Clinical and Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births

July 4, 2022 updated by: Esra Oz, Suleyman Demirel University

Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department

Clinical and radiographic evaluation of oral findings in children of multiple and single births

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
690

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Isparta, Turkey, 32260
        • Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
      • Isparta, Turkey
        • Esra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births
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.
Other: The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suleyman Demirel University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Esra Oz, Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oral Findings in Children of Multiple and Single Births

Clinical Trials on The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings