NCT05979636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2022

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

26 days

First QC Date

July 29, 2023

Last Update Submit

July 29, 2023

Conditions

Dental PlaqueDental Caries

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Test group

EXPERIMENTAL
Other: Novamin containing toothpaste

Control group

ACTIVE COMPARATOR
Other: Fluoride containing toothpaste

Interventions

Novamin containing toothpasteOTHER

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

Test group
Fluoride containing toothpasteOTHER

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

Control group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Dental PlaqueDental Caries

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesTooth Demineralization

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

July 29, 2023

First Posted

August 7, 2023

Study Start

December 6, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

August 7, 2023

Record last verified: 2023-07

Locations

EG(1)