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Dental AnxietyNCT05563532

Dental Anxiety and Periodontal Health

An observational study of Dental Anxiety and Periodontal Health, run by Okan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mothers usually have the primary role in bringing up children and developing health-related behaviors. The aim of this study was to determine the effect of mothers' dental anxiety and oral hygiene on the dental anxiety and periodontal health of their children. Read more about this study

Who is it for?
Ages 4 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Dental Anxiety, Periodontal Health, Oral Hygiene
What is being tested?
dental anxiety and oral hygiene
How many people
280 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2019to 1 Sep 2022
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 4 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: The study inclusion criteria for mothers were the absence of any systemic and psychiatric disorders, not being pregnant or breastfeeding, non-smoking, not having received periodontal treatment in the last 6 months, and with at least 20 teeth and willing to participate in the study. The inclusion criteria for children were defined as age 4-12 years, having no known systemic disease, visiting a dentist for the first time, and not having reported acute pain. Only one child per family was included in the study for mother-child pairs.

Who may be able to join

  • The inclusion criteria for children were defined as age 4-12 years,
  • Having no known systemic disease,
  • visiting a dentist for the first time,
  • not having reported acute pain.

Who cannot join

  • The exclusion criteria for children were defined as having systemic disease,
  • Having reported acute pain.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Okan university

    Istanbul, Tuzla, 34947

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Maternal Dental Anxiety and Oral Hygiene Status on the Dental Anxiety and Periodontal Health of Their Children

Mothers usually have the primary role in bringing up children and developing health-related behaviors. The aim of this study was to determine the effect of mothers' dental anxiety and oral hygiene on the dental anxiety and periodontal health of their children.

The study included 280 randomly selected children, aged 4-12 years, who came to the dentist for the first time and their mothers. Demographic and oral hygiene information of the mothers was collected through a questionaire. Dental anxiety of the mothers and children was assessed using the Modified Dental Anxiety Scale (MDAS) and the Venham Picture Test (VPT), respectively.

Read the detailed description

Anxiety is a neurotic syndrome in which patients have difficulty in explaining internal restlessness, anxiety and fear reaching the level of panic, which causes physiological and behavioral disorders as a result of affecting motor tension and even autonomic hyperactivity. Anxiety and fear are frequently encountered in dentistry clinical practice in both adults and children. Dental anxiety is also defined as intense fear and anxiety that occurs as a result of the thought that patients will be harmed, that they will have an unknown operation outside their control, and because they have had previous negative dental treatment experiences.

Direct factors such as previous traumatic dental experiences, postoperative complications, age, gender, anxious temperament in childhood, and indirect factors such as the effect of family on the approach to dental treatment and sociodemographic factors have been reported to have an effect on the development of dental anxiety. Most early school-age children begin to imitate their parents as role models. Children in this age group internalize their mothers' values, attitudes and behaviors, since they usually spend more time with their mothers. It is thought that especially parents' dental anxiety may have an effect on their children's dental anxiety through modeling and knowledge.

Children with dental anxiety try every way to avoid dental treatment. The thought that patients will feel more pain than normal due to the anxiety they experience during dental treatments makes treatment difficult. Anxiety might lead to individuals discontinuing treatment, thereby worsening their dental health. As a result, necessary dental treatment becomes more time-consuming, invasive, and costly. At the same time, treatment anxiety impedes the clinical process, jeopardizes treatment results, and causes professional stress for dentists.

Dental anxiety is evaluated through projective tests, behavioral assessments, psychometric assessments, and physiological techniques. Behavioral assessment is based on the dentist or researchers scoring the behaviors visually. For this purpose, the Frankl Behavior Scale and the Yale Preoperative Anxiety Scale are used. Psychometric assessments are made with questionnaires, which are the most preferred because of their ease of application, and these are used to measure the anxiety of children or adults before dental treatment. At the present time, the Modified Dental Anxiety Scale (MDAS) is frequently used for adults, while the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) is used for children. Projective techniques also use pictures or narratives of objects that may cause anxiety and fear in young children. The Venham Picture Test (VPT) and Children's Dental Fear Picture Test are commonly used projective techniques. Physiological techniques measure anxiety-related parameters such as salivary cortisol level, blood pressure, and dorsal skin response. However, it is thought that the equipment used in this technique may increase anxiety, especially in children.

From a review of literature it can be seen that there are few studies conducted in Turkey which have evaluated the effect of the mother on the child's dental anxiety and oral hygiene. The aim of this study was to determine the effects of mothers' dental anxiety and oral hygiene on the dental anxiety and periodontal health of their children, using psychometric analysis and projective methods.

Being tested
dental anxiety and oral hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dental anxiety and oral hygieneBehavioural

    Evaluation of the effect of mothers' dental anxiety and oral hygiene on children's dental anxiety and periodontal status.

Study groups in NCT05563532
Study groupRoleWhat they receive
anxious groupChildren with a score ≥4 on the venham picture test were included.
Receives: Behavioral: dental anxiety and oral hygiene
non-anxious groupChildren with a score <4 on the venham picture test were included.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the child's dental anxiety level

    The Venham Picture Test (VPT) was applied to the children to determine dental anxiety levels. The VPT consists of eight illustrations of human figures expressing various emotional reactions. The child selects pictures to reflect their current emotions. Each picture of an anxious child is assigned a score of 1, and each picture of a non-anxious child is assigned a score of 0. The total score ranges from 0 to 8, with a high score indicating a high level of anxiety, and a score of ≥4 is evaluated as high level dental anxiety. The children were separated into two groups based on whether or not they were classified as anxious.

    Measured: 2 years

Secondary outcomes (1)
  1. Evaluation of the mother's dental anxiety level

    Modified Dental Anxiety Scale (MDAS) was applied to the mothers to determine dental anxiety levels. The MDAS consists of 5 items providing a total score ranging from 5 to 25 points. A MDAS score ≥19 is evaluated as a high level of dental anxiety.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start1 Dec 2019
  3. Primary completion1 Apr 2022
  4. Study completion1 Sep 2022

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05563532
Sponsor's protocol ID
2019/104.25
Status last verified
Sep 2022
First submitted
17 Sep 2022
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Besiroglu-Turgut E, Kayaalti-Yuksek S, Bulut M. Evaluation of the relationship between dental anxiety and oral health status of mothers and their children. BMC Oral Health. 2024 Jun 28;24(1):749. doi: 10.1186/s12903-024-04530-0.

    PubMed 38943136

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Anxiety and Periodontal Health, run by Okan 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 4 inclusion and 2 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 Oct 2022. 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?

Evaluation of the child's dental anxiety level (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05563532, which also lists 1 linked publication.

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 Oct 2022.

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