- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06484998
Relationship Between Children's Colour Preferences and Their Dental Anxiety
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?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kozlu
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Zonguldak, Kozlu, Turkey, 67600
- Bülent Ecevit Univercity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- the child must be between 5-10 years old
- who needed restorative treatment of their deciduous molars
- no systemic disease or syndrome
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: low anxiety
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.
|
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.
|
|
Experimental: moderate anxiety
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.
|
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.
|
|
Experimental: high anxiety
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
before dental treatment to 30 minutes
|
|
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.
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before dental treatment to 30 minutes
|
|
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.
|
before dental treatment to 30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edanur 1 çakır, Bulent Ecevit University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bulent Ecevit University (Other Identifier: Bulent Ecevit University Human Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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