Dental AnxietyNCT05285722
Testing of Cognitive Behavioral Therapy Resource of Turkish Version
A study testing Cognitive Behavioral Therapy form for dental anxiety in people with Dental Anxiety, run by Altinbas University at 2 sites in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the cognitive behavioral therapy source of Turkish version of the 'message to dentist' (MTD) with children attending two dental settings. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Cognitive Behavioral Therapy form for dental anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Mar 2021to 4 Aug 2021
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having dental anxiety but not having negative experiences during dental treatment in childhood or adolescence
- Without any systemical and mental diasabilities
- Who volunteered to participate in the study and whose parental consent was obtained.
Who cannot join
- not have dental anxiety
- having any systemical or mental disability
- having negative experiences during dental treatment in childhood or adolescence
- and who did not volunteer to participate in the study and did not have parental consent for the study were excluded.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Altinbas University, Faculty of Dentistry
Istanbul, Bakirkoy, 34147
Altinba University Faculty of Dentistry
Istanbul, 34147
About this study
Official title: Adaptation and Testing of Cognitive Behavioral Therapy Resource of Turkish Version of ''Message to Dentist'' to Reduce Dental Anxiety in Children
This study aimed to evaluate the cognitive behavioral therapy source of Turkish version of the 'message to dentist' (MTD) with children attending two dental settings.
Read the detailed description
Children aged 5-16 years attending a dental faculty clinic and a private dental office were invited to complete the MTD form. Children were asked to report how worried they felt, their level of pain they anticipated and the actual level of pain they experienced on a scale of 1-10 (with 1 being the best outcome).
- Conditions
- Dental Anxiety
- Being tested
- Cognitive Behavioral Therapy form for dental anxiety
- Keywords
- dental anxiety, cognitive behavioral therapy, pediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy form for dental anxietyBehavioural
Message to Dentist form
| Study group | Role | What they receive |
|---|---|---|
| dental anxiety group | Other | Children,
* Aged 5-15 years
* Having dental anxiety but not having negative experiences during dental treatment in childhood or adolescence
* Without any systemical and mental diasabilities
* Who volunteered to participate in the study and whose parental consent was obtained. Receives: Behavioral: Cognitive Behavioral Therapy form for dental anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinic differences and dental anxiety
according to CBT form, it will be evaluated
Measured: 6 month
worry type of participants
according to Cognitive Behavioral Therapy form, it will be evaluated
Measured: 6 month
Gender anxiety differences
according to Cognitive Behavioral Therapy form, it will be evaluated
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start4 Mar 2021
- Primary completion4 May 2021
- Study completion4 Aug 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altinbas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliye Tugce Gurcan, Altinbas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285722
- Sponsor's protocol ID
- AltinbasU
- Status last verified
- Mar 2022
- First submitted
- 4 Feb 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Porritt J, Rodd H, Morgan A, Williams C, Gupta E, Kirby J, Creswell C, Newton T, Stevens K, Baker S, Prasad S, Marshman Z. Development and Testing of a Cognitive Behavioral Therapy Resource for Children's Dental Anxiety. JDR Clin Trans Res. 2017 Jan;2(1):23-37. doi: 10.1177/2380084416673798. Epub 2016 Nov 1.
PubMed 28879243
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Testing of Cognitive Behavioral Therapy Resource of Turkish Version of ''Message to Dentist'' to Reduce Dental Anxiety in Children
- ClinicalTrials.gov ID
- NCT05285722
- Acronym / sponsor ID
- AltinbasU
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, cognitive behavioral therapy, pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Altinbas UniversityUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 18 Mar 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.
This study aimed to evaluate the cognitive behavioral therapy source of Turkish version of the 'message to dentist' (MTD) with children attending two dental settings.
Detailed description
Children aged 5-16 years attending a dental faculty clinic and a private dental office were invited to complete the MTD form. Children were asked to report how worried they felt, their level of pain they anticipated and the actual level of pain they experienced on a scale of 1-10 (with 1 being the best outcome).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dental anxiety group | Other | Behavioral: Cognitive Behavioral Therapy form for dental anxietyChildren, * Aged 5-15 years * Having dental anxiety but not having negative experiences during dental treatment in childhood or adolescence * Without any systemical and mental diasabilities * Who volunteered to participate in the study and whose parental consent was obtained. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Having dental anxiety but not having negative experiences during dental treatment in childhood or adolescence
- Without any systemical and mental diasabilities
- Who volunteered to participate in the study and whose parental consent was obtained.
Key exclusion criteria (4 listed)
- not have dental anxiety
- having any systemical or mental disability
- having negative experiences during dental treatment in childhood or adolescence
- and who did not volunteer to participate in the study and did not have parental consent for the study were excluded.
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 |
|---|---|---|
| Cognitive Behavioral Therapy form for dental anxietyMessage to Dentist form | Behavioural | dental anxiety group |
Primary outcome
clinic differences and dental anxiety
Time frame: 6 month
according to CBT form, it will be evaluated
worry type of participants
Time frame: 6 month
according to Cognitive Behavioral Therapy form, it will be evaluated
Gender anxiety differences
Time frame: 6 month
according to Cognitive Behavioral Therapy form, it will be evaluated
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 31 Mar 2022.
- Background: PubMed 28879243Porritt J, Rodd H, Morgan A, Williams C, Gupta E, Kirby J, Creswell C, Newton T, Stevens K, Baker S, Prasad S, Marshman Z. Development and Testing of a Cognitive Behavioral Therapy Resource for Children's Dental Anxiety. JDR Clin Trans Res. 2017 Jan;2(1):23-37. doi: 10.1177/2380084416673798. Epub 2016 Nov 1.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy form for dental anxiety in people with Dental Anxiety, run by Altinbas University at 2 sites 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 4 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
clinic differences and dental anxiety (time frame: 6 month). 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?
On the ClinicalTrials.gov record for NCT05285722, 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 31 Mar 2022.