Dental AnxietyNCT06484998
Relationship Between Children's Colour Preferences and Their Dental Anxiety
A study testing Dental anxiety level and child's compomer colors selection in people with Dental Anxiety and Child Development, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study was to examine the relationship between children's color preferences and their dental anxiety. It aims to answer are: 1. Is there a relationship between children's compomer restoration colour preferences and dental anxiety? 2. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Child Development
- What is being tested?
- Dental anxiety level and child's compomer colors selection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jan 2024
- Phase
- Interventional
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- the child must be between 5-10 years old
- who needed restorative treatment of their deciduous molars
- no systemic disease or syndrome
Who cannot join
- the child is under 5 years old and over 10 years old
- who not needed restorative treatment of deciduous molars and haven't those teeth
- having any systemic disease or syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bülent Ecevit Univercity
Zonguldak, Kozlu, 67600
About this study
Official title: Evaluation Of The Relationship Between Dental Anxiety Levels Of Children And Their Compomer Restoration Colour Preferences
The objective of this study was to examine the relationship between children's color preferences and their dental anxiety. It aims to answer are:
- Is there a relationship between children's compomer restoration colour preferences and dental anxiety?
- Do children's compomer restoration colour preferences vary according to age and gender?
- Are children's compomer restoration colour preferences the same as their favourite colours?
Read the detailed description
Background: Dental fear and anxiety, which are frequently encountered in children, are recognised as an important public health problem in many countries and this situation leads to postponement and neglect of dental treatments. The aim of this study is to evaluate the relationship between colored compomer color preferences and dental anxiety levels, which are frequently used in the restorative treatments of pediatric patients who need restorative treatment of primary molar teeth.
Methods: In this study, the relationship between anxiety levels and compomer restoration color preferences was evaluated in 275 patients aged between 5 and 10 years who required restorative treatment in primary molar teeth. Children's dental anxiety levels were determined using the Modified Child Dental Anxiety Scale, face version (MCDAS-f). Children with identified anxiety levels were asked to choose colors for their fillings. A scale consisting of 9 colors (pink, blue, gold, silver, orange, yellow, green, purple, white) was used for color selection by adding white to the colored compomer scale.
- Conditions
- Dental Anxiety, Child Development
- Being tested
- Dental anxiety level and child's compomer colors selection
- Keywords
- Colour, Compomer, Dental Anxiety, Dental Caries, Primary teeth
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental anxiety level and child's compomer colors selectionBehavioural
Patients without any syndromes or systemic disorders, without mental retardation, who needed restorative treatment for primary molars were included in the study. The examination forms of 275 patients requiring restorative treatment of primary teeth were analysed at the session they came for restorative treatment. To determine the child's anxiety, the Modified Child Dental Anxiety Scale-faces version was administered to the children before restorative treatment. The children were asked to choose from a scale consisting of 9 colours (pink, blue, gold, silver, orange, yellow, green, purple, white) for the compomer restoration color selections. The patients were asked what their favourite color was after the compomer restoration color selection so that the previous question would not have any effect on the child's restoration color selection.
| Study group | Role | What they receive |
|---|---|---|
| low anxiety | Experimental | A score was obtained from the MCDASf scale by summing the scores of each question expressed with faces ranging from 1 "relaxed", 2 "slightly worried", 3 "worried", 4 "very worried" and 5 "extremely worried" according to the 8 questions. Those with a total score of less than 19 points were included in this group. Receives: Behavioral: Dental anxiety level and child's compomer colors selection |
| moderate anxiety | Experimental | A score was obtained from the MCDASf scale by summing the scores of each question expressed with faces ranging from 1 "relaxed", 2 "slightly worried", 3 "worried", 4 "very worried" and 5 "extremely worried" according to the 8 questions. Those with a total score between 19-31 points were included in this group. Receives: Behavioral: Dental anxiety level and child's compomer colors selection |
| high anxiety | Experimental | A score was obtained from the MCDASf scale by summing the scores of each question expressed with faces ranging from 1 "relaxed", 2 "slightly worried", 3 "worried", 4 "very worried" and 5 "extremely worried" according to the 8 questions. Those with a total score between 32-40 points were included in this group. Receives: Behavioral: Dental anxiety level and child's compomer colors selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety level
To determine the child's anxiety, the Modified Child Dental Anxiety Scale-faces version(MCDAS f) was administered to the children before restorative treatment. According to the MCDASf, a score was obtained by summing the scores of each question expressed with faces ranging from 1 "relaxed", 2 "slightly anxious", 3 "anxious", 4 "very anxious" and 5 "extremely anxious" according to 8 questions. A total score of less than 19 points was categorised as low anxiety, 19-31 points as moderate anxiety and 32-40 points as high anxiety.
Measured: before dental treatment to 30 minutes
colour preference
The children were asked to choose from a new scale consisting of 9 colours (pink, blue, gold, silver, orange, yellow, green, purple, white) by adding white compomer (Dyract XP) to the colored compomer colour scale (Voco Twinky Star) for the compomer restoration color selections. During the color selection of the patients, it was ensured that the patients saw all the colors at the same time in order not to cause any guidance.
Measured: before dental treatment to 30 minutes
favorite color
The patients were asked what their favourite color was after the compomer restoration color selection so that the previous question would not have any effect on the child's restoration color selection and the data obtained were recorded.
