Evaluation of The Effect of Consecutive Dental Visits on Dental Anxiety of Paediatric Patients

Dental Anxiety Clinical Trial

Official title:

Evaluation of The Effect of Consecutive Dental Visits on Dental Anxiety of Paediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06266156
• Other study ID #: BMU-HTUNC-01
• Status: Completed
• Start date: August 5, 2023
• Est. completion date: December 27, 2023

Study information

• Verified date: February 2024
• Source: Burdur Mehmet Akif Ersoy University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about in effect of consecutive dental visits on dental anxiety of paediatric patients.

The main question[s]it aims to answer are:

• Did the anxiety level of pediatric patients decrease in consecutive treatment sessions?

• Were there changes in the physiological parameters related to stress level of pediatric patients in consecutive treatment sessions?

Participants will fill out the questionnaire about dental anxiety in each dental treatment sessions before and after dental treatment.

Researchers will compare paeditric patients have two caries on mandibular molars to see if changes dental anxiety levels and physiological parameters such as heart rates and oxygen saturations during dental treatments in consecutive dental treatment sessions.

Description:

The aim of this study was to investigate the effect of consecutive dental visits on paediatric patients' dental anxiety level in 6-9 years old Turkish children with using of Abeer Children Dental Anxiety scale and physiological parameters.

Determination of Sample Size and Study Design The significance level for the sample size in the study was regulated to show an effect size of 0.83 with a power of 0.05 and 95%. The number of samples (n) was calculated as 200. However, it was decided that the total number of samples (n) would be 260 with data loss foreseen.

According to American Society of Anaesthesiologists (ASA), ASA1 and ASA2 healthy children who 6-9 years old without any learning and physical disabilities, children who don't need to emergency dental applications, children who can speak and understand Turkish, children who have dental caries that involved only dentine and enamel and were included to this study. Children with any disabilities that physical and mental or without parental consent were excluded from this study. In addition to this, children who has a systemic disease with changing the blood pressure, oxygen saturation and heart rate were excluded from this study. 260 children who met the inclusion criteria invited to the study.

Collection of Data and Study Procedure The ACDAS that including three parts as evaluation of child, dental, cognitive and 19 questions was used as a cognitive scale for this study. In the dental part of ACDAS including 13 questions, the children answered these questions using with three types of facial expressions for to show how they felt. All the answers were scored with scale of 1-3. According to the ACDAS children who have score of 26 and above were classified as anxious. The child evaluation and cognitive parts of ACDAS were answered by the paediatric dentist and child's legal guardians. The scores of ACDAS were accepted for master scores. Children were examined by the paediatric dentist as only clinical and radiographical without any dental treatment on first visit.

All participants were recorded, and their appointments were made by the dental assistant. Children were treated with topical anaesthesia (cotton with lidocaine %10 spray) followed by buccal infiltration local anaesthesia (articaine hydrochloride %4) for caries removing of one of the primary molars. The two mandibular primary molars of children were restored with compomer resin with using the rubber dam in first and second visits. All children were directed by same paediatric dentist (HT) with non-pharmacological behaviour management techniques during the dental treatments such as tell-show-do.The treatment duration was approximately 15 minutes. All participants completed to ACDAS for the two times as pre and post operative in both visits.

The objective symptoms of evaluation of dental anxiety such as oxygen saturation and heart rate were included in this study. Heart rate and oxygen saturations of each patient were measured with pulse oximeter (PC-60FL Finger Type Pulse Oxymeter, Galena, TURKEY). The heart rate and oxygen saturation were measured in 5th, 10 th and 15th minutes in first and second visits during dental procedures.

