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NCT05979636 Clinical Trial

Novamin on Streptococcus Mutans Count in Dental Plaque of High Caries Risk Children

Dental Caries Clinical Trial

Official title:
Effect of Toothpaste Containing Novamin on Streptococcous Mutans Count in Dental Plaque of High Caries Risk Children (Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05979636
Other study ID # 0286-09/2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 6, 2022
Est. completion date January 1, 2023

Study information
Verified date July 2023
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Inhibition of streptococcus mutans can be effective to prevent caries in high caries-risk children. The aim of the study is to evaluate the effect of Novamin on streptococcus mutans in the plaque of high caries-risk children.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria: - Medically healthy children. - No erupting first permanent molars. - High caries risk children; Have visible cavities or have a visible plaque on their teeth. - Cooperative (Positive or definitely positive), according to Frankl's Behavior Rating Scale Exclusion Criteria: - History of intake of antibiotics for the past 3-4 weeks. - History of professional fluoride treatment over 2 weeks before the study. - Children with tooth structure defects. - Children unable to return for recall visits

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Novamin containing toothpaste
children's teeth will be brushed using Novamin containing toothpaste.
• Fluoride containing toothpaste
children's teeth will be brushed using Fluoride containing toothpaste.

Locations
Country Name City State
Egypt Alexandria Faculty of Dentistry Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in bacterial count in dental plaque The samples will be collected from all children in the study and the level of S.mutans will be recorded. 1 week, 2 weeks and 4 weeks
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