Leptin, Adiponectin, FRAP and Tac in Patients With Early Childhood Caries

NCT05352841 | Unknown DMC

• 1 other identifier: 02-2021
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Caries is characterized by the same etiological factors that lead to other chronic non-communicable diseases that are associated with increased dietary sugar intake, such as cardiovascular disease, diabetes and obesity. Early childhood caries is an unacceptable burden for children, families and society. In order to enable the prevention of early childhood caries, it is necessary to actively act on the part of different participants who can influence different aspects of the etiology of caries. Examining the non-specific defense mechanisms of the organism would help shed light on the connection between early childhood caries and other chronic non-communicable diseases, with which they share the same etiological factors. It is also considered that a child has S-ECC if he is 3 to 5 years old, has more than four, five and six tooth surfaces affected in the primary front teeth at 3, 4 and 5 years, respectively. S-ECC replaces the previous term known as "caries of care bottles". By definition, caries in children under 3 years of age involving one or more smooth surfaces and in children under 6 years of age affecting one or more smooth surfaces in the front teeth or total dmfs score ‡ 6 would be classified as S-ECC. These proposed terms appear to be gaining international acceptance in the current dental literature.

Conditions

Early Childhood Caries

Keywords

Total antioxidant capacity; FRAP; Leptin; Adiponectin

Outcome Measures

Primary Outcomes (4)

• Salivary levels of TAC in caries free children and children with s ECC

  ABTS: Result expressed asTotal Antioxidative Capacity (TAC), unit μg/ml Trolox equivalents

  1 month

• Salivary levels of FRAP in caries free children and children with s ECC

  Result expressed as mM Fe equivalents

  1 month

• Salivary levels of leptin in caries free children and children with s ECC

  Result expressed in pg / ml

  1 month

• Salivary levels of adiponectin in caries free children and children with s ECC

  Result expressed in μg / ml

  1 month

Secondary Outcomes (1)

• Interrelationship between FRAP, TAC, leptin and adiponectin in caries free children and children with s ECC

  1 month

Study Arms (2)

Caries free children

Children old 72 months or younger with no caries lesion

Diagnostic Test: Salivary sample analysis

Children with severe form of early childhood caries

Children with severy form of early childhood caries, S-ECC are those having 3 to 5 years , and have more than four, five and six tooth surfaces affected in the primary front teeth at 3, 4 and 5 years, respectively. Caries in children under 3 years of age involving one or more smooth surfaces and in children under 6 years of age affecting one or more smooth surfaces in the front teeth or total dmfs score equal or higher than 6 would be also classified as S-ECC.

Diagnostic Test: Salivary sample analysis

Interventions

Salivary sample analysis DIAGNOSTIC_TEST

The status of caries will be recorded based on the WHO recommendation, 1997. The children will then be divided into two groups depending on whether they are diagnosed caries (group I) or without carious lesions (group II).After the examination, unstimulated saliva will be collected for analysis (subject to all conditions in proper sampling and without contamination) in a sterile disposable laboratory container with a wide opening and lid. Patients will be asked to tilt their head slightly and not swallow or move their tongue or lips during the collection period. Instructions will be given to accumulate saliva in the mouth for a maximum of 2 minutes and he or she will be asked to spit the accumulated saliva into the receiving court. About 1 ml of unstimulated saliva will be collected.

Caries free children; Children with severe form of early childhood caries

Eligibility Criteria

• Age: 6 Months - 72 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

40 patients younger than 72 months. All patients will be presented in writing with the opportunity to participate in a clinical trial and will be asked for written consent. If the parents give written consent, and the child gives oral consent to participate in the study, the usual dental examination will be conducted. For the purposes of the research, no additional questionnaire will be used, but the medical and dental anamnesis will be taken from patients and parents in the usual way. For the purposes of the research, demographic data, dietary habits, medical history, fluoride therapy and the use of drugs and / or vitamin supplements will be detected in particular from the general medical documentation. Also, data will be taken on whether the children have been examined by a pediatrician in the last 6 months and whether a normal pattern of growth, nutrition and general health has been determined.

You may qualify if:

• children younger than 72 months
• pediatrician confirmation of apropriate growth and development/weight pattern
• referral from the specialist in pediatric and preventive dentistry

You may not qualify if:

• children older than 72 months
• presence of chronic medical, intellectual disability
• acute local or symptomic condition
• report aboout deviation from apropriate growth and development/ weight pattern

Sponsors & Collaborators

• University of Novi Sad: lead

Study Sites (1)

Faculty of Medicine, University of Novi Sad

Novi Sad, Vojvodina, 21000, Serbia

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Bojan Petrovic

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: April 29, 2022
• Study Start: March 30, 2022
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)