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Completed

NCT Number: NCT04967300

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

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.

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Key information

Conditions

Dental Anxiety

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nurcan Kutluer Karaca

Erzincan, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental treatment

Procedure

bilateral restorative treatment on the mandibular primary first molars

Primary outcomes

  1. Dental anxiety

    Time frame: at the first dental visit, during two weeks

    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

  2. Dental anxiety

    Time frame: at the second dental visit, during two weeks

    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

Sponsors and collaborators

Lead sponsor

Erzincan University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2021
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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