Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments

Dental Anxiety Clinical Trial

Official title:

Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments: A Retrospective Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967300
• Other study ID #: Erzincan Binali Yildirim U.
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: July 2021
• Source: Erzincan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

A total of 224 children aged 5-8 years who needed at least two restorative dental treatment of the mandibular first primary molar were included in the study. In each sessions the Wong-Baker FACES Pain Rating Scale (W-BFRS) was used to evaluate the dental anxiety before and after the treatment. The Modified Corah's Dental Anxiety Scale (MDAS) was used as a dental anxiety measurement method. A portable finger pulse oximeter (Nellcor™ PMN10, Medtronic Corp. MN, USA) was used to measure the heart rate. Data were statistically analyzed with the help of the Statistical Package for Social Sciences statistical software (SPSS 18.0), considering a 5% significance level. Nonparametric tests were used. Normality assumption was evaluated with the Kolmogorov Smirnov test. The association between two groups was analyzed by Wilcoxon Signed Rank Test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: August 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

Procedure:
• Dental treatment
bilateral restorative treatment on the mandibular primary first molars

Locations

Country	Name	City	State
Turkey	Nurcan Kutluer Karaca	Erzincan

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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