NCT04967300

Brief Summary

Dental anxiety is defined as the fear of terrible events during dental treatment and the loss of control.Anxiety may be related to adaptation of the patient to external factors in environment, so the adaptation of the pediatric patient to the stimuli in the dental environment may affect the level of anxiety.The aim of the this study was to evaluate the relationship between sequential visits in dental treatments and dental anxiety levels of pediatric patients with anxiety scales and physiological measurements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

June 8, 2021

Last Update Submit

July 16, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Dental anxiety

    The Modified Corah's Dental Anxiety Scale minimum 5 points maximum 25 points more than 15 points means patient have dental axiety .Higher points mean worse outcome

    at the first dental visit, during two weeks

  • Dental anxiety

    The Modified Corah's Dental Anxiety Scale minimum 5 points maximum 25 points more than 15 points means patient have dental axiety .Higher points mean worse outcome

    at the second dental visit, during two weeks

Study Arms (2)

First Visit

Children who visit dentist at first time

Procedure: Dental treatment

Second Visit

Children who visit dentist at second time

Procedure: Dental treatment

Interventions

bilateral restorative treatment on the mandibular primary first molars

First VisitSecond Visit

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A total of 224 children aged 5-8 years who needed at least two restorative dental treatments of the mandibular first primary molar were included in the study. As the inclusion criteria, children with no mental disorders, with no past dental experience, hospitalization or invasive medical treatments, and no pain or symptom in their oral health. All included children and parents had to spoken and understood the Turkish language. Patients with chronic systemic illnesses that may affect the blood pressure or heart rate of a child were excluded from the study. Only children who required multiple-visit treatments were taken into consideration.

You may qualify if:

  • Children aged 5-8 years
  • Children who need at least two restorative dental treatments of the mandibular first primary molar

You may not qualify if:

  • Chronic systemic illnesses
  • Dental experience
  • Mental disorders
  • Invasive medical treatments
  • Hospitalization
  • Oral health problems with a painful history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nurcan Kutluer Karaca

Erzincan, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dental Care

Intervention Hierarchy (Ancestors)

DentistryDental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

June 8, 2021

First Posted

July 19, 2021

Study Start

March 1, 2020

Primary Completion

July 30, 2020

Study Completion

August 30, 2020

Last Updated

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations