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

Sponsor

Hams Hamed Abdelrahman (Other)

Overall Status

Completed

CT.gov ID

NCT05979636

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

42.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Plaque Dental Caries	Other: Novamin containing toothpaste Other: Fluoride containing toothpaste	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 6, 2022

Actual Primary Completion Date :

Jan 1, 2023

Actual Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Test group

Other: Novamin containing toothpaste

children's teeth will be brushed using Novamin containing toothpaste.

Active Comparator: Control group

Other: Fluoride containing toothpaste

children's teeth will be brushed using Fluoride containing toothpaste.

Outcome Measures

Primary Outcome Measures

Change in bacterial count in dental plaque [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Dentistry	Alexandria		Egypt

Sponsors and Collaborators

Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University

ClinicalTrials.gov Identifier:

NCT05979636

Other Study ID Numbers:

0286-09/2021

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Dental Plaque

Fluorides

Study Results

No Results Posted as of Aug 7, 2023