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Molecular Assessment of Oral Mutans Streptococcus Isolated From Different Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802669
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Naglaa Ibrahim Ezz, October University for Modern Sciences and Arts

Tracking Information
First Submitted Date January 10, 2019
First Posted Date January 14, 2019
Last Update Posted Date September 17, 2019
Actual Study Start Date January 12, 2019
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 10, 2019)
oral mutans streptococcus screening [ Time Frame: immediately ]
screening of oral mutans streptococcus of each group to determine the differences
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Assessment of Oral Mutans Streptococcus Isolated From Different Patients
Official Title Molecular Assessment of Oral Mutans Streptococcus Isolated From Patients With Different Age and Caries Activity Via Selective Media and Protein Pattern.
Brief Summary 90 saliva samples will be isolated from patient who possess different ages and caries activity, attending outpatient clinic of October University of Modern Sciences and Arts. Then the determination of the best selective media for mutans streptococcus isolated from saliva and authenticate the MS via PCR technique.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients attending out patient clinic of October University for Modern Sciences and Arts.
Condition Dental Caries
Intervention Other: oral mutans streptococcus
quantitative assessment of mutans streptococcus of each group by using PCR and protein pattern
Study Groups/Cohorts
  • caries free children aged between 3-6
    Intervention: Other: oral mutans streptococcus
  • caries active children aged between 3-6
    Intervention: Other: oral mutans streptococcus
  • caries free children aged between 6-12
    Intervention: Other: oral mutans streptococcus
  • caries active children aged between 6-12
    Intervention: Other: oral mutans streptococcus
  • caries free adult aged between 18-25
    Intervention: Other: oral mutans streptococcus
  • caries active adult aged between 18-25
    Intervention: Other: oral mutans streptococcus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2019)
90
Original Estimated Enrollment
 (submitted: January 10, 2019)
120
Actual Study Completion Date May 20, 2019
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • healthy participant

Exclusion Criteria:

  • participant received antimicrobial therapy in previous month.
  • participant who taking xylitol chewing gum or undergo fluoride therapy.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03802669
Other Study ID Numbers ETH10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Naglaa Ibrahim Ezz, October University for Modern Sciences and Arts
Study Sponsor October University for Modern Sciences and Arts
Collaborators Not Provided
Investigators
Principal Investigator: Naglaa Ezzeldin, lecturer October University for Modern Sciences and Arts
PRS Account October University for Modern Sciences and Arts
Verification Date September 2019