Evaluation of the Salivary-free Amino Acids Levels (Glyci... | NCT06953557

Studies
Evaluation of the Salivary-free Amino Acids Levels (Glycine , Proline , Lysine , and Alanine ) With Caries Activity

NCT06953557

Sponsor

Al-Mustansiriyah University

Status

Not yet recruiting

Last Update Posted

May 1, 2025Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Dental Caries

Interventions

To compare the effect of salivary glycine , proline , lysine and alanine concentration between participants with high caries activity and participants with negative caries activity

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2025Estimated

Primary Completion Date

May 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Apr 15, 2025

First Submission Date that Met QC Criteria

Apr 23, 2025

First Posted Date

May 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2025

Last Update Posted Date

May 1, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abeer Ibrahim Mohammed, Princible investigator, Al-Mustansiriyah UniversityPrincipal Investigator

Lead Sponsor

Al-Mustansiriyah UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
To compare the effect of salivary glycine , proline , lysine and alanine concentration between participants with high caries activity and participants with negative caries activity	Diagnostic Test	The investigators will measure Salivary-free amino acids by using reverse phase high performance liquid chromatography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Salivary-free amino acid analysis	Unstimulated saliva collection for salivary free amino acids analysis	Baseline :unstimulated saliva collection for salivary glycine , proline , lysine and alanine measurement

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged (8,9,10) years with different caries
Absence of signs of gingivitis or periodontal disease.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Children in both genders in 8-10 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abeer Ibrahim Mohammed, B.D.S	Contact	+9647709497799		abeeribrahim93@uomustansiriyah.edu.iq

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases