Dental CariesNCT06953557
Evaluation of the Salivary-free Amino Acids Levels (Glycine , Proline , Lysine , and Alanine ) With Caries Activity
An observational study of Dental Caries, run by Al-Mustansiriyah University.
Trial summary
This study will be aimed to investigated the correlation between levels of salivary amino acids (glycine , proline , lysine , alanine ) in the saliva of healthy children with and without active carious lesions and to estimate the predictive capacity of caries susceptibility Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- To compare the effect of salivary glycine , proline , lysine and alanine concentration between participants with high caries activity and participants with negative caries activity
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children in both genders in 8-10 years old
Who may be able to join
- Children aged (8,9,10) years with different caries
- Absence of signs of gingivitis or periodontal disease.
Who cannot join
- Children out the range of age
- Children with any systemic discases.
- Children with appliances in the mouth.
- Children with appliances in the mouth.
- Children with antibiotic treatment or any other drug over the last two weeks. B
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Salivary-free Amino Acids Levels With Caries Activity
This study will be aimed to investigated the correlation between levels of salivary amino acids (glycine , proline , lysine , alanine ) in the saliva of healthy children with and without active carious lesions and to estimate the predictive capacity of caries susceptibility
Read the detailed description
80 healthy children (8-10 years old) will be recruited from primary schools of Baghdad city/ Iraq, will be classified according to their level of caries activity (high caries activity, n = 40; negative caries activity, n = 40). Total stimulated and unstimulated saliva will be collected to estimate the caries activity by using the Snyder test, and Amino acid analysis of the saliva will be performed by reversed phase - high performance liquid chromatography (RP-HPLC), respectively.
- Conditions
- Dental Caries
- Being tested
- To compare the effect of salivary glycine , proline , lysine and alanine concentration between participants with high caries activity and participants with negative caries activity
- Keywords
- Salivary -free amino acid measurment
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To compare the effect of salivary glycine , proline , lysine and alanine concentration between participants with high caries activity and participants with negative caries activityDiagnostic test
The investigators will measure Salivary-free amino acids by using reverse phase high performance liquid chromatography
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary-free amino acid analysis
Unstimulated saliva collection for salivary free amino acids analysis
Measured: Baseline :unstimulated saliva collection for salivary glycine , proline , lysine and alanine measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start30 Apr 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ibrahim Mohammed, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953557
- Sponsor's protocol ID
- Mustansiriyah
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- 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 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Salivary-free Amino Acids Levels With Caries Activity
- ClinicalTrials.gov ID
- NCT06953557
- Acronym / sponsor ID
- Mustansiriyah
- Conditions
- Dental Caries
- Keywords
- Salivary -free amino acid measurment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 May 2025 (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.
This study will be aimed to investigated the correlation between levels of salivary amino acids (glycine , proline , lysine , alanine ) in the saliva of healthy children with and without active carious lesions and to estimate the predictive capacity of caries susceptibility
Detailed description
80 healthy children (8-10 years old) will be recruited from primary schools of Baghdad city/ Iraq, will be classified according to their level of caries activity (high caries activity, n = 40; negative caries activity, n = 40). Total stimulated and unstimulated saliva will be collected to estimate the caries activity by using the Snyder test, and Amino acid analysis of the saliva will be performed by reversed phase - high performance liquid chromatography (RP-HPLC), respectively.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children in both genders in 8-10 years old
Key inclusion criteria (2 listed)
- Children aged (8,9,10) years with different caries
- Absence of signs of gingivitis or periodontal disease.
Key exclusion criteria (5 listed)
- Children out the range of age
- Children with any systemic discases.
- Children with appliances in the mouth.
- Children with appliances in the mouth.
- Children with antibiotic treatment or any other drug over the last two weeks. B
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 |
|---|---|---|
| To compare the effect of salivary glycine , proline , lysine and alanine concentration between participants with high caries activity and participants with negative caries activityThe investigators will measure Salivary-free amino acids by using reverse phase high performance liquid chromatography | Diagnostic test | – |
Primary outcome
Salivary-free amino acid analysis
Time frame: Baseline :unstimulated saliva collection for salivary glycine , proline , lysine and alanine measurement
Unstimulated saliva collection for salivary free amino acids analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by Al-Mustansiriyah 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abeer Ibrahim Mohammed, B.D.S (+9647709497799, abeeribrahim93@uomustansiriyah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary-free amino acid analysis (time frame: Baseline :unstimulated saliva collection for salivary glycine , proline , lysine and alanine measurement). 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 1 May 2025.