Dental AnxietyNCT05125731
Effect of Parental Absence on Child's Dental Anxiety and Behaviors During Dental Treatment
A study testing Parental absence, Parental visual support and Parental presence in people with Dental Anxiety and Children, Only, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The basis of pediatric dentistry is to provide cooperation in children with various behavioral management techniques. The presence or absence of the parent during dental treatments can be used to ensure the child's compliance with the treatment. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Children, Only, Dental Caries
- What is being tested?
- Parental absence, Parental visual support and Parental presence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Apr 2022
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- No previous dental treatment experience
- No need for urgent dental treatment
- Presence of at least one interproximal carious lesion in a primary molar tooth with a lesion depth does not exceeding 1/2 of the inner dentin radiographically and without irreversible pulp pathology
Who cannot join
- Any systemic disease, physical or mental disorder
- Uncooperative child who absolutely refuses dental treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University Faculty of Dentistry
Ankara
About this study
Official title: Evaluation of the Effect of Parental Absence on Child's Dental Anxiety and Behaviors During Dental Treatment: A Randomized Controlled Trial
The basis of pediatric dentistry is to provide cooperation in children with various behavioral management techniques. The presence or absence of the parent during dental treatments can be used to ensure the child's compliance with the treatment.
The aim of this study is to investigate the effect of the presence or absence of the parent on the child's dental anxiety and child's behavior during dental treatment. The secondary aim is to examine the relationship between the child's dental fear and the parent's dental fear.
Read more
Healthy children between the ages of 4-7, who have no dental experience and need restorative treatment will be included in the study. Participants will be randomly assigned to one of three study groups (Group 1: Parental absence, Group 2: Parent behind a barrier and Group 3: Parental presence).
Psychometric and projective tests will be applied to assess child's and parent's dental anxiety at the beginning of the study.
At the second appointment scheduled for the operative treatment of decayed primary molar tooth, first the child will be administered topical and local anesthesia, a rubber dam will be placed on the decayed tooth, the caries will be removed with high and low speed rotary instruments and the cavity will be restored with a compomer filling.
Children's heart rates and blood oxygen saturation will be measured by a pulse oximeter during treatment in order to evaluate dental anxiety. Children will be videotaped during treatment so that their behaviour can be evaluated later by another researcher.
After treatment, psychometric and projective tests used to measure the child's dental anxiety will be re-administered.
Read the detailed description
The aim of this clinical study is:
- to determine the presence or absence of the parent during the treatment in order to ensure the cooperation of the child during the dental treatment
- to investigate the relationship between the parent's dental fear and the child's dental fear 72 healthy children aged 4-7 will be recruited from Ankara Yıldırım Beyazıt University Faculty of Dentistry, Department of Pediatric Dentistry outpatient clinic.
Participants who met the inclusion criteria and agreed to participate will be randomly allocated to Group 1 (Parental absence), Group 2 (Parent behind a barrier) or Group 3 (Parental presence).
A simple randomization method will be used with opaque sealed envelopes containing "Group 1", "Group 2" or "Group 3" prepared separately for 4 different ages (4, 5, 6 and 7) in the study. Group allocation will be performed by an independent researcher, not involved in the study.
"Venham Picture Test" and "The Dental Subscale of the Children's Fear Survey Schedule" questionnaire will be applied to the children before and after the dental treatments.
The parent's dental anxiety will be measured with "The Corah Dental Anxiety Scale" and parent's attitude will be measured with "Parental Attitude Scale".
During the dental treatments the heart rate and the blood oxygen saturation of each participant will be recorded at 30-second intervals. The mean number of these measurements will be calculated for each of the following processes.
- Sitting in the dental chair at the beginning of the treatment
- Administration of topical anesthesia
- Administration of local anesthesia
- Caries removal with high-speed rotary instrument
- Caries removal with low-speed rotary instrument
- Application of dental matrix
- Placement of dental filling material
- Restoration finishing and polishing
- Sitting in the dental chair at the end of the treatment
Video recordings taken during dental treatment will be watched later by a dentist who is blind to the treatment groups and the child's cooperation during treatment will be recorded using the Frankl behavioral scale.
- Conditions
- Dental Anxiety, Children, Only, Dental Caries
- Being tested
- Parental absence, Parental visual support, Parental presence
- Keywords
- Behaviour management, Dental fear, Parental absence
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental absenceBehavioural
Parent does not accompany the child during dental treatment
Parental visual supportBehavioural
The parent does not accompany the child during the dental treatment but watches behind the glass and is seen by the child.
Parental presenceBehavioural
Parent accompanies the child during dental treatment
| Study group | Role | What they receive |
|---|---|---|
| Parental absence | Experimental | The parent will not be present in the dental clinic during the treatment. Parents will be instructed to wait in a waiting room outside the clinic, out of sight of the child. Receives: Behavioral: Parental absence |
| Parental visual support | Active comparator | The parent will watch and wait behind a transparent barrier without disrupting the interaction between the dentist and the child. This type of separation differs from the total absence of the parent because the parent is within the child's sight. Receives: Behavioral: Parental visual support |
| Parental presence | Active comparator | One of the parents will accompany the child during the dental treatment. The parent is allowed to sit next to the child without disturbing the interaction between the dentist and the child. Receives: Behavioral: Parental presence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in children's dental anxiety scores on Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) at the end of the dental treatment.
The CFSS-DS is a 15-item questionnaire on various aspects of dental treatment. Each item can be given five different scores ranging from "not afraid at all (1)" to "very much afraid (5)." The CFSS-DS has a total score range of 15 to 75 and a score of 38 or more has been associated with clinical dental fear.
Measured: 1. At the first visit- immediately after being assigned to one of the three study arms; 2. At the second visit- within 30 min after dental treatment
Mean change from baseline in children's dental anxiety scores on Venham Picture Test at the end of the dental treatment.
The Venham picture test is comprised of 8 pairs of images, where each pair represents one anxious figure and one non-anxious figure. The children are asked to select the ones that reflect their emotional state best. The anxious figure gets 1 point, and the non-anxious figure gets 0 points. The final score ranges from 0 (least anxious) to 8 (most anxious).
Measured: 1. At the first visit- immediately after being assigned to one of the three study arms; 2. At the second visit- within 30 min after dental treatment
Heart rate measurement to assess dental anxiety
Measurement will be made with a pulse oximeter
Measured: during dental treatment
Blood oxygen saturation measurement to assess dental anxiety
Measurement will be made with a pulse oximeter
Measured: during dental treatment
Frankl behavioral scale to measure compliance to dental treatment
Frankl behavior scale classifies child behavior into four categories (1-definitely negative 2- negative, 3- positive and 4- definitely positive) according to the child's attitude during dental treatment.
The video recording taken during the treatment will be evaluated by another researcher. In the "parental presence group" where the parent accompanies the child, the parent will be seated outside the camera's field of view.
Measured: during dental treatment
Secondary outcomes (1)
The Corah Dental Anxiety Scale to measure the parent's dental anxiety
The Corah Dental Anxiety Scale (DAS) is a 4-item questionnaire related to various aspects of dental treatment (Anticipating visit to the dental clinic, waiting in the dentist's office for treatment, waiting in the dental chair for drilling of teeth, waiting in the dental chair for scaling the teeth).
Each item contains 5 possible answers. Each answer has an assigned numeric value (1-5). The sum of the values assigned for each response is the result of the test and can vary from 4 to 20 points. A score less than 9 indicates low dental anxiety. A score of 9-12 points indicates moderate dental anxiety.A score of 13-14 points indicates high dental anxiety. A score of 15-20 points indicates very high dental anxiety.
Measured: At the first visit- immediately after being assigned to one of the three study arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Oct 2021
- Primary completion1 Jan 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYŞE IŞIL CİHAN, Ankara Yildirim Beyazıt University
- Investigators
- Ayse I. Orhan, Assoc. Prof., Study chair, Ankara Yıldırım Beyazit University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125731
- Sponsor's protocol ID
- E2-21-738
- Status last verified
- Oct 2025
- First submitted
- 26 Oct 2021
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gustafsson A, Broberg A, Bodin L, Berggren U, Arnrup K. Dental behaviour management problems: the role of child personal characteristics. Int J Paediatr Dent. 2010 Jul;20(4):242-53. doi: 10.1111/j.1365-263X.2010.01046.x.
PubMed 20536585Kantaputra PN, Chiewcharnvalijkit K, Wairatpanich K, Malikaew P, Aramrattana A. Children's attitudes toward behavior management techniques used by dentists. J Dent Child (Chic). 2007 Jan-Apr;74(1):4-9.
PubMed 18430348Versloot J, Veerkamp J, Hoogstraten J. Dental anxiety and psychological functioning in children: its relationship with behaviour during treatment. Eur Arch Paediatr Dent. 2008 Feb;9 Suppl 1:36-40. doi: 10.1007/BF03262654.
PubMed 18328247Klingberg G, Berggren U, Noren JG. Dental fear in an urban Swedish child population: prevalence and concomitant factors. Community Dent Health. 1994 Dec;11(4):208-14.
PubMed 7850639Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9. doi: 10.14219/jada.archive.1978.0394.
PubMed 31377Venham LL, Gaulin-Kremer E. A self-report measure of situational anxiety for young children. Pediatr Dent. 1979 Jun;1(2):91-6. No abstract available.
PubMed 399677Cuthbert MI, Melamed BG. A screening device: children at risk for dental fears and management problems. ASDC J Dent Child. 1982 Nov-Dec;49(6):432-6. No abstract available.
PubMed 6960031Frankl SN, Shiere FR, Fogels HR. Should the parent remain with the child in the dental operatory? J Dent Child 1962; 29: 150-163.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Parental Absence on Child's Dental Anxiety and Behaviors During Dental Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05125731
- Acronym / sponsor ID
- E2-21-738
- Conditions
- Dental Anxiety, Children, Only, Dental Caries
- Keywords
- Behaviour management, Dental fear, Parental absence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 18 Nov 2021 (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.
The basis of pediatric dentistry is to provide cooperation in children with various behavioral management techniques. The presence or absence of the parent during dental treatments can be used to ensure the child's compliance with the treatment.
The aim of this study is to investigate the effect of the presence or absence of the parent on the child's dental anxiety and child's behavior during dental treatment. The secondary aim is to examine the relationship between the child's dental fear and the parent's dental fear.
Healthy children between the ages of 4-7, who have no dental experience and need restorative treatment will be included in the study. Participants will be randomly assigned to one of three study groups (Group 1: Parental absence, Group 2: Parent behind a barrier and Group 3: Parental presence).
Psychometric and projective tests will be applied to assess child's and parent's dental anxiety at the beginning of the study.
At the second appointment scheduled for the operative treatment of decayed primary molar tooth, first the child will be administered topical and local anesthesia, a rubber dam will be placed on the decayed tooth, the caries will be removed with high and low speed rotary instruments and the cavity will be restored with a compomer filling.
Children's heart rates and blood oxygen saturation will be measured by a pulse oximeter during treatment in order to evaluate dental anxiety. Children will be videotaped during treatment so that their behaviour can be evaluated later by another researcher.
After treatment, psychometric and projective tests used to measure the child's dental anxiety will be re-administered.
Detailed description
The aim of this clinical study is:
- to determine the presence or absence of the parent during the treatment in order to ensure the cooperation of the child during the dental treatment
- to investigate the relationship between the parent's dental fear and the child's dental fear 72 healthy children aged 4-7 will be recruited from Ankara Yıldırım Beyazıt University Faculty of Dentistry, Department of Pediatric Dentistry outpatient clinic.
Participants who met the inclusion criteria and agreed to participate will be randomly allocated to Group 1 (Parental absence), Group 2 (Parent behind a barrier) or Group 3 (Parental presence).
A simple randomization method will be used with opaque sealed envelopes containing "Group 1", "Group 2" or "Group 3" prepared separately for 4 different ages (4, 5, 6 and 7) in the study. Group allocation will be performed by an independent researcher, not involved in the study.
"Venham Picture Test" and "The Dental Subscale of the Children's Fear Survey Schedule" questionnaire will be applied to the children before and after the dental treatments.
The parent's dental anxiety will be measured with "The Corah Dental Anxiety Scale" and parent's attitude will be measured with "Parental Attitude Scale".
During the dental treatments the heart rate and the blood oxygen saturation of each participant will be recorded at 30-second intervals. The mean number of these measurements will be calculated for each of the following processes.
- Sitting in the dental chair at the beginning of the treatment
- Administration of topical anesthesia
- Administration of local anesthesia
- Caries removal with high-speed rotary instrument
- Caries removal with low-speed rotary instrument
- Application of dental matrix
- Placement of dental filling material
- Restoration finishing and polishing
- Sitting in the dental chair at the end of the treatment
Video recordings taken during dental treatment will be watched later by a dentist who is blind to the treatment groups and the child's cooperation during treatment will be recorded using the Frankl behavioral scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parental absence | Experimental | Behavioral: Parental absenceThe parent will not be present in the dental clinic during the treatment. Parents will be instructed to wait in a waiting room outside the clinic, out of sight of the child. |
| Parental visual support | Active comparator | Behavioral: Parental visual supportThe parent will watch and wait behind a transparent barrier without disrupting the interaction between the dentist and the child. This type of separation differs from the total absence of the parent because the parent is within the child's sight. |
| Parental presence | Active comparator | Behavioral: Parental presenceOne of the parents will accompany the child during the dental treatment. The parent is allowed to sit next to the child without disturbing the interaction between the dentist and the child. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- No previous dental treatment experience
- No need for urgent dental treatment
- Presence of at least one interproximal carious lesion in a primary molar tooth with a lesion depth does not exceeding 1/2 of the inner dentin radiographically and without irreversible pulp pathology
Key exclusion criteria (2 listed)
- Any systemic disease, physical or mental disorder
- Uncooperative child who absolutely refuses dental treatment
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 |
|---|---|---|
| Parental absenceParent does not accompany the child during dental treatment | Behavioural | Parental absence |
| Parental visual supportThe parent does not accompany the child during the dental treatment but watches behind the glass and is seen by the child. | Behavioural | Parental visual support |
| Parental presenceParent accompanies the child during dental treatment | Behavioural | Parental presence |
Primary outcome
Mean change from baseline in children's dental anxiety scores on Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) at the end of the dental treatment.
