Antibacterial Effect of Miswak Toothpaste Compared to Flu... | NCT05109299

Studies
Antibacterial Effect of Miswak Toothpaste Compared to Fluoride Toothpaste

NCT05109299

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Nov 5, 2021Actual

Enrollment

32Estimated

Phase

Not Applicable

Conditions

Caries

Interventions

Miswak toothpaste
Fluoride 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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Estimated

Primary Completion Date

Mar 30, 2022Estimated

Completion Date

Apr 30, 2022Estimated

First Submitted Date

Oct 15, 2021

First Submission Date that Met QC Criteria

Oct 26, 2021

First Posted Date

Nov 5, 2021Actual

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

Oct 26, 2021

Last Update Posted Date

Nov 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Omar Osama Shaalan, Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Meswak is scientifically formulated herbal toothpaste with pure extract of the Miswak plant 'Salvadore Persica', the famous 'Toothbrush Tree' used for centuries. The astringent and anti-bacterial properties of Meswak helps reduce tooth decay , fight plaque and prevent gum diseases. Miswak Herb is a rare, potent, priceless, wonder herb that delivers incredible Dental Care benefits.

Detailed Description

This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate antibacterial effect miswak toothpaste compared to fluoride toothpaste in high caries risk patients.

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

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Miswak toothpaste	Experimental	Dabur meswak herpal toothpaste	Other: Miswak toothpaste
Fluoride toothpaste	Active Comparator	Signal fluoride toothpaste, containing 1450 ppm of fluoride	Other: Fluoride toothpaste

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Miswak toothpaste	Other	Dabur Meswak is scientifically formulated herbal toothpaste with pure extract of the Miswak plant 'Salvadore Persica'	Miswak toothpaste

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
streptococcus mutans count	Counting streptococcus mutans, Measurement: Mitis-Salivarius agar plate, Unit: CFUs/mL	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

High caries risk patients.
At least one carious tooth according to CAT caries risk assessment model.
Patient compliance

Exclusion Criteria:

Participant in another trial.
Using another antimicrobial agents since one month of sampling.
Systemic diseases or concomitant medication affecting salivary flow.
Parafunctional habits.
Pregnancy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Omar O Shaalan, PhD	Contact	00201122665661		omar.shaalan@dentistry.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Omar O Shaalan, PhD	Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry, Cairo University		Cairo	El Manial	11553	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided