The Influence of Preventive Regimens Containing Different Toothpastes on Caries Risk of High Risk Patients: A Randomized Clinical Trial

NCT ID: NCT04032210

Last Updated: 2019-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-11-01

Brief Summary

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66 Participants will be divided into three groups according to the tested regimen (A), where (A1) represents participants will be exposed to regimen including dual zinc plus arginine based toothpaste (Colgate total), (A2) represents participants will be exposed to regimen including zinc based toothpaste (Crest complete) and (A3) represents control group where participants will be used fluoride based toothpaste (Signal). The study will be carried over a period of one year, assessment of cariogram will be done in two visits: first visit (baseline: T0) and second visit (after 3 months: T3) . In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T3), third visit (after 6 months: T6) and final visit (after 12 months: T12) to obtain the required data

Detailed Description

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Conditions

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Prevention of Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Regimen using dual Zinc plus Arginine based toothpaste

Group Type EXPERIMENTAL

dual Zinc plus Arginine based toothpaste (Colgate total)

Intervention Type OTHER

Regimen using dual Zinc plus Arginine based toothpaste (Colgate total)

Regimen using Zinc based toothpaste (Crest complete)

Group Type EXPERIMENTAL

Zinc based toothpaste (Crest complete)

Intervention Type OTHER

Regimen using Zinc based toothpaste (Crest complete)

Fluoride based toothpaste (Signal)

Group Type ACTIVE_COMPARATOR

Fluoride based toothpaste (Signal)

Intervention Type OTHER

Fluoride based toothpaste (Signal)

Interventions

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dual Zinc plus Arginine based toothpaste (Colgate total)

Regimen using dual Zinc plus Arginine based toothpaste (Colgate total)

Intervention Type OTHER

Zinc based toothpaste (Crest complete)

Regimen using Zinc based toothpaste (Crest complete)

Intervention Type OTHER

Fluoride based toothpaste (Signal)

Fluoride based toothpaste (Signal)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* • Normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.

* Subjects of mean age 20-50 years.
* Patients with high caries risk assessment according to Cariogram.
* Non cariogenic diet patient
* High plaque index
* Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study.

Exclusion Criteria

* • Patients with a compromised medical history.

* Cariogenic diet patient.
* Participants with severe or active periodontal disease.
* Participants with a history of allergy to any of the drugs or chemicals used in the study.
* Patients on any antibiotics during the past month
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Esraa Abdel Ghaffar Ahmed Ali

resident of conservative department of faculty of oral and dental medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Esraa Abdel Ghaffar Ahmed

Giza, Other, Egypt

Site Status

Countries

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Egypt

Central Contacts

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esraa A ahmed, phD

Role: CONTACT

00201020614170

howaida f foad, phD

Role: CONTACT

00201010008948

Facility Contacts

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esraa A ahmed, phD

Role: primary

00201020614170

howaida f foad, phD

Role: backup

00201010008948

Other Identifiers

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2230

Identifier Type: -

Identifier Source: org_study_id

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