Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control 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 exposed to fluoride toothpaste, (A2) represents participants exposed to regimen including fluoride toothpaste and chlorhexidine mouthwash and (A3) represents participants exposed to regimen including fluoride toothpaste, chlorhexidine mouthwash and MI fluoride varnish. 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: T2). In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T1), third visit (after 6 months: T2) and final visit (after 12 months: T3) to obtain the required data

Official Title
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Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial

Conditions
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Prevention of Dental Caries

Intervention / Treatment
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* Other: Fluoride toothpaste
* Other: fluoride toothpaste and chlorhexidine mouthwash
* Other: fluoride toothpaste, chlorhexidine mouthwash, MI varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 20-50 years High caries risk patients defined according to cariogram caries risk assessment model On non-cariogenic diet High plaque index Systematically healthy No orthodontic or prosthodontic appliance Exclusion Criteria: Age range less than 20 or more than 50 years Low or moderate caries risk patients according to cariogram Patients with a compromised medical history Cariogenic diet patient 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 |
| --- | --- |
| Active Comparator: Fluoride toothpaste<br> | Other: Fluoride toothpaste<br>* regimen using fluoride toothpaste<br>|
| Experimental: fluoride toothpaste and chlorhexidine mouthwash<br> | Other: fluoride toothpaste and chlorhexidine mouthwash<br>* regimen using fluoride toothpaste and chlorhexidine mouthwash<br>|
| Experimental: fluoride toothpaste, chlorhexidine mouthwash, MI varnish<br> | Other: fluoride toothpaste, chlorhexidine mