BehaviorPediatricsNCT06912789

Technological Contributions to Behavior Guidance Techniques

An observational study of Behavior and Child, run by Recep Tayyip Erdogan University Training and Research Hospital 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

This study aims to evaluate the effects of three different behavior guidance methods on children's dental anxiety and pain perception. Read more about this study

Who is it for?: Ages 6 to 8 yearsHealthy volunteers can take part
Conditions the study is for: Behavior, Child, Dental Anxiety
How many people: 63 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 3 Jan 2024to 10 Jan 2025
How long will I take part?: 6 Days
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 6 to 8 years
All sexes
Healthy volunteers accepted
Child

Study population: Pediatric population

Who may be able to join

the patients had no previous dental treatment,
were between ages 6 and 8 years, accepted treatment accompanied by parents,
scored 3 (positive) or 4 (definitely positive) on the Frankl behavior scale,
had no systemic disease,
did not need emergency dental treatment, one of the upper molars required pulpotomy followed by a Class II composite restoration,
had no mental or physical disabilities,
understood the commands, and whose parents agreed to participate in the study
signed the consent form.

Who cannot join

Patients who did not meet the inclusion criteria included those who needed other asymptomatic root canal treatment other than pulpotomy indication,
needed restorative treatment due to a history of dental trauma, those who did not want to be included voluntarily,
who cried during the procedure or left the treatment unfinished,
who were determined to be negative (2) or definitely negative (1) according to the Frankl behavior assessment scale.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Recep Tayyip Erdoğan University Faculty of Dentistry
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Other trials in Turkey (Türkiye)

About this study

Official title: Are Technological Contributions in Behavior Guidance Techniques Superior to Conventional Methods? : Effects on Dental Anxiety and Pain Perception in Pulpotomy Treatment

This study aims to evaluate the effects of three different behavior guidance methods on children's dental anxiety and pain perception.

Read the detailed description

This study will include 63 children aged 6-8 years who will require pulpotomy followed by a Class II composite restoration and will be divided into three groups: tell-show-do (TSD; Group 1), TSD with video modeling (Group 2), and TSD with a mobile phone application (Group 3). Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and hemoglobin oxygen saturation (SPO2) of the participants will be recorded before the procedure, after local anesthesia, after pulpotomy, and at the end of the procedure. Faces Version of the Modified Child Dental Anxiety Scale (MCDAS f), Wong-Baker Faces Pain Rating Scale (WBFPRS), and Face, Legs, Activity, Cry, Consolability (FLACC) pain scales will be applied.

Conditions: Behavior, Child, Dental Anxiety, Mobile Applications, Pain
Medical subject headings: Behavior, Pain

What participants receive

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

Study groups in NCT06912789
Study group	Role	What they receive
Group 1: tell-show-do application		The treatment procedure and the exact steps will be explained to the child verbally, after which all the tools and equipment required for the treatment will be shown to the child, before the pulpotomy is performed.
Group 2: tell-show-do with video modeling application		The treatment procedure and the exact steps will be explained to the child with TSD, a 4 min 33 sec behavioral guidance video will be presented to the child (https://youtu.be/ir1cyjqsWq4?si=pn7jPwzcDfuMHcq).
Group 3: tell-show-do with mobile phone application		The treatment procedure and the exact steps will be explained to the child with tell-show-do and the Roogies application will be presented to the children together. Roogies is a freely available application (https://apps.apple.com/tr/app/roogies/id1542220556?l=tr).

