Preschool ChildrenNCT07625982
A Comparison of Teledentistry vs Clinical Examination for Treatment Needs Assesment
An observational study of Preschool Children and Dental Caries in Primary Teeth, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Dental caries is one of the most common chronic diseases in children and may require complex dental treatment, especially in preschool-aged children. Because young children may have limited ability to cooperate during dental procedures, determining the urgency of treatment and the need for behavior guidance is an… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Preschool Children, Dental Caries in Primary Teeth
- What is being tested?
- Tele- dentistry intraoral exam
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 10 Feb 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children attending an initial dental examination appointment at the Department of Pediatric Dentistry, Faculty of Dentistry, Bezmialem Vakıf University, between July 2021 and November 2021, and who met the inclusion and exclusion criteria, were enrolled in the study after obtaining informed consent from parents/legal guardians.
Who may be able to join
- Children without any systemic mental or physical disorders
- Children not using medication for psychiatric reasons
- Children without diagnosed learning or comprehension difficulties (e.g., attention deficit and hyperactivity disorder)
- Children without an indication for general anesthesia due to any other medical procedure
- Children without transportation barriers to access the healthcare facility
Who cannot join
- Children whose parents/legal guardians refuse to sign the informed consent form
- Children from families lacking the necessary equipment for video-based teleconferencing
- Children whose parents/legal guardians do not consent to participation in video consultations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University Faculty of Dentistry Department of PEdiatric Dentistry
Istanbul
About this study
Official title: Comparison of Teledentistry and Clinical Examination for Treatment Needs and Behavior Guidance in Preschool Children: A Cross-Sectional Study
Dental caries is one of the most common chronic diseases in children and may require complex dental treatment, especially in preschool-aged children. Because young children may have limited ability to cooperate during dental procedures, determining the urgency of treatment and the need for behavior guidance is an important part of treatment planning.
Teledentistry may provide an alternative method for the initial assessment of children who have difficulty accessing dental care. Through video calls and/or clinical photographs, dentists may be able to obtain information about the child's oral health status, pain complaints, treatment needs, and expected cooperation before an in-person visit.
Read more
The purpose of this study is to evaluate the agreement between teledental examination and conventional clinical examination in preschool children. The study will compare the treatment needs identified during teledental examination with those identified during clinical examination. Treatment needs will be classified as urgent or elective. The study will also compare the recommended type of behavior guidance, categorized as non-pharmacological or pharmacological, between the two examination methods.
Healthy children aged 4 to 6 years who attend their first dental examination appointment and have no special care needs will be included after parental consent is obtained. Each child will undergo both a clinical examination and a teledental examination. During both examinations, data on pain complaints, dental caries experience, treatment needs, and predicted cooperation during dental treatment will be recorded using standardized forms.
The study hypothesis is that teledental examination will show acceptable agreement with clinical examination in identifying urgent and elective dental treatment needs and in determining the recommended type of behavior guidance in preschool children.
Read the detailed description
This study was designed to evaluate the agreement between teledental examination and conventional clinical examination in determining dental treatment needs and the recommended type of behavior guidance in preschool children.
Dental caries is common in preschool-aged children and may require urgent or elective dental treatment. In this age group, treatment planning is affected not only by the presence and severity of dental disease but also by the child's developmental stage, previous dental experience, anxiety, and ability to cooperate. Teledentistry may provide a useful preliminary assessment method for children who have difficulty accessing dental care, particularly by helping clinicians identify urgent treatment needs and anticipate the need for behavior guidance before an in-person appointment.
Healthy children aged 4 to 6 years who attended their first dental examination appointment at the pediatric dentistry clinic were included after parental consent was obtained. Children with special care needs and children with an indication for general anesthesia due to another medical procedure were not included. Each participant underwent both a conventional clinical examination and a teledental examination.
The clinical examination was performed in the dental clinic with the child seated in the dental chair, under dental unit light, using a dental mirror and probe, and in the presence of a parent. The teledental examination was performed via a scheduled video call with the child and parent. During the teledental examination, information was obtained through visual assessment, parent-assisted intraoral observation when possible, and parent/child report of symptoms.
