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

Primary Purpose

Prevention of Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
dual Zinc plus Arginine based toothpaste (Colgate total)
Zinc based toothpaste (Crest complete)
Fluoride based toothpaste (Signal)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Dental Caries

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Esraa Abdel Ghaffar Ahmed

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Regimen using dual Zinc plus Arginine based toothpaste

Regimen using Zinc based toothpaste (Crest complete)

Fluoride based toothpaste (Signal)

Arm Description

Outcomes

Primary Outcome Measures

caries risk assessment
will be evaluated by cariogram

Secondary Outcome Measures

DMF score
will be evaluated by ICDAS

Full Information

First Posted
July 23, 2019
Last Updated
July 24, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04032210
Brief Title
The Influence of Preventive Regimens Containing Different Toothpastes on Caries Risk of High Risk Patients: A Randomized Clinical Trial
Official Title
The Influence of Preventive Regimens Containing Different Toothpastes on Caries Risk of High Risk Patients: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regimen using dual Zinc plus Arginine based toothpaste
Arm Type
Experimental
Arm Title
Regimen using Zinc based toothpaste (Crest complete)
Arm Type
Experimental
Arm Title
Fluoride based toothpaste (Signal)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
dual Zinc plus Arginine based toothpaste (Colgate total)
Intervention Description
Regimen using dual Zinc plus Arginine based toothpaste (Colgate total)
Intervention Type
Other
Intervention Name(s)
Zinc based toothpaste (Crest complete)
Intervention Description
Regimen using Zinc based toothpaste (Crest complete)
Intervention Type
Other
Intervention Name(s)
Fluoride based toothpaste (Signal)
Intervention Description
Fluoride based toothpaste (Signal)
Primary Outcome Measure Information:
Title
caries risk assessment
Description
will be evaluated by cariogram
Time Frame
Three months
Secondary Outcome Measure Information:
Title
DMF score
Description
will be evaluated by ICDAS
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
esraa A ahmed, phD
Phone
00201020614170
Email
ososdent@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
howaida f foad, phD
Phone
00201010008948
Email
howaidafakhry@gmail.com
Facility Information:
Facility Name
Esraa Abdel Ghaffar Ahmed
City
Giza
State/Province
Other
ZIP/Postal Code
8655
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
esraa A ahmed, phD
Phone
00201020614170
Email
ososdent@hotmail.com
First Name & Middle Initial & Last Name & Degree
howaida f foad, phD
Phone
00201010008948
Email
howaidafakhry@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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