What is being measured

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

The primary outcomes of this study will be assessed through physiological measurements ( Blood Pressure)
Systolic Blood Pressure (SBP) and diastolic blood pressure (DBP) will be recorded at multiple time points during the procedure: before the procedure, after the administration of local anesthesia, after pulpotomy, and at the end of the procedure.
Each patient will rest for 15 minutes before BP measurement. Measurements will be taken from the right wrist with the child in an upright position using an automatic wrist blood pressure device (Wohler, Türkiye). Systolic (SBP) and diastolic blood pressure (DBP) values in cm of mercury (cmHg) will be recorded.
Measured: 3 months
The primary outcomes of this study will be assessed through physiological measurements (Heart rate)
Heart rate (HR) will be measured while the child is in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger. HR values on the digital monitor will be measured as beats per minute.
Measured: 3 months
The primary outcomes of this study will be assessed through physiological measurements (hemoglobin oxygen saturation)
Hemoglobin oxygen saturation (SPO2) will be measured while the child is in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger. SPO2 values on the digital monitor will be measured as a percentage.
Measured: 3 months
The primary outcomes of this study will be assessed through psychometric measurements (The Faces Version of the Modified Child Dental Anxiety Scale)
The Faces Version of the Modified Child Dental Anxiety Scale (MCDAS f) will be used to measure the level of anxiety experienced by the children throughout the procedure.
For this scale, there are five possible responses consisting of smiling or sad faces, appropriate for each answer given by the child. A happy face corresponds to 1 point whereas a very sad face corresponds to 5 points.
After the dental treatment, the children in all three groups will be asked the questions, after which the scores corresponding to the facial expressions will be chosen by the children and will be recorded by the pediatric dentist. The total score will be calculated as a minimum of 8 and a maximum of 40, with high anxiety being associated with an increasing score.
Measured: 3 months
The primary outcomes of this study will be assessed through evaluation of dental pain perception (The Wong-Baker Faces Pain Rating Scale)
The Wong-Baker Faces Pain Rating Scale (WBFPRS) will be utilized to assess the pain intensity as reported by the children during the dental treatment.
Wong-Baker Faces Pain Rating Scale (WBFPRS) includes six facial expressions ranging from a smiling face to a crying face.
These expressions were explained to the children who were asked to choose the face that best reflected the level of pain they felt during treatment. A smiling face was 0 points (no pain) whereas a crying face was 10 points (very severe pain).
After physiological and psychometric measurements are recorded, the pediatric dentist will use the WBFBS score to evaluate the children's pain perception. The scoring will be recorded by the same pediatric dentist.
With high dental anxiety associated with an increasing score.
Measured: 3 months
The primary outcomes of this study will be assessed through evaluation of dental pain perception (Face, Legs, Activity, Cry, Consolability)
The Face, Legs, Activity, Cry, Consolability (FLACC) pain scale will be applied to evaluate the child's pain and distress based on observable behavior during the procedure.
The measurement will be made by evaluating five behavioral categories (i.e., face, legs, activity, crying, and consolability). Each parameter will be scored between 0 and 2, and the total score will range between 0 and 10, where 0 will indicate calm and comfortable, 1-3 will represent mild discomfort, 4-6 will indicate moderate pain, and 7-10 will signify severe discomfort or pain, or both. A score closer to 10 will indicate severe pain, whereas 0 will mean no pain.
Measured: 3 months

Timeline

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

3 Jan 202410 Jan 2025

First posted6 Apr 2025
Study start3 Jan 2024
Primary completion3 Jan 2025
Study completion10 Jan 2025

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 BehaviorStudies 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: Case-control
Time perspective: Cross-sectional
Enrolment: 63 participants (actual)
Target duration: 6 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT06912789
Sponsor's protocol ID: 2023/244
Acronym: Pediatrics
Status last verified: Apr 2025
First submitted: 26 Mar 2025
Last updated: 6 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yazar M, Aydinoglu S, Gunacar DN. Are technological contributions in behavior guidance techniques superior to conventional methods?: Effects on dental anxiety and pain perception. BMC Oral Health. 2025 May 17;25(1):735. doi: 10.1186/s12903-025-06139-3.
PubMed 40382626

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Are Technological Contributions in Behavior Guidance Techniques Superior to Conventional Methods? : Effects on Dental Anxiety and Pain Perception in Pulpotomy Treatment
ClinicalTrials.gov ID: NCT06912789
Acronym / sponsor ID: Pediatrics / 2023/244
Conditions: Behavior, Child, Dental Anxiety, Mobile Applications, Pain
Study type: Observational
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
Study start: 3 Jan 2024 (actual)
Primary completion: 3 Jan 2025 (actual)
Study completion: 10 Jan 2025 (actual)
First posted: 6 Apr 2025 (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 aims to evaluate the effects of three different behavior guidance methods on children's dental anxiety and pain perception.

Detailed description

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Target follow-up: 6 Days
Number of arms: 3

Arm	Type	Receives
Group 1: tell-show-do application	–	–The treatment procedure and the exact steps will be explained to the child verbally, after which all the tools and equipment required for the treatment will be shown to the child, before the pulpotomy is performed.
Group 2: tell-show-do with video modeling application	–	–The treatment procedure and the exact steps will be explained to the child with TSD, a 4 min 33 sec behavioral guidance video will be presented to the child (https://youtu.be/ir1cyjqsWq4?si=pn7jPwzcDfuMHcq).
Group 3: tell-show-do with mobile phone application	–	–The treatment procedure and the exact steps will be explained to the child with tell-show-do and the Roogies application will be presented to the children together. Roogies is a freely available application (https://apps.apple.com/tr/app/roogies/id1542220556?l=tr).

