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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).

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

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
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

Other trials in Turkey (Türkiye)

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.

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.

  1. 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.

  1. First posted4 Jun 2026
  2. Study start1 Jul 2021
  3. Primary completion30 Nov 2021
  4. Study completion10 Feb 2022

Resources

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)
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

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.

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