For both examination methods, data were recorded using standardized forms. The recorded variables included pain complaints, including spontaneous pain, provoked pain, and pain associated with food impaction. Each of these pain-related variables was recorded as present or absent. Dental caries experience was recorded using the dmf index for primary dentition. Treatment needs were categorized as urgent or elective according to the findings of each examination.
The recommended type of behavior guidance was also recorded for both examination methods. In determining the suggested behavior guidance approach, the child's dental history, medical history, parental report, expected cooperation, and clinical findings were considered. Behavior guidance recommendations were categorized as non-pharmacological or pharmacological. The predicted child behavior during dental treatment was recorded using the Frankl Behavior Rating Scale according to parental report.
Before the main study, inter-examiner reliability was evaluated in a group of children outside the study sample. Data obtained from the clinical and teledental examinations were then compared to assess agreement between the two examination methods.
Statistical analysis was performed using IBM SPSS Statistics. Descriptive statistics were presented as mean, standard deviation, and frequency, as appropriate. The McNemar test was used to compare paired categorical variables between clinical examination and teledental examination. Cohen's kappa coefficient was calculated to determine the level of agreement between the two examination methods. Statistical significance was set at p < 0.05.
The main objective of the study was to determine whether teledental examination could provide acceptable agreement with conventional clinical examination in identifying urgent and elective treatment needs and in determining the recommended type of behavior guidance in preschool children.
- Conditions
- Preschool Children, Dental Caries in Primary Teeth
- Being tested
- Tele- dentistry intraoral exam
- Keywords
- tele-medicine, tele-dentistry, pediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele- dentistry intraoral examDiagnostic test
Complaints of pain: spontaneous pain, provoked pain, food impaction (yes/no) were recorded, the dmf index was recorded in both examinations, treatment needs were categorized as elective or urgent using teledentistry and clinical exam.
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal participant number to compare teledentistry and clinical exam
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jul 2021
- Primary completion30 Nov 2021
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preschool ChildrenStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Sarp Kaya, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625982
- Sponsor's protocol ID
- 2021/ 105
- Status last verified
- Mar 2026
- First submitted
- 23 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Teledentistry and Clinical Examination for Treatment Needs and Behavior Guidance in Preschool Children: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07625982
- Acronym / sponsor ID
- 2021/ 105
- Conditions
- Preschool Children, Dental Caries in Primary Teeth
- Keywords
- tele-medicine, tele-dentistry, pediatric dentistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 4 Jun 2026 (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.
Dental caries is one of the most common chronic diseases in children and may require complex dental treatment, especially in preschool-aged children. Because young children may have limited ability to cooperate during dental procedures, determining the urgency of treatment and the need for behavior guidance is an important part of treatment planning.
Teledentistry may provide an alternative method for the initial assessment of children who have difficulty accessing dental care. Through video calls and/or clinical photographs, dentists may be able to obtain information about the child's oral health status, pain complaints, treatment needs, and expected cooperation before an in-person visit.
The purpose of this study is to evaluate the agreement between teledental examination and conventional clinical examination in preschool children. The study will compare the treatment needs identified during teledental examination with those identified during clinical examination. Treatment needs will be classified as urgent or elective. The study will also compare the recommended type of behavior guidance, categorized as non-pharmacological or pharmacological, between the two examination methods.
Healthy children aged 4 to 6 years who attend their first dental examination appointment and have no special care needs will be included after parental consent is obtained. Each child will undergo both a clinical examination and a teledental examination. During both examinations, data on pain complaints, dental caries experience, treatment needs, and predicted cooperation during dental treatment will be recorded using standardized forms.
The study hypothesis is that teledental examination will show acceptable agreement with clinical examination in identifying urgent and elective dental treatment needs and in determining the recommended type of behavior guidance in preschool children.
Detailed description
This study was designed to evaluate the agreement between teledental examination and conventional clinical examination in determining dental treatment needs and the recommended type of behavior guidance in preschool children.
