NCT05495373

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

July 18, 2022

Last Update Submit

August 8, 2022

Conditions

Healthy

Keywords

cytokinessalivagingivitis

Outcome Measures

Primary Outcomes (3)

  • Oral hygiene

    measured by the plaque index (PI)

    at screening visit

  • Periodontal status

    measured by the gingival index (GI)

    at screening visit

  • Caries status

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

    at screening visit

Study Arms (1)

healthy cases

healthy children at ages between 4-12

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • david polak

    Hadassah Medical Organization

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 18, 2022

First Posted

August 10, 2022

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

August 10, 2022

Record last verified: 2022-08

Locations

IL(1)