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

Study Overview
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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

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

Conditions
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Prevention of Dental Caries

Intervention / Treatment
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* Other: dual Zinc plus Arginine based toothpaste (Colgate total)
* Other: Zinc based toothpaste (Crest complete)
* Other: Fluoride based toothpaste (Signal)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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