Statistical Analysis All data were analysed with SPSS 22.0 (SPSS for Windows, SPSS Inc, Chicago, IL) and GraphPad Prism software 7.0 for Windows (GraphPad Software, San Diego, California, USA). The sample size of the study was calculated with G-Power (version 3.1.9.7, Heinrich-Heine-Universität Düsseldorf, Germany). Calculation of the normality of the data was using with Kolmorognov-Simirnov test and followed by parametric tests. All data showed normal distribution. Standard deviation (SD) and mean values were shown with numerical variables. Categorical variables were shown with percentages. Two sample t-test were performed for comparing the differences between mean ACDAS score and physiological parameters of first and second visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 27, 2023
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

Inclusion Criteria:

• According to American Society of Anaesthesiologists (ASA), ASA1 and ASA2 healthy children who 6-9 years old without any learning and physical disabilities, children who don't need to emergency dental applications, children who can speak and understand Turkish, children who have dental caries that involved only dentine and enamel and were included to this study.

Exclusion Criteria:

• Children with any disabilities that physical and mental or without parental consent were excluded from this study. In addition to this, children who has a systemic disease with changing the blood pressure, oxygen saturation and heart rate were excluded from this study.

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

Behavioral:
• Score of anxiety questionnaire
All participants were answered the dental anxiety questionnaire.

Diagnostic Test:
• Heart rate
All participants heart rate were measured with finger type pulse oxymeter.
• Oxygen saturation
All participants oxygen saturation were measured with finger type pulse oxymeter.

Locations

Country	Name	City	State
Turkey	Burdur Mehmet Akif Ersoy University Faculty of Dentistry	Burdur	Centrum

Sponsors (1)

Lead Sponsor	Collaborator
Burdur Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of sample size.	The significance level for the sample size in the study was regulated to show an effect size of 0.83 with a power of 0.05 and 95%. The number of samples (n) was calculated as 200. However, it was decided that the total number of samples (n) would be 260 with data loss foreseen.	Before the starting to study
Primary	Inviting participants to the study.	ASA1 and ASA2 healthy children who 6-9 years old without any learning and physical disabilities, children who don't need to emergency dental applications, children who can speak and understand Turkish, children who have dental caries that involved only dentine and enamel and were included to this study. The Abeer Children Dental Anxiety Scale that including three parts as evaluation of child, dental, cognitive and 19 questions was used as a cognitive scale for this study. All the answers were scored with scale of 1-3. Children who have score of 26 and above were classified as anxious. Heart rate and oxygen saturations of each patient were measured with pulse oximeter.	Before the starting to study
Primary	Determination of dental anxiety score of participants before dental treatment in first dental session	All participants completed The Abeer Children Dental Anxiety Scale (ACDAS) before starting treatment.The ACDAS that including three parts as evaluation of child, dental, cognitive and 19 questions was used as a cognitive scale for this study. In the dental part of ACDAS including 13 questions, the children answered these questions using with three types of facial expressions for to show how they felt. All the answers were scored with scale of 1-3. The total scores were ranging between 13 and 39. Children who have score of 26 and above were classified as anxious.	Before the starting to dental treatment in first session.
Primary	Heart rate measuring in first dental session.	The heart rate were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.	Measured at the 5th, 10th and 15th minutes of dental treatment.
Primary	Oxygen saturation measuring in first dental session.	The oxygen saturation were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.	Measured at the 5th, 10th and 15th minutes of dental treatment.
Primary	Determination of dental anxiety score of participants after dental treatment in first dental session	All participants completed the dental anxiety questionnaire after treatment process.	After the dental treatment in first session.
Primary	Determination of dental anxiety score of participants before dental treatment in second dental session	All participants completed the dental anxiety questionnaire before starting treatment.	Before the starting to dental treatment in second session.
Primary	Heart rate measuring in second dental session.	The heart rate were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.	Measured at the 5th, 10th and 15th minutes of dental treatment.
Primary	Oxygen saturation measuring in second dental session.	The oxygen saturation were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.	Measured at the 5th, 10th and 15th minutes of dental treatment.
Primary	Determination of dental anxiety score of participants after dental treatment in second dental session	All participants completed the dental anxiety questionnaire after treatment process.	After the dental treatment in second session.