CompletedNCT05979636Updated Aug 7, 2023

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

An interventional study of Novamin containing toothpaste and Fluoride containing toothpaste in Dental Plaque and Dental Caries, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2023-08-07.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Prevention

From the registry’s dates

Registered 7 months after the study started (first participant enrolled Dec 2022, registered Jul 2023).

Phase: Not applicable
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 3 Years to 6 Years
Sex: All

Study 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.

Conditions studied

Dental Plaque
Dental Caries

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In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 36 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

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Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 3 Years to 6 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 36 participants (actual)

Study arms

Experimental
Test group
Other: Novamin containing toothpaste
Active comparator
Control group
Other: Fluoride containing toothpaste

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 1 week, 2 weeks and 4 weeks

Study locations

1 site

Alexandria Faculty of Dentistry
Alexandria, Egypt

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05979636
Lead sponsor: Hams Hamed Abdelrahman
Responsible party: Hams Hamed Abdelrahman (Assistant lecturer of DPH and Clinical statistician, Alexandria University) — Sponsor-investigator
First posted: Aug 7, 2023
Start date: Dec 6, 2022
Primary completion: Jan 1, 2023
Completion: Jan 1, 2023
Last update: Aug 7, 2023

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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