Back to resultsNovamin on Streptococcus Mutans Count in Dental Plaque of High Caries Risk Children
Primary Purpose
Dental Plaque, Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Novamin containing toothpaste
Fluoride containing toothpaste
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque
Eligibility Criteria
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
Sites / Locations
- Alexandria Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05979636
Brief Title
Novamin on Streptococcus Mutans Count in Dental Plaque of High Caries Risk Children
Official Title
Effect of Toothpaste Containing Novamin on Streptococcous Mutans Count in Dental Plaque of High Caries Risk Children (Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Novamin containing toothpaste
Intervention Description
children's teeth will be brushed using Novamin containing toothpaste.
Intervention Type
Other
Intervention Name(s)
Fluoride containing toothpaste
Intervention Description
children's teeth will be brushed using Fluoride containing toothpaste.
Primary Outcome Measure Information:
Title
Change in bacterial count in dental plaque
Description
The samples will be collected from all children in the study and the level of S.mutans will be recorded.
Time Frame
1 week, 2 weeks and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Novamin on Streptococcus Mutans Count in Dental Plaque of High Caries Risk Children
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