Application of Salivary Biomarkers in Risk Assessment for Oral Diseases in Children With Type 1 Diabetes

Active, not recruitingOBSERVATIONAL
Enrollment

112

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

July 1, 2025

Study Completion Date

December 1, 2025

Conditions
BiomarkersSalivaType 1 Diabetes (T1D)Dental Care for Children
Interventions
OTHER

Taking saliva samples of unstimulated saliva will be collected in sterile containers, salivets.

Subjects will sit in a filiological position in a dental chair. Samples of unstimulated saliva will be collected in sterile containers, salivets. A prerequisite for taking saliva samples will be that subjects do not take water and food until two hours before the examination, according to the manufacturer's instructions. SARSTED Salivette will be used. In a sterile manner, the swab will be removed from the salivette with sterile tweezers and applied to the patient's mouth on the buccal mucosa. The tampon will be held for a minimum of 2 minutes in the patient's mouth (with buccal mucosa). After the elapsed time, the tampon will be removed from the mouth, using sterile tweezers and sterile gloves and will be inserted into the saliva and closed. After sampling, the salivates will be transported to the Department of Microbiological Diagnostics of the Institute for Pulmonary Diseases of Vojvodina. Transport should be done in the shortest possible time.

OTHER

Dental status

Dental status in both groups of subjects will be assessed by clinical visual examination by determining the prevalence of caries of deciduous and permanent teeth using the KEP and KEPS indexes. The clinical examination will be carried out in a dental chair using artificial light-reflectors, using a dental mirror and a dental probe on all surfaces of the tooth, which are dried with air from the puster. On the basis of a dental examination, the prevalence of caries of deciduous and permanent teeth will be determined.

OTHER

Periodontal status

The assessment of the presence of dental plaque will be determined visually using the Silness and Loe plaque index, while the condition of the gingiva will be determined using the gingival index Loe and Silness . Before the examination, the subject will be advised to rinse his mouth with water to remove food residues and dental plaque. Performed in the dental chair using artificial light-reflectors, by gently pulling the dental probe over the vestibular, oral, mesial and distal surfaces of all crowns of the present teeth. Four values will be entered for each tooth. The result will be obtained by adding up all the values.

Trial Locations (1)

21000

Medical Faculty, University of Novi Sad, Novi Sad

All Listed Sponsors
lead

University of Novi Sad

OTHER

NCT06924372 - Application of Salivary Biomarkers in Risk Assessment for Oral Diseases in Children With Type 1 Diabetes | Biotech Hunter | Biotech Hunter