Novamin on Streptococcus Mutans Count in Dental Plaque of... | NCT05979636

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

NCT05979636

Sponsor

Hams Hamed Abdelrahman

Status

Completed

Last Update Posted

Aug 7, 2023Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Dental Plaque
Dental Caries

Interventions

Novamin containing toothpaste
Fluoride containing toothpaste

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 6, 2022Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Jan 1, 2023Actual

First Submitted Date

Jul 29, 2023

First Submission Date that Met QC Criteria

Jul 29, 2023

First Posted Date

Aug 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2023

Last Update Posted Date

Aug 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria UniversitySponsor-Investigator

Lead Sponsor

Hams Hamed AbdelrahmanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group	Experimental		Other: Novamin containing toothpaste
Control group	Active Comparator		Other: Fluoride containing toothpaste

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Novamin containing toothpaste	Other	children's teeth will be brushed using Novamin containing toothpaste.	Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandria Faculty of Dentistry		Alexandria			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D003773	Dental Plaque
D003731	Dental Caries

Ancestor Terms

ID	Term
D003741	Dental Deposits
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D017001	Tooth Demineralization

Browse Leaves

Not provided

Browse Branches

Not provided