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

NCT06924372 | Active Not Recruiting

• 1 other identifier: Number:01-17/13-2023
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 1.Higher KEP and KEPS index values (Klein-Palmer system) indicating increased caries incidence.
2. 2.Higher Silness and Loe plaque index and Loe and Silness gingival index, suggesting greater plaque accumulation and gingival inflammation.
3. 3.Lower salivary buffering capacity and pH, potentially contributing to an increased risk of oral diseases.
4. 4.A distinct microbial profile, with a greater presence of pathogenic and opportunistic bacteria.
5. 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.
6. 6.More cavities compared to healthy children.
7. 7.More plaque buildup on teeth and greater gum inflammation.
8. 8.Lower saliva protection against acids, increasing the risk of dental problems.
9. 9.A different mix of bacteria in the mouth, with more potentially harmful microbes.
10. 10.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

Keywords

salivary biomarkers; type 1 diabetes T1D; children; oral disease

Outcome Measures

Primary Outcomes (2)

• Prevalence of dental caries and periodontal disease

  The primary outcome of the study is the prevalence of dental caries and periodontal diseases in children with type 1 diabetes, compared to non-diabetic children. Caries prevalence will be defined using KEP and KEPS indexes according to the Klein-Palmer system and assessment of the amount of dental plaque using the Silness and Loe plaque index and assessment of gingival condition using the gingival index Loe and Silness .

  From 31 January 2025 to January 2026

• Microbiological analysis

  The primary outcome of this clinical research is to evaluate the feasibility and effectiveness of collecting unstimulated saliva samples for microbiological procedures and analysis. Specifically, the study aims to determine whether unstimulated saliva can serve as a reliable diagnostic medium for the identification and characterization of isolated microorganisms present in the oral cavity. The identification of these microorganisms will be carried out using standard microbiological techniques to assess the microbial composition and potential pathogenic species. Outcomes will be measured based on data provided after experimental part.

  From 31 January 2025 to January 2026

Secondary Outcomes (2)

• Saliva chek buffer

  From 31 January 2025 to January 2026.

• Saliva ph measurement

  From 31 January 2025 to January 2026

Other Outcomes (1)

• Questionnaire

  From 31 January 2025 to January 2026

Study Arms (2)

Experimental group

Age of subjects from 6 to 18 years, both sexes, with mixed or permanent dentition present. An experimental group of at least 56 subjects will be children diagnosed with DM type 1 (at least one year), who are treated at the Novi Sad Health Center, Children's Health Care Service, and will be referred to the Department of Pediatric and Preventive Dentistry, Clinic for Dentistry of Vojvodina. The experimental group will be divided into two subgroups: at least 28 subjects with well-regulated type 1 DM and at least 28 subjects with poorly regulated type 1 DM.

Other: Taking saliva samples of unstimulated saliva will be collected in sterile containers, salivets.; Other: Dental status; Other: Periodontal status

Control group

The control group includes at least 56 subjects, healthy children, who match the tested group in gender and age, patients of the Clinic of Dentistry of Vojvodina, with the absence of acute diseases. Age of subjects from 6 to 18 years, both sexes, with mixed or permanent dentition present.

Other: Taking saliva samples of unstimulated saliva will be collected in sterile containers, salivets.; Other: Dental status; Other: Periodontal status

Interventions

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

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.

Control group; Experimental group

Dental status OTHER

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.

Control group; Experimental group

Periodontal status OTHER

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.

Control group; Experimental group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

An experimental group will be children diagnosed with DM type 1 (at least one year), who are treated at the Novi Sad Health Center, Children's Health Care Service, and will be referred to the Department of Pediatric and Preventive Dentistry, Clinic for Dentistry of Vojvodina. The control group includes healthy children, who match the tested group in gender and age, patients of the Clinic of Dentistry of Vojvodina

You may qualify if:

• Age of subjects from 6 to 18 years, both sexes, with mixed or permanent dentition present.
• An experimental group of at least 56 subjects will be children diagnosed with DM type 1 (at least one year)
• The control group includes at least 56 subjects, healthy children, who match the tested group in gender and age, with the absence of acute diseases.

You may not qualify if:

• Uncooperative patient
• Associated diseases
• Unsigned informative consent from the data subject/parent/guardian
• Antibiotic use in the last few months
• Subjects with orthodontic appliances

Sponsors & Collaborators

• University of Novi Sad: lead

Study Sites (1)

Medical Faculty, University of Novi Sad

Novi Sad, 21000, Serbia

Location

Related Publications (16)

• Ziegler R, Neu A. Diabetes in Childhood and Adolescence. Dtsch Arztebl Int. 2018 Mar 2;115(9):146-156. doi: 10.3238/arztebl.2018.0146.

  PMID: 29563012 BACKGROUND

• Petrovic B, Stilinovic N, Tomas A, Kojic S, Stojanovic GM. Determination of salivary concentrations of leptin and adiponectin, ability to reduce ferric ions and total antioxidant capacity of saliva in patients with severe early childhood caries. Front Pediatr. 2022 Aug 31;10:969372. doi: 10.3389/fped.2022.969372. eCollection 2022.

  PMID: 36120658 BACKGROUND

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  BACKGROUND

• Chi LM, Hsiao YC, Chien KY, Chen SF, Chuang YN, Lin SY, Wang WS, Chang IY, Yang C, Chu LJ, Chiang WF, Chien CY, Chang YS, Chang KP, Yu JS. Assessment of candidate biomarkers in paired saliva and plasma samples from oral cancer patients by targeted mass spectrometry. J Proteomics. 2020 Jan 16;211:103571. doi: 10.1016/j.jprot.2019.103571. Epub 2019 Nov 2.

  PMID: 31689561 BACKGROUND

• Kallianta M, Pappa E, Vastardis H, Rahiotis C. Applications of Mass Spectrometry in Dentistry. Biomedicines. 2023 Jan 19;11(2):286. doi: 10.3390/biomedicines11020286.

  PMID: 36830822 BACKGROUND

• Ahmad P, Hussain A, Siqueira WL. Mass spectrometry-based proteomic approaches for salivary protein biomarkers discovery and dental caries diagnosis: A critical review. Mass Spectrom Rev. 2024 Jul-Aug;43(4):826-856. doi: 10.1002/mas.21822. Epub 2022 Nov 29.

  PMID: 36444686 BACKGROUND

• 12. Classification and Diagnosis of Diabetes: Standards of Care in Diabetes-2023.Diabetes Care 2023; 46 (Suppl. 1): S19-S40.

  BACKGROUND

• Rapone B, Corsalini M, Converti I, Loverro MT, Gnoni A, Trerotoli P, Ferrara E. Does Periodontal Inflammation Affect Type 1 Diabetes in Childhood and Adolescence? A Meta-Analysis. Front Endocrinol (Lausanne). 2020 May 5;11:278. doi: 10.3389/fendo.2020.00278. eCollection 2020.

  PMID: 32431669 BACKGROUND

• Mohamed HG, Idris SB, Mustafa M, Ahmed MF, Astrom AN, Mustafa K, Ibrahim SO. Influence of Type 2 Diabetes on Prevalence of Key Periodontal Pathogens, Salivary Matrix Metalloproteinases, and Bone Remodeling Markers in Sudanese Adults with and without Chronic Periodontitis. Int J Dent. 2016;2016:6296854. doi: 10.1155/2016/6296854. Epub 2016 Feb 17.

  PMID: 26989414 BACKGROUND

• Novotna M, Podzimek S, Broukal Z, Lencova E, Duskova J. Periodontal Diseases and Dental Caries in Children with Type 1 Diabetes Mellitus. Mediators Inflamm. 2015;2015:379626. doi: 10.1155/2015/379626. Epub 2015 Aug 4.

  PMID: 26347009 BACKGROUND

• Animireddy D, Reddy Bekkem VT, Vallala P, Kotha SB, Ankireddy S, Mohammad N. Evaluation of pH, buffering capacity, viscosity and flow rate levels of saliva in caries-free, minimal caries and nursing caries children: An in vivo study. Contemp Clin Dent. 2014 Jul;5(3):324-8. doi: 10.4103/0976-237X.137931.

  PMID: 25191067 BACKGROUND

• Dabelea D. The accelerating epidemic of childhood diabetes. Lancet. 2009 Jun 13;373(9680):1999-2000. doi: 10.1016/S0140-6736(09)60874-6. Epub 2009 May 27. No abstract available.

  PMID: 19481250 BACKGROUND

• Ferizi L, Dragidella F, Spahiu L, Begzati A, Kotori V. The Influence of Type 1 Diabetes Mellitus on Dental Caries and Salivary Composition. Int J Dent. 2018 Oct 2;2018:5780916. doi: 10.1155/2018/5780916. eCollection 2018.

  PMID: 30369949 BACKGROUND

• Nazir MA, AlGhamdi L, AlKadi M, AlBeajan N, AlRashoudi L, AlHussan M. The burden of Diabetes, Its Oral Complications and Their Prevention and Management. Open Access Maced J Med Sci. 2018 Aug 15;6(8):1545-1553. doi: 10.3889/oamjms.2018.294. eCollection 2018 Aug 20.

  PMID: 30159091 BACKGROUND

• Ferizi L, Bimbashi V, Kelmendi J. Association between metabolic control and oral health in children with type 1 diabetes mellitus. BMC Oral Health. 2022 Nov 16;22(1):502. doi: 10.1186/s12903-022-02555-x.

  PMID: 36384715 BACKGROUND

• Assiri SA, El Meligy OAES, Alzain IO, Bamashmous NO. Assessment of dental caries and salivary characteristics among type 1 diabetic Saudi children. J Dent Sci. 2022 Oct;17(4):1634-1639. doi: 10.1016/j.jds.2022.03.010. Epub 2022 Apr 6.

  PMID: 36299323 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Mouth Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor at University of Novi Sad, Medical faculty

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 11, 2025
• Study Start: January 31, 2025
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

SE (1)