CariesNCT03906981
Dental Plaque Microbiota in Caries-free and Caries-active Children
An observational study of Caries and Plaque, run by Kuwait University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Apr 2019
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pupils from randomly selected public schools
Who may be able to join
- Arab 6-9 year old children
- Healthy
- Caries free, dmft/DMFT=0
- Caries Active: dmft/DMFT>5
Who cannot join
- 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.
About this study
Official title: Dental Plaque Microbiota in Caries-free and Caries-active Arab Children
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.
Read the detailed description
The objective of this study will be to investigate the dental plaque's microbial diversity using Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) technology in the mixed dentition as well as the levels of salivary proteins in caries-free compared with caries active Arab children. The study protocol was approved by the Health Science Center Ethical Committee at Kuwait University.
One hundred 6-9 year-old children with caries active and caries-free status will be recruited from randomly selected public schools in Kuwait. After DNA purification from supragingival plaque samples, HOMINGS will be performed. To get an insight into the host factors involved in this complex interplay between the host and the bacteria, stimulated saliva from the study subjects will be analyzed by proteomics. For children in both groups supragingival plaque samples will be collected from the buccal and lingual surfaces of all teeth. After preparing the samples, the aliquots of purified DNA samples will be shipped to The Forsyth Institute for Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) protocol.
- Being tested
- Plaque from each subject will be collected but there will be no intervention
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaque from each subject will be collected but there will be no interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Caries free | 6-9 year old caries free children Receives: 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 Receives: Other: Plaque from each subject will be collected but there will be no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental plaque microbiota profile
Identification of dental plaque microbiota profile using HOMINGS
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start1 Jan 2016
- Primary completion1 Mar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuwait University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muawia A. Qudeimat, Kuwait University
- Investigators
- Muawia A Qudeimat, MDentSci, Principal investigator, Kuwait University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906981
- Sponsor's protocol ID
- DD01/14
- Status last verified
- Sep 2019
- First submitted
- 5 Apr 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Plaque Microbiota in Caries-free and Caries-active Arab Children
- ClinicalTrials.gov ID
- NCT03906981
- Acronym / sponsor ID
- DD01/14
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kuwait UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 8 Apr 2019 (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.
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.
Detailed description
The objective of this study will be to investigate the dental plaque's microbial diversity using Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) technology in the mixed dentition as well as the levels of salivary proteins in caries-free compared with caries active Arab children. The study protocol was approved by the Health Science Center Ethical Committee at Kuwait University.
One hundred 6-9 year-old children with caries active and caries-free status will be recruited from randomly selected public schools in Kuwait. After DNA purification from supragingival plaque samples, HOMINGS will be performed. To get an insight into the host factors involved in this complex interplay between the host and the bacteria, stimulated saliva from the study subjects will be analyzed by proteomics. For children in both groups supragingival plaque samples will be collected from the buccal and lingual surfaces of all teeth. After preparing the samples, the aliquots of purified DNA samples will be shipped to The Forsyth Institute for Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caries free | – | Other: Plaque from each subject will be collected but there will be no intervention6-9 year old caries free children |
| Caries active | – | Other: Plaque from each subject will be collected but there will be no intervention6-9 year-old caries active (>5 dmft/DMFT) children |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pupils from randomly selected public schools
Key inclusion criteria (4 listed)
- Arab 6-9 year old children
- Healthy
- Caries free, dmft/DMFT=0
- Caries Active: dmft/DMFT>5
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Plaque from each subject will be collected but there will be no interventionNo intervention | Other | Caries active, Caries free |
Primary outcome
Dental plaque microbiota profile
Time frame: 2 months
Identification of dental plaque microbiota profile using HOMINGS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Muawia A Qudeimat, MDentSci principal investigator
Kuwait University
Questions about this trial
What is this clinical trial studying?
An observational study of Caries and Plaque, run by Kuwait University.
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 4 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: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Dental plaque microbiota profile (time frame: 2 months). 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 25 Sep 2019.