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

Summary

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.

Conditions

• Biomarkers
• Saliva
• Type 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.

Sponsors & Collaborators

• University of Novi Sad

  lead OTHER

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-31

Primary Completion

2025-07-01

Completion

2025-12-01

Countries

• Serbia

Study Locations