NCT06484998

Brief 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. 1.Is there a relationship between children's compomer restoration colour preferences and dental anxiety?
  2. 2.Do children's compomer restoration colour preferences vary according to age and gender?
  3. 3.Are children's compomer restoration colour preferences the same as their favourite colours?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

June 26, 2024

Last Update Submit

July 2, 2024

Conditions

Keywords

ColourCompomerDental AnxietyDental CariesPrimary teeth

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    before dental treatment to 30 minutes

Study Arms (3)

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.

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.

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.

Behavioral: Dental anxiety level and child's compomer colors selection

Interventions

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.

high anxietylow anxietymoderate anxiety

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • the child must be between 5-10 years old
  • who needed restorative treatment of their deciduous molars
  • no systemic disease or syndrome

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bülent Ecevit Univercity

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Edanur 1 çakır

    Bülent Ecevit University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

January 1, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations