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

July 29, 2023 updated by: Hams Hamed Abdelrahman

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Other: Fluoride containing toothpaste
children's teeth will be brushed using Fluoride containing toothpaste.
Experimental: Test group
Other: Novamin containing toothpaste
children's teeth will be brushed using Novamin containing toothpaste.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bacterial count in dental plaque
Time Frame: 1 week, 2 weeks and 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

July 29, 2023

First Submitted That Met QC Criteria

July 29, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

July 29, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0286-09/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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