- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07625982
A Comparison of Teledentistry vs Clinical Examination for Treatment Needs Assesment
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.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Istanbul, Tyrkiet (Türkiye)
- Bezmialem Vakif University Faculty of Dentistry Department of PEdiatric Dentistry
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Minimal participant number to compare teledentistry and clinical exam
Tidsramme: 5 months
|
5 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2021/ 105
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .