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

This research contributes to a deeper understanding of the etiopathogenesis of periodontal and other oral diseases in children with T1D. By analyzing the composition of the salivary microbiome and detecting pathogenic and opportunistic microorganisms, the study aims to develop targeted preventive strategies. The findings could lead to personalized preventive programs, improving early diagnosis and oral health management in this vulnerable population.This study hypothesizes that children with Type 1 Diabetes (T1D) will exhibit significantly different oral health parameters compared to healthy peers. Specifically: 1. Higher KEP and KEPS index values (Klein-Palmer system) indicating increased caries incidence. 2. Higher Silness and Loe plaque index and Loe and Silness gingival index, suggesting greater plaque accumulation and gingival inflammation. 3. Lower salivary buffering capacity and pH, potentially contributing to an increased risk of oral diseases. 4. A distinct microbial profile, with a greater presence of pathogenic and opportunistic bacteria. 5. A significantly higher Candida albicans count in the saliva. These findings could provide insights into the oral health challenges faced by children with T1D and guide preventive strategies. This study explores how saliva can help assess the risk of dental and gum problems in children with Type 1 Diabetes (T1D). Researchers will analyze saliva samples to identify specific markers that may indicate a higher chance of cavities, gum disease, and oral infections. The goal is to develop early detection and prevention methods to improve oral health care for children with T1D. The study will include 112 children aged 6 to 18. Half of them have Type 1 Diabetes, while the other half are healthy children of the same age and gender for comparison. All participants will be selected from the Clinic for Dentistry of Vojvodina, ensuring they are not currently sick and have not taken antibiotics in the past month. Children with other serious health conditions, fixed braces, or difficulty cooperating will not be included. Researchers will examine different factors that could affect oral health in children with T1D, including saliva acidity (pH), its ability to neutralize acids, the presence of bacteria and fungi, and the condition of teeth and gums. They expect that children with T1D will have: 1. More cavities compared to healthy children. 2. More plaque buildup on teeth and greater gum inflammation. 3. Lower saliva protection against acids, increasing the risk of dental problems. 4. A different mix of bacteria in the mouth, with more potentially harmful microbes. 5. Higher levels of the fungus Candida albicans in saliva. The findings from this study may help better understand oral health challenges in children with T1D and lead to improved prevention and treatment strategies.

NCT Number	NCT06924372
Lead Sponsor	University of Novi Sad
Conditions	Biomarkers, Saliva, Type 1 Diabetes (T1D), Dental Care for Children
Enrollment	112 participants
Start Date	2025-01-31
Primary Completion	2025-07-01 (estimated)
Study Completion	2025-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-04-11