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HealthyNCT05495373

Can Saliva be the New Bio-fluid to Monitor Children's Oral Health?

An observational study of Healthy, run by Hadassah Medical Organization at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Salivary diagnosis is an emerging field; the potentially valuable biofluid contains many molecules of the systemic circulation. Still, its profile in health has been scarcely investigated. Read more about this study

Who is it for?
Ages 4 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
100 participants
Where
1 siteIsrael
Study dates
1 Jan 2020to 1 Feb 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 4 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: healthy children aged 4-12 visiting for routine dental treatment at hadassah medical center

Inclusion Criteria: healthy cases, no drug consumption or any chronic diseases. -

Exclusion Criteria: antibiotics in last 6 months, during any medical treatment other than dental care.

-

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Hadassah Medical Organization, Jerusalem, Israel

    Jerusalem

Other trials in Israel

About this study

Background: Salivary diagnosis is an emerging field; the potentially valuable biofluid contains many molecules of the systemic circulation. Still, its profile in health has been scarcely investigated.

Aim: This study aimed to characterize the inflammatory profile of healthy children's saliva, and to associate the parameters with clinical diagnoses of caries and gingival inflammation.

Study design: Unstimulated saliva was collected from 100 children who underwent clinical dental examinations. The saliva samples were analysed for total protein, specific cytokines (IL-10, IL-8, IL-6 and TNF- α) and bacteria using Bradford assay, ELISA and quantitative real-time polymerase chain reaction, respectively. Salivary values were analysed according to age, plaque index (PI) and gingival index (GI).

Read the detailed description

Salivary diagnosis is an emerging field that has progressed through several important developments, including salivary proteome and the development of compact point-of-care devices for rapid analysis. Indeed, an increasing number of salivary markers have been identified; and some have been associated with cancer, cardiovascular diseases, autoimmune diseases, viral and bacterial diseases, and human immunodeficiency. Saliva is frequently studied due to the easy, non-invasive, and rapidly obtained collection, without the need for specialized equipment. Moreover, the prodigious fluid source of saliva provides many, if not most, of the molecules found in the systemic circulation, rendering it a potentially valuable bio-fluid for diagnoses.

Several types of inflammatory biomarkers associated with oral diseases, as well as systemic diseases, have been detected in saliva. Cytokines are among the most investigated biomarkers in this context. Due to their involvement in inflammatory, infectious and immunological diseases, cytokines may serve as markers of local oral pathologies such as periodontal disease and carries. Indeed, in adults, evidence shows that such disease can be detected through saliva biomarkers such as interleukins (IL)-1b, -6, -8 and -10), tumor necrosis factor- α (TNF- α) and matrix metalloproteinases (MMP)-8 and -9 in adults. Additionally, as some etiologies of oral pathology as gingivitis include bacterial infection such as Streptococcus, Fusobacterium, Actinomyces, Veillonella, Treponema, Capnocytophaga and Eikenella, saliva may also be used to measure bacterial load.

Dental caries is one of the most common childhood diseases worldwide, and is associated with polymicrobial colonization on tooth surfaces. Both acidogenic and aciduric bacteria, such as the Mutans group of Streptococci and Lactobacilli, are primary etiological agents of dental caries. Lactobacilli and S. Mutans are mostly found together in saliva . The diversity of microbes in saliva has been shown to increase in the caries active status. In children with cavitated carious lesions, altered concentrations of the cytokines IL-6 and IL-8 were reported.

The objective of this study was to characterize the inflammatory and microbiological profile of the saliva of healthy children, and to associate those levels with clinical diagnosis of caries and gingival disease.

Materials and methods Study population The study population comprised 100 participants, born during 2008-2016 (aged 4-12 years at the time of the study).

Clinical oral examination

Dental examinations were conducted by two dental students using a dental mirror, dental explorer and dental probe, and included the following parameters:

  • Oral hygiene - measured by the plaque index (PI), as described previously,18 only on buccal surfaces.
  • Periodontal status - measured by the gingival index (GI), as described previously
  • Caries status measured by the DMFT/ dmft index (D=decay, M=missing, F=filling; T per tooth) in permanent/ primary dentition . All the values were collected and recorded in a data table.

Saliva collection Saliva was collected in a quiet room between 0800 and 1230 hr. The children were asked to collect saliva in their mouths and to spit it into a wide test tube for 3 min. The saliva was immediately stored at 4°C and further kept at -80°C until analysis. Data were collected onto paper charts, which were transferred to a computer program.

Bacteria testing Bacterial DNA was extracted from saliva using DNA extraction kit (Qiagen). The DNA was then tested using specific primers for total bacteria: Strep. Mutans, Lactobacillus and Fusobacterium nucleatum using quantitative real-time polymerase chain reaction.

Salivary cytokine quantification Salivary levels of human TNF- α, IL-10, IL-8, and IL-6 were measured using ELISA kits according to manufacturer instructions (R\&D systems, Minneapolis, MN, US). The saliva samples were transferred to the periodontal laboratory in Hadassah Ein Kerem Hospital for analysis. The ELISA method works by a cytokine carbonate-specific monoclonal antibody placed in a 96-well plate. After dilution of µL 83 saliva to 10 ml PBS of antibody capture, the active solution is placed with the antibody in the well, and covered overnight at room temperature. Subsequently, we wash with µL 400 (buffer wash) and repeat this step three times. We then block the wells by adding µL 300 diluent reagent for one hour at room temperature, and wash again as described above. We dilute at 100 µL, cover and incubate for 2 hours at room temp. We then rinse again, and add detection antibody at a concentration of 166 µL to 10 ml, cover and incubate for 2 hours. Next, we add biotin-related antibody, followed by HRP-streptavidin conjugate, and TMB as a substrate. The reaction is stopped by acid sulfuric and quantified using 650nm-OD490.

Statistical analysis All the experiments were performed in triplicate. The data were stratified according to age, DMF, PI and GI. Three age groups were set according to dental age: primary dentition - ages 0-6 years; mixed dentition - ages 6-11 years; and permanent dentition - above age 11 years. DMFT was stratified by ≤2 and >2. The PI was stratified by ≤1 and >1. GI was stratified by equal to zero versus above zero. The data were analysed using a statistical software package (SigmaStat, Jandel Scientific, San Rafael, CA, USA). One-way repeated measure analysis of variance (RM ANOVA) was applied to test the significance of the differences between the treated groups. When significant results were found, inter-group differences were tested for significance using the Student's t-test and the Bonferroni correction for multiple testing. Statistical significance was set at p<0.05.

Conditions
Healthy
Keywords
cytokines, saliva, gingivitis
Medical subject headings
Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05495373
Study groupRoleWhat they receive
healthy caseshealthy children at ages between 4-12

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral hygiene

    measured by the plaque index (PI)

    Measured: at screening visit

  2. Periodontal status

    measured by the gingival index (GI)

    Measured: at screening visit

  3. Caries status

    DMFT/ dmft index (D=decay, M=missing, F=filling; T per tooth) in permanent/ primary dentition

    Measured: at screening visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2022
  2. Study start1 Jan 2020
  3. Primary completion1 Jan 2022
  4. Study completion1 Feb 2022

Resources

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 only
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05495373
Sponsor's protocol ID
HMO-067617
Status last verified
Aug 2022
First submitted
18 Jul 2022
Last updated
10 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Hadassah Medical Organization at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 10 Aug 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 Israel. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral hygiene (time frame: at screening visit). The study lists 3 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 10 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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