- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04697017
Clinical and Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births
Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Isparta, Turkey, 32260
- Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
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Isparta, Turkey
- Esra
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Multiple births (twins and triplets)
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
|
The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births
|
Other: Singletons
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.
|
The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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
|
Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Esra Oz, Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 232
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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