Dental AnxietyNCT06266156
Evaluation of The Effect of Consecutive Dental Visits on Dental Anxiety of Paediatric Patients
An observational study of Dental Anxiety, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Score of anxiety questionnaire, Heart rate and Oxygen saturation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2023to 27 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 6-9 years who meet the inclusion criteria and needed at least two restorative dental treatments of the mandibular first primary molar were included in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University Faculty of Dentistry
Burdur, Centrum, 15100
About this study
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Dental Anxiety
- Being tested
- Score of anxiety questionnaire, Heart rate, Oxygen saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Score of anxiety questionnaireBehavioural
All participants were answered the dental anxiety questionnaire.
Heart rateDiagnostic test
All participants heart rate were measured with finger type pulse oxymeter.
Oxygen saturationDiagnostic test
All participants oxygen saturation were measured with finger type pulse oxymeter.
| Study group | Role | What they receive |
|---|---|---|
| Firts Dental Visit | Dental anxiety level, heart rate and oxygen saturation of participants in first dental visit. Receives: Behavioral: Score of anxiety questionnaire; Diagnostic Test: Heart rate; Diagnostic Test: Oxygen saturation | |
| Second dental visit | Dental anxiety level, heart rate and oxygen saturation of participants in second dental visit. Receives: Behavioral: Score of anxiety questionnaire; Diagnostic Test: Heart rate; Diagnostic Test: Oxygen saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the starting to study
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.
Measured: Before the starting to study
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.
Measured: Before the starting to dental treatment in first session.
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: Measured at the 5th, 10th and 15th minutes of dental treatment.
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: Measured at the 5th, 10th and 15th minutes of dental treatment.
Determination of dental anxiety score of participants after dental treatment in first dental session
All participants completed the dental anxiety questionnaire after treatment process.
Measured: After the dental treatment in first session.
Determination of dental anxiety score of participants before dental treatment in second dental session
All participants completed the dental anxiety questionnaire before starting treatment.
Measured: Before the starting to dental treatment in second session.
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: Measured at the 5th, 10th and 15th minutes of dental treatment.
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: Measured at the 5th, 10th and 15th minutes of dental treatment.
Determination of dental anxiety score of participants after dental treatment in second dental session
All participants completed the dental anxiety questionnaire after treatment process.
Measured: After the dental treatment in second session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start5 Aug 2023
- Primary completion3 Nov 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamit Tunc, Burdur Mehmet Akif Ersoy University
- Investigators
- Hamit Tunç, Ph.D, Principal investigator, Burdur Mehmet Akif Ersoy University Faculty of Dentistry Deparment of Paediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266156
- Sponsor's protocol ID
- BMU-HTUNC-01
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Consecutive Dental Visits on Dental Anxiety of Paediatric Patients
- ClinicalTrials.gov ID
- NCT06266156
- Acronym / sponsor ID
- BMU-HTUNC-01
- Conditions
- Dental Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Firts Dental Visit | – | Behavioral: Score of anxiety questionnaire, Diagnostic Test: Heart rate, Diagnostic Test: Oxygen saturationDental anxiety level, heart rate and oxygen saturation of participants in first dental visit. |
| Second dental visit | – | Behavioral: Score of anxiety questionnaire, Diagnostic Test: Heart rate, Diagnostic Test: Oxygen saturationDental anxiety level, heart rate and oxygen saturation of participants in second dental visit. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 6-9 years who meet the inclusion criteria and needed at least two restorative dental treatments of the mandibular first primary molar were included in the study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Score of anxiety questionnaireAll participants were answered the dental anxiety questionnaire. | Behavioural | Firts Dental Visit, Second dental visit |
| Heart rateAll participants heart rate were measured with finger type pulse oxymeter. | Diagnostic test | Firts Dental Visit, Second dental visit |
| Oxygen saturationAll participants oxygen saturation were measured with finger type pulse oxymeter. | Diagnostic test | Firts Dental Visit, Second dental visit |
Primary outcome
Determination of sample size.
Time frame: Before the starting to study
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.
Inviting participants to the study.
Time frame: Before the starting to 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.
Determination of dental anxiety score of participants before dental treatment in first dental session
Time frame: Before the starting to dental treatment in first 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.
Heart rate measuring in first dental session.
Time frame: Measured at the 5th, 10th and 15th minutes of dental treatment.
The heart rate were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.
Oxygen saturation measuring in first dental session.
Time frame: Measured at the 5th, 10th and 15th minutes of dental treatment.
The oxygen saturation were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.
Determination of dental anxiety score of participants after dental treatment in first dental session
Time frame: After the dental treatment in first session.
All participants completed the dental anxiety questionnaire after treatment process.
Determination of dental anxiety score of participants before dental treatment in second dental session
Time frame: Before the starting to dental treatment in second session.
All participants completed the dental anxiety questionnaire before starting treatment.
Heart rate measuring in second dental session.
Time frame: Measured at the 5th, 10th and 15th minutes of dental treatment.
The heart rate were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.
Oxygen saturation measuring in second dental session.
Time frame: Measured at the 5th, 10th and 15th minutes of dental treatment.
The oxygen saturation were measured in every 5 minutes during dental procedures. Total dental treatment time 15 minutes.
Determination of dental anxiety score of participants after dental treatment in second dental session
Time frame: After the dental treatment in second session.
All participants completed the dental anxiety questionnaire after treatment process.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamit Tunç, Ph.D principal investigator
Burdur Mehmet Akif Ersoy University Faculty of Dentistry Deparment of Paediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of sample size. (time frame: Before the starting to study). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.