Who may qualify

Ages: 6 to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Pediatric population

Key inclusion criteria (8 listed)

the patients had no previous dental treatment,
were between ages 6 and 8 years, accepted treatment accompanied by parents,
scored 3 (positive) or 4 (definitely positive) on the Frankl behavior scale,
had no systemic disease,
did not need emergency dental treatment, one of the upper molars required pulpotomy followed by a Class II composite restoration,

Key exclusion criteria (4 listed)

Patients who did not meet the inclusion criteria included those who needed other asymptomatic root canal treatment other than pulpotomy indication,
needed restorative treatment due to a history of dental trauma, those who did not want to be included voluntarily,
who cried during the procedure or left the treatment unfinished,
who were determined to be negative (2) or definitely negative (1) according to the Frankl behavior assessment scale.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

The primary outcomes of this study will be assessed through physiological measurements ( Blood Pressure)
Time frame: 3 months
Systolic Blood Pressure (SBP) and diastolic blood pressure (DBP) will be recorded at multiple time points during the procedure: before the procedure, after the administration of local anesthesia, after pulpotomy, and at the end of the procedure. Each patient will rest for 15 minutes before BP measurement. Measurements will be taken from the right wrist with the child in an upright position using an automatic wrist blood pressure device (Wohler, Türkiye). Systolic (SBP) and diastolic blood pressure (DBP) values in cm of mercury (cmHg) will be recorded.
The primary outcomes of this study will be assessed through physiological measurements (Heart rate)
Time frame: 3 months
Heart rate (HR) will be measured while the child is in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger. HR values on the digital monitor will be measured as beats per minute.
The primary outcomes of this study will be assessed through physiological measurements (hemoglobin oxygen saturation)
Time frame: 3 months
Hemoglobin oxygen saturation (SPO2) will be measured while the child is in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger. SPO2 values on the digital monitor will be measured as a percentage.
The primary outcomes of this study will be assessed through psychometric measurements (The Faces Version of the Modified Child Dental Anxiety Scale)
Time frame: 3 months
The Faces Version of the Modified Child Dental Anxiety Scale (MCDAS f) will be used to measure the level of anxiety experienced by the children throughout the procedure. For this scale, there are five possible responses consisting of smiling or sad faces, appropriate for each answer given by the child. A happy face corresponds to 1 point whereas a very sad face corresponds to 5 points. After the dental treatment, the children in all three groups will be asked the questions, after which the scores corresponding to the facial expressions will be chosen by the children and will be recorded by the pediatric dentist. The total score will be calculated as a minimum of 8 and a maximum of 40, with high anxiety being associated with an increasing score.
The primary outcomes of this study will be assessed through evaluation of dental pain perception (The Wong-Baker Faces Pain Rating Scale)
Time frame: 3 months
The Wong-Baker Faces Pain Rating Scale (WBFPRS) will be utilized to assess the pain intensity as reported by the children during the dental treatment. Wong-Baker Faces Pain Rating Scale (WBFPRS) includes six facial expressions ranging from a smiling face to a crying face. These expressions were explained to the children who were asked to choose the face that best reflected the level of pain they felt during treatment. A smiling face was 0 points (no pain) whereas a crying face was 10 points (very severe pain). After physiological and psychometric measurements are recorded, the pediatric dentist will use the WBFBS score to evaluate the children's pain perception. The scoring will be recorded by the same pediatric dentist. With high dental anxiety associated with an increasing score.
The primary outcomes of this study will be assessed through evaluation of dental pain perception (Face, Legs, Activity, Cry, Consolability)
Time frame: 3 months
The Face, Legs, Activity, Cry, Consolability (FLACC) pain scale will be applied to evaluate the child's pain and distress based on observable behavior during the procedure. The measurement will be made by evaluating five behavioral categories (i.e., face, legs, activity, crying, and consolability). Each parameter will be scored between 0 and 2, and the total score will range between 0 and 10, where 0 will indicate calm and comfortable, 1-3 will represent mild discomfort, 4-6 will indicate moderate pain, and 7-10 will signify severe discomfort or pain, or both. A score closer to 10 will indicate severe pain, whereas 0 will mean no pain.

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 Apr 2025.
Derived from this study: PubMed 40382626Yazar M, Aydinoglu S, Gunacar DN. Are technological contributions in behavior guidance techniques superior to conventional methods?: Effects on dental anxiety and pain perception. BMC Oral Health. 2025 May 17;25(1):735. doi: 10.1186/s12903-025-06139-3.
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.

Dilara Nil Günaçar, Assoc. Prof. study chair

Recep Tayyip Erdogan 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?

An observational study of Behavior and Child, run by Recep Tayyip Erdogan University Training and Research Hospital 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 8 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 6 Apr 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?

The primary outcomes of this study will be assessed through physiological measurements ( Blood Pressure) (time frame: 3 months). The study lists 6 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 NCT06912789, 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 6 Apr 2025.