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).
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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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.
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.
- Conditions
- Dental Anxiety, Periodontal Health, Oral Hygiene
- 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 group | Role | What they receive |
|---|---|---|
| anxious group | Children with a score ≥4 on the venham picture test were included. Receives: Behavioral: dental anxiety and oral hygiene | |
| non-anxious group | Children 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.
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)
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.
- First posted3 Oct 2022
- Study start1 Dec 2019
- Primary completion1 Apr 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin Besiroglu, Okan University
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maternal Dental Anxiety and Oral Hygiene Status on the Dental Anxiety and Periodontal Health of Their Children
- ClinicalTrials.gov ID
- NCT05563532
- Acronym / sponsor ID
- 2019/104.25
- Conditions
- Dental Anxiety, Periodontal Health, Oral Hygiene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 3 Oct 2022 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anxious group | – | Behavioral: dental anxiety and oral hygieneChildren with a score ≥4 on the venham picture test were included. |
| non-anxious group | – | –Children with a score <4 on the venham picture test were included. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- The exclusion criteria for children were defined as having systemic disease,
- Having reported acute pain.
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 and oral hygieneEvaluation of the effect of mothers' dental anxiety and oral hygiene on children's dental anxiety and periodontal status. | Behavioural | anxious group |
Primary outcome
Evaluation of the child's dental anxiety level
Time frame: 2 years
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.
1 secondary outcome
Evaluation of the mother's dental anxiety level
Time frame: 2 years
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 Oct 2022.
- Derived from this study: PubMed 38943136Besiroglu-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.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.