Measured: before dental treatment to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Belevcikli, Bulent Ecevit University
- Investigators
- Edanur 1 çakır, Principal investigator, Bülent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484998
- Sponsor's protocol ID
- Bülent Ecevit University
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Relationship Between Dental Anxiety Levels Of Children And Their Compomer Restoration Colour Preferences
- ClinicalTrials.gov ID
- NCT06484998
- Acronym / sponsor ID
- Bülent Ecevit University
- Conditions
- Dental Anxiety, Child Development
- Keywords
- Colour, Compomer, Dental Anxiety, Dental Caries, Primary teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 3 Jul 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 objective of this study was to examine the relationship between children's color preferences and their dental anxiety. It aims to answer are:
- Is there a relationship between children's compomer restoration colour preferences and dental anxiety?
- Do children's compomer restoration colour preferences vary according to age and gender?
- Are children's compomer restoration colour preferences the same as their favourite colours?
Detailed description
Background: Dental fear and anxiety, which are frequently encountered in children, are recognised as an important public health problem in many countries and this situation leads to postponement and neglect of dental treatments. The aim of this study is to evaluate the relationship between colored compomer color preferences and dental anxiety levels, which are frequently used in the restorative treatments of pediatric patients who need restorative treatment of primary molar teeth.
Methods: In this study, the relationship between anxiety levels and compomer restoration color preferences was evaluated in 275 patients aged between 5 and 10 years who required restorative treatment in primary molar teeth. Children's dental anxiety levels were determined using the Modified Child Dental Anxiety Scale, face version (MCDAS-f). Children with identified anxiety levels were asked to choose colors for their fillings. A scale consisting of 9 colors (pink, blue, gold, silver, orange, yellow, green, purple, white) was used for color selection by adding white to the colored compomer scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low anxiety | Experimental | Behavioral: Dental anxiety level and child's compomer colors selectionA score was obtained from the MCDASf scale by summing the scores of each question expressed with faces ranging from 1 "relaxed", 2 "slightly worried", 3 "worried", 4 "very worried" and 5 "extremely worried" according to the 8 questions. Those with a total score of less than 19 points were included in this group. |
| moderate anxiety | Experimental | Behavioral: Dental anxiety level and child's compomer colors selectionA score was obtained from the MCDASf scale by summing the scores of each question expressed with faces ranging from 1 "relaxed", 2 "slightly worried", 3 "worried", 4 "very worried" and 5 "extremely worried" according to the 8 questions. Those with a total score between 19-31 points were included in this group. |
| high anxiety | Experimental | Behavioral: Dental anxiety level and child's compomer colors selectionA score was obtained from the MCDASf scale by summing the scores of each question expressed with faces ranging from 1 "relaxed", 2 "slightly worried", 3 "worried", 4 "very worried" and 5 "extremely worried" according to the 8 questions. Those with a total score between 32-40 points were included in this group. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- the child must be between 5-10 years old
- who needed restorative treatment of their deciduous molars
- no systemic disease or syndrome
Key exclusion criteria (3 listed)
- the child is under 5 years old and over 10 years old
- who not needed restorative treatment of deciduous molars and haven't those teeth
- having any systemic disease or syndrome
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 |
|---|---|---|
| Dental anxiety level and child's compomer colors selectionPatients without any syndromes or systemic disorders, without mental retardation, who needed restorative treatment for primary molars were included in the study. The examination forms of 275 patients requiring restorative treatment of primary teeth were analysed at the session they came for restorative treatment. To determine the child's anxiety, the Modified Child Dental Anxiety Scale-faces version was administered to the children before restorative treatment. The children were asked to choose from a scale consisting of 9 colours (pink, blue, gold, silver, orange, yellow, green, purple, white) for the compomer restoration color selections. The patients were asked what their favourite color was after the compomer restoration color selection so that the previous question would not have any effect on the child's restoration color selection. | Behavioural | high anxiety, low anxiety, moderate anxiety |
Primary outcome
anxiety level
Time frame: before dental treatment to 30 minutes
To determine the child's anxiety, the Modified Child Dental Anxiety Scale-faces version(MCDAS f) was administered to the children before restorative treatment. According to the MCDASf, a score was obtained by summing the scores of each question expressed with faces ranging from 1 "relaxed", 2 "slightly anxious", 3 "anxious", 4 "very anxious" and 5 "extremely anxious" according to 8 questions. A total score of less than 19 points was categorised as low anxiety, 19-31 points as moderate anxiety and 32-40 points as high anxiety.
colour preference
Time frame: before dental treatment to 30 minutes
The children were asked to choose from a new scale consisting of 9 colours (pink, blue, gold, silver, orange, yellow, green, purple, white) by adding white compomer (Dyract XP) to the colored compomer colour scale (Voco Twinky Star) for the compomer restoration color selections. During the color selection of the patients, it was ensured that the patients saw all the colors at the same time in order not to cause any guidance.
favorite color
Time frame: before dental treatment to 30 minutes
The patients were asked what their favourite color was after the compomer restoration color selection so that the previous question would not have any effect on the child's restoration color selection and the data obtained were recorded.
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 3 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Dental Anxiety
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
Bruxism, Anxiety
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Active, not recruiting
Musical Intervention for Dental Anxiety
Dental Anxiety
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.
Edanur 1 çakır principal investigator
Bülent Ecevit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental anxiety level and child's compomer colors selection in people with Dental Anxiety and Child Development, run by Bulent Ecevit 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 3 inclusion and 3 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 3 Jul 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?
anxiety level (time frame: before dental treatment to 30 minutes). The study lists 3 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 3 Jul 2024.