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

Sponsor

Suleyman Demirel University (Other)

Overall Status

Completed

CT.gov ID

NCT04697017

Collaborator

(none)

690

Enrollment

Locations

Arms

Actual Duration (Months)

345

Patients Per Site

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Oral Findings in Children of Multiple and Single Births Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births	Other: The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births	N/A

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

Study Type:

Interventional

Actual Enrollment :

690 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

Official Title:

Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department

Actual Study Start Date :

Jan 10, 2018

Actual Primary Completion Date :

Sep 10, 2020

Actual Study Completion Date :

Sep 10, 2021

Arms and Interventions

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	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

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

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

Outcome Measures

Primary Outcome Measures

Clinical examination of dental caries [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department	Isparta		Turkey	32260
2	Esra	Isparta		Turkey

Sponsors and Collaborators

Suleyman Demirel University

Investigators

Principal Investigator: Esra Oz, Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Esra Oz, Assistant professor, Suleyman Demirel University

ClinicalTrials.gov Identifier:

NCT04697017

Other Study ID Numbers:

First Posted:

Jan 6, 2021

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Esra Oz, Assistant professor, Suleyman Demirel University

Additional relevant MeSH terms:

Salicylic Acid

Study Results

No Results Posted as of Jul 7, 2022