Early Childhood CariesLESSENNCT05352841
Leptin, Adiponectin, FRAP and Tac in Patients With Early Childhood Caries
An observational study of Early Childhood Caries, run by University of Novi Sad at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 72 months
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Salivary sample analysis
- How many people
- 40 participants
- Where
- 1 siteSerbia
- Study dates
- 30 Mar 2022to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 72 months
- All sexes
- Child
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.
Who may be able to join
- children younger than 72 months
- pediatrician confirmation of apropriate growth and development/weight pattern
- referral from the specialist in pediatric and preventive dentistry
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
Faculty of Medicine, University of Novi Sad
Novi Sad, Vojvodina, 21000
Bojan Petrovic, Professor, +3816363342639, bojan.petrovic@mf.uns.ac.rs
About this study
Official title: Determination of Salivary Concentrations of Leptin and Adiponectin, Ability to Reduce Ferric Ions and Total Antioxidant Capacity of Saliva in Patients With Early Childhood Caries
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.
Read the detailed description
Early childhood caries (ECC) is the most common chronic non-communicable disease in preschool children, and is defined as the presence of one or more carious (uncavitated or cavited) lesions, the absence of one or more teeth (due to caries) or the presence of fillings. any deciduous tooth in a child 72 months of age or younger. Early childhood caries is a disease that is directly dependent on diet. Early childhood caries research is increasingly focused on establishing a link between general and oral health, as well as a local and systemic response to this disease. Antioxidants present in the human body include compounds that act to reduce oxidative stress and the action of free radicals on the human body. It is thought that saliva, through salivary antioxidants, may be the first line of defense against oxidative stress. Salivary antioxidants are a group of enzymes consisting of salivary peroxidase, salivary uric acid, and several smaller enzymes. The combined activity of these enzymes in reducing oxidative stress is often referred to in the literature as Total Antioxidant Capacity (TAC) of saliva. The connection between early childhood caries, rampant caries and increased total antioxidant capacity of saliva has already been described in the literature. Also, the total antioxidant capacity of saliva has been shown to have a linear relationship with age, while no significant dependence has been shown with sex. TAC and Feric Reduction Power (FRAP) have also been studied in patients with periodontitis. Lower TAC and FRAP values in unstimulated and stimulated saliva were confirmed, however, TAC and FRAP concentrations could not be related to the degree and stage of periodontal disease.
Leptin and adiponectin are considered key biomarkers of metabolic dysregulation and comorbidity in both children and adults. Leptin is a polypeptide hormone of 167 amino acids derived from adipocytes, which has been shown to reduce nutrient intake and increase energy expenditure. Its serum concentration is positively associated with total body fat in adults and children. Leptin is a hormone that regulates food intake and energy distribution. It is a protein secreted primarily by fat cells. The salivary glands produce, store and secrete leptin and its level increases with the flow of saliva. A link between leptin levels and tooth loosening during orthodontic treatment has also been found. On the other hand, patients with advanced periodontal disease had lower levels of this hormone. Its role in other diseases of the oral cavity has not been fully investigated. Adiponectin is an adipocyte-derived hormone that regulates glucose and lipid metabolism, improves fatty acid oxidation and insulin sensitivity, and inhibits glucose production in the liver. In addition, adiponectin has strong anti-inflammatory properties. In addition to its previously mentioned local effects, adiponectin in breast milk is involved in the regulation of energy balance regulation and may play a role in the regulation of growth and development in the neonatal period and childhood. Adiponectin is also locally produced in the oral cavity, salivary glands and its level is significantly correlated with plasma levels and as such salivary adiponectin has been used as an alternative to blood tests to measure adiponectin levels.
