NCT03906981

Brief Summary

Dental caries is a polymicrobial infection originally thought to be caused by Streptococcus mutans and Lactobacilli. However, unprecedented developments in modern molecular techniques have demonstrated that several microbial species are associated with the disease in addition to streptococci and lactobacilli. Dental caries initiation and progression is a dynamic process in which demineralization of the tooth structure, as a result of acid production from acidogenic bacteria (due to carbohydrate metabolism) is being counteracted by the remineralization of the tooth surface by strong alkali production by certain bacteria in the dental biofilm. The aim of the present study is to identify the different microbiota in the oral biofilm using new laboratory techniques as well as the levels of salivary proteins in caries-free compared with caries active Arab children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

3.2 years

First QC Date

April 5, 2019

Last Update Submit

September 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dental plaque microbiota profile

    Identification of dental plaque microbiota profile using HOMINGS

    2 months

Study Arms (2)

Caries free

6-9 year old caries free children

Other: Plaque from each subject will be collected but there will be no intervention

Caries active

6-9 year-old caries active (\>5 dmft/DMFT) children

Other: Plaque from each subject will be collected but there will be no intervention

Interventions

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pupils from randomly selected public schools

You may qualify if:

  • Arab 6-9 year old children
  • Healthy
  • Caries free, dmft/DMFT=0
  • Caries Active: dmft/DMFT\>5

You may not qualify if:

  • Children with a systemic disease or any drug use that could affect the microflora of the oral cavity or the salivary gland functions
  • History of salivary gland diseases
  • Those who received antibiotic therapy during the last 3 months
  • Children with severe localized or generalized periodontitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Plaque sample from each subject

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Muawia A Qudeimat, MDentSci

    Kuwait University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 8, 2019

Study Start

January 1, 2016

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09