NCT04122508

Brief Summary

Neglect insidiously affects a child's overall health in all aspects. The aim of this study was to determine whether the presence of siblings caused dental neglect, and whether there was a relationship between dental neglect and anxiety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
Last Updated

October 11, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 5, 2019

Last Update Submit

October 9, 2019

Conditions

Keywords

anxietysiblingsdental cariesoral healthchild abuse

Outcome Measures

Primary Outcomes (4)

  • the effects of presence of siblings on dental neglect

    The effects of presence of siblings on oral health and dental neglect was assessed using dental neglect scale. The dental neglect scale for children was originally composed of seven statements, using a Likert scale ranging from one to five . The total score of DNS can range from 7 to 35, with higher scores representing greater dental neglect.

    for eight months from the beginning of the study

  • the effects of presence of siblings on oral health

    the effects of presence of siblings on oral health and dental neglect was assessed using oral hygiene index . The OHI-S has two elements, the Debris Index and the Calculus Index. The Debris Index and the Calculus Index can range from 0 to 3, the oral hygiene index values from 0 to 6.

    for eight months from the beginning of the study

  • the effects of presence of siblings on dental caries

    the effects of presence of siblings on oral health and dental neglect was assessed using, DMFT/dmft index. caries (D/d), missing due to caries (M/m), filling (F/f) teeth were recorded using DMF-T indices for permanent teeth and dmf-t indices for primary teeth.

    for eight months from the beginning of the study

  • the effects of presence of siblings on untreated caries

    the effects of presence of siblings on oral health and dental neglect was assessed using pufa index. The index recorded the presence of visible pulp involvement (P/p), mucosal ulceration due to root fragments (U/u), fistulae (F/f) and/or abscessess (A/a). Higher scores represents worse oral health.

    for eight months from the beginning of the study

Secondary Outcomes (1)

  • to evaluate whether there was a correlation between dental neglect and anxiety in children

    for eight months from the beginning of the study

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children who presented for the first time to the Faculty of Dentistry in Rize

You may qualify if:

  • Aged between 6 and 12 years old
  • Being healthy
  • Being volunteer for the study

You may not qualify if:

  • Systemic and mental disorders
  • Syndromes or other major health diseases
  • Cooperation problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University Training and Research Hospital

Rize, 53100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Child BehaviorDental CariesAnxiety Disorders

Condition Hierarchy (Ancestors)

BehaviorTooth DemineralizationTooth DiseasesStomatognathic DiseasesMental Disorders

Study Officials

  • Sema Aydınoglu, Dr

    Recep Tayyip Erdogan University Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 5, 2019

First Posted

October 10, 2019

Study Start

January 1, 2019

Primary Completion

July 31, 2019

Study Completion

September 30, 2019

Last Updated

October 11, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available 5 years after publication
Access Criteria
Data access requests will be reviewed by authors.

Locations