated as flush terminal plane and mesial and distal step. The permanent molar relationships were recorded as Class I, Class II (Division 1 and 2) and Class III
Number of participants with oral habits
Time frame: Baseline
the children's past or present oral habits (digit sucking, nail biting, tongue thrust, bruxism, lip biting, pencil biting, cheek biting and mouth breathing) were recorded.
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 7 Jul 2022.
- Individual participant dataSharing planned: No
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.
Esra Oz principal investigator
Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births in people with Oral Findings in Children of Multiple and Single Births and Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births, run by Suleyman Demirel University 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 5 inclusion and 6 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 7 Jul 2022. 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?
Clinical examination of dental caries (time frame: Baseline). 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 7 Jul 2022.