Dental caries is common in preschool-aged children and may require urgent or elective dental treatment. In this age group, treatment planning is affected not only by the presence and severity of dental disease but also by the child's developmental stage, previous dental experience, anxiety, and ability to cooperate. Teledentistry may provide a useful preliminary assessment method for children who have difficulty accessing dental care, particularly by helping clinicians identify urgent treatment needs and anticipate the need for behavior guidance before an in-person appointment.
Healthy children aged 4 to 6 years who attended their first dental examination appointment at the pediatric dentistry clinic were included after parental consent was obtained. Children with special care needs and children with an indication for general anesthesia due to another medical procedure were not included. Each participant underwent both a conventional clinical examination and a teledental examination.
The clinical examination was performed in the dental clinic with the child seated in the dental chair, under dental unit light, using a dental mirror and probe, and in the presence of a parent. The teledental examination was performed via a scheduled video call with the child and parent. During the teledental examination, information was obtained through visual assessment, parent-assisted intraoral observation when possible, and parent/child report of symptoms.
For both examination methods, data were recorded using standardized forms. The recorded variables included pain complaints, including spontaneous pain, provoked pain, and pain associated with food impaction. Each of these pain-related variables was recorded as present or absent. Dental caries experience was recorded using the dmf index for primary dentition. Treatment needs were categorized as urgent or elective according to the findings of each examination.
The recommended type of behavior guidance was also recorded for both examination methods. In determining the suggested behavior guidance approach, the child's dental history, medical history, parental report, expected cooperation, and clinical findings were considered. Behavior guidance recommendations were categorized as non-pharmacological or pharmacological. The predicted child behavior during dental treatment was recorded using the Frankl Behavior Rating Scale according to parental report.
Before the main study, inter-examiner reliability was evaluated in a group of children outside the study sample. Data obtained from the clinical and teledental examinations were then compared to assess agreement between the two examination methods.
Statistical analysis was performed using IBM SPSS Statistics. Descriptive statistics were presented as mean, standard deviation, and frequency, as appropriate. The McNemar test was used to compare paired categorical variables between clinical examination and teledental examination. Cohen's kappa coefficient was calculated to determine the level of agreement between the two examination methods. Statistical significance was set at p < 0.05.
The main objective of the study was to determine whether teledental examination could provide acceptable agreement with conventional clinical examination in identifying urgent and elective treatment needs and in determining the recommended type of behavior guidance in preschool children.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children attending an initial dental examination appointment at the Department of Pediatric Dentistry, Faculty of Dentistry, Bezmialem Vakıf University, between July 2021 and November 2021, and who met the inclusion and exclusion criteria, were enrolled in the study after obtaining informed consent from parents/legal guardians.
Key inclusion criteria (5 listed)
- Children without any systemic mental or physical disorders
- Children not using medication for psychiatric reasons
- Children without diagnosed learning or comprehension difficulties (e.g., attention deficit and hyperactivity disorder)
- Children without an indication for general anesthesia due to any other medical procedure
- Children without transportation barriers to access the healthcare facility
Key exclusion criteria (3 listed)
- Children whose parents/legal guardians refuse to sign the informed consent form
- Children from families lacking the necessary equipment for video-based teleconferencing
- Children whose parents/legal guardians do not consent to participation in video consultations
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 |
|---|---|---|
| Tele- dentistry intraoral examComplaints of pain: spontaneous pain, provoked pain, food impaction (yes/no) were recorded, the dmf index was recorded in both examinations, treatment needs were categorized as elective or urgent using teledentistry and clinical exam. | Diagnostic test | – |
Primary outcome
Minimal participant number to compare teledentistry and clinical exam
Time frame: 5 months
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 4 Jun 2026.
- 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.
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 Preschool Children and Dental Caries in Primary Teeth, run by Bezmialem Vakif 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 5 inclusion and 3 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 4 Jun 2026. 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?
Minimal participant number to compare teledentistry and clinical exam (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.