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

July 24, 2019 updated by: Esraa Abdel Ghaffar Ahmed Ali, Cairo University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regimen using dual Zinc plus Arginine based toothpaste
Other: dual Zinc plus Arginine based toothpaste (Colgate total)
Regimen using dual Zinc plus Arginine based toothpaste (Colgate total)
Experimental: Regimen using Zinc based toothpaste (Crest complete)
Other: Zinc based toothpaste (Crest complete)
Regimen using Zinc based toothpaste (Crest complete)
Active Comparator: Fluoride based toothpaste (Signal)
Other: Fluoride based toothpaste (Signal)
Fluoride based toothpaste (Signal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
caries risk assessment
Time Frame: Three months
will be evaluated by cariogram
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DMF score
Time Frame: 12 months
will be evaluated by ICDAS
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

July 23, 2019

First Posted (Actual)

July 25, 2019

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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