- Conditions
- Early Childhood Caries
- Being tested
- Salivary sample analysis
- Keywords
- Total antioxidant capacity, FRAP, Leptin, Adiponectin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary sample analysisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Caries free children | Children old 72 months or younger with no caries lesion Receives: 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. Receives: Diagnostic Test: Salivary sample analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Salivary levels of FRAP in caries free children and children with s ECC
Result expressed as mM Fe equivalents
Measured: 1 month
Salivary levels of leptin in caries free children and children with s ECC
Result expressed in pg / ml
Measured: 1 month
Salivary levels of adiponectin in caries free children and children with s ECC
Result expressed in μg / ml
Measured: 1 month
Secondary outcomes (1)
Interrelationship between FRAP, TAC, leptin and adiponectin in caries free children and children with s ECC
Statistical analysis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start30 Mar 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bojan Petrovic, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352841
- Sponsor's protocol ID
- 02-2021
- Acronym
- LESSEN
- Status last verified
- Apr 2022
- First submitted
- 24 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Salivary Concentrations of Leptin and Adiponectin, Ability to Reduce Ferric Ions and Total Antioxidant Capacity of Saliva in Patients With Early Childhood Caries
- ClinicalTrials.gov ID
- NCT05352841
- Acronym / sponsor ID
- LESSEN / 02-2021
- Conditions
- Early Childhood Caries
- Keywords
- Total antioxidant capacity, FRAP, Leptin, Adiponectin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Early childhood caries (ECC) is the most common chronic non-communicable disease in preschool children, and is defined as the presence of one or more carious (uncavitated or cavited) lesions, the absence of one or more teeth (due to caries) or the presence of fillings. any deciduous tooth in a child 72 months of age or younger. Early childhood caries is a disease that is directly dependent on diet. Early childhood caries research is increasingly focused on establishing a link between general and oral health, as well as a local and systemic response to this disease. Antioxidants present in the human body include compounds that act to reduce oxidative stress and the action of free radicals on the human body. It is thought that saliva, through salivary antioxidants, may be the first line of defense against oxidative stress. Salivary antioxidants are a group of enzymes consisting of salivary peroxidase, salivary uric acid, and several smaller enzymes. The combined activity of these enzymes in reducing oxidative stress is often referred to in the literature as Total Antioxidant Capacity (TAC) of saliva. The connection between early childhood caries, rampant caries and increased total antioxidant capacity of saliva has already been described in the literature. Also, the total antioxidant capacity of saliva has been shown to have a linear relationship with age, while no significant dependence has been shown with sex. TAC and Feric Reduction Power (FRAP) have also been studied in patients with periodontitis. Lower TAC and FRAP values in unstimulated and stimulated saliva were confirmed, however, TAC and FRAP concentrations could not be related to the degree and stage of periodontal disease.
Leptin and adiponectin are considered key biomarkers of metabolic dysregulation and comorbidity in both children and adults. Leptin is a polypeptide hormone of 167 amino acids derived from adipocytes, which has been shown to reduce nutrient intake and increase energy expenditure. Its serum concentration is positively associated with total body fat in adults and children. Leptin is a hormone that regulates food intake and energy distribution. It is a protein secreted primarily by fat cells. The salivary glands produce, store and secrete leptin and its level increases with the flow of saliva. A link between leptin levels and tooth loosening during orthodontic treatment has also been found. On the other hand, patients with advanced periodontal disease had lower levels of this hormone. Its role in other diseases of the oral cavity has not been fully investigated. Adiponectin is an adipocyte-derived hormone that regulates glucose and lipid metabolism, improves fatty acid oxidation and insulin sensitivity, and inhibits glucose production in the liver. In addition, adiponectin has strong anti-inflammatory properties. In addition to its previously mentioned local effects, adiponectin in breast milk is involved in the regulation of energy balance regulation and may play a role in the regulation of growth and development in the neonatal period and childhood. Adiponectin is also locally produced in the oral cavity, salivary glands and its level is significantly correlated with plasma levels and as such salivary adiponectin has been used as an alternative to blood tests to measure adiponectin levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caries free children | – | Diagnostic Test: Salivary sample analysisChildren old 72 months or younger with no caries lesion |
| Children with severe form of early childhood caries | – | Diagnostic Test: Salivary sample analysisChildren 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. |
Who may qualify
- Ages
- 6 to 72 months
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- children younger than 72 months
- pediatrician confirmation of apropriate growth and development/weight pattern
- referral from the specialist in pediatric and preventive dentistry
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary sample analysisThe 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. | Diagnostic test | Caries free children, Children with severe form of early childhood caries |
Primary outcome
Salivary levels of TAC in caries free children and children with s ECC
Time frame: 1 month
ABTS: Result expressed asTotal Antioxidative Capacity (TAC), unit μg/ml Trolox equivalents
Salivary levels of FRAP in caries free children and children with s ECC
Time frame: 1 month
Result expressed as mM Fe equivalents
Salivary levels of leptin in caries free children and children with s ECC
Time frame: 1 month
Result expressed in pg / ml
Salivary levels of adiponectin in caries free children and children with s ECC
Time frame: 1 month
Result expressed in μg / ml
1 secondary outcome
Interrelationship between FRAP, TAC, leptin and adiponectin in caries free children and children with s ECC
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty of Medicine, University of Novi Sad
Novi Sad, Serbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Childhood Caries, run by University of Novi Sad at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary levels of TAC in caries free children and children with s ECC (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.