Time frame: 1. At the first visit- immediately after being assigned to one of the three study arms; 2. At the second visit- within 30 min after dental treatment
The CFSS-DS is a 15-item questionnaire on various aspects of dental treatment. Each item can be given five different scores ranging from "not afraid at all (1)" to "very much afraid (5)." The CFSS-DS has a total score range of 15 to 75 and a score of 38 or more has been associated with clinical dental fear.
Mean change from baseline in children's dental anxiety scores on Venham Picture Test at the end of the dental treatment.
Time frame: 1. At the first visit- immediately after being assigned to one of the three study arms; 2. At the second visit- within 30 min after dental treatment
The Venham picture test is comprised of 8 pairs of images, where each pair represents one anxious figure and one non-anxious figure. The children are asked to select the ones that reflect their emotional state best. The anxious figure gets 1 point, and the non-anxious figure gets 0 points. The final score ranges from 0 (least anxious) to 8 (most anxious).
Heart rate measurement to assess dental anxiety
Time frame: during dental treatment
Measurement will be made with a pulse oximeter
Blood oxygen saturation measurement to assess dental anxiety
Time frame: during dental treatment
Measurement will be made with a pulse oximeter
Frankl behavioral scale to measure compliance to dental treatment
Time frame: during dental treatment
Frankl behavior scale classifies child behavior into four categories (1-definitely negative 2- negative, 3- positive and 4- definitely positive) according to the child's attitude during dental treatment. The video recording taken during the treatment will be evaluated by another researcher. In the "parental presence group" where the parent accompanies the child, the parent will be seated outside the camera's field of view.
1 secondary outcome
The Corah Dental Anxiety Scale to measure the parent's dental anxiety
Time frame: At the first visit- immediately after being assigned to one of the three study arms
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 6 Oct 2025.
- Background: PubMed 20536585Gustafsson A, Broberg A, Bodin L, Berggren U, Arnrup K. Dental behaviour management problems: the role of child personal characteristics. Int J Paediatr Dent. 2010 Jul;20(4):242-53. doi: 10.1111/j.1365-263X.2010.01046.x.
- Background: PubMed 18430348Kantaputra PN, Chiewcharnvalijkit K, Wairatpanich K, Malikaew P, Aramrattana A. Children's attitudes toward behavior management techniques used by dentists. J Dent Child (Chic). 2007 Jan-Apr;74(1):4-9.
- Background: PubMed 18328247Versloot J, Veerkamp J, Hoogstraten J. Dental anxiety and psychological functioning in children: its relationship with behaviour during treatment. Eur Arch Paediatr Dent. 2008 Feb;9 Suppl 1:36-40. doi: 10.1007/BF03262654.
- Background: PubMed 7850639Klingberg G, Berggren U, Noren JG. Dental fear in an urban Swedish child population: prevalence and concomitant factors. Community Dent Health. 1994 Dec;11(4):208-14.
- Background: PubMed 31377Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9. doi: 10.14219/jada.archive.1978.0394.
- Background: PubMed 399677Venham LL, Gaulin-Kremer E. A self-report measure of situational anxiety for young children. Pediatr Dent. 1979 Jun;1(2):91-6. No abstract available.
- Background: PubMed 6960031Cuthbert MI, Melamed BG. A screening device: children at risk for dental fears and management problems. ASDC J Dent Child. 1982 Nov-Dec;49(6):432-6. No abstract available.
- BackgroundFrankl SN, Shiere FR, Fogels HR. Should the parent remain with the child in the dental operatory? J Dent Child 1962; 29: 150-163.
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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.
Ayse I. Orhan, Assoc. Prof. study chair
Ankara Yıldırım Beyazit University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental absence, Parental visual support and Parental presence in people with Dental Anxiety and Children, Only, run by Ankara Yildirim Beyazıt 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 3 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 6 Oct 2025. 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?
Mean change from baseline in children's dental anxiety scores on Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) at the end of the dental treatment. (time frame: 1. At the first visit- immediately after being assigned to one of the three study arms; 2. At the second visit- within 30 min after dental treatment). The study lists 5 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 NCT05125731, which also lists 8 linked publications.
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 6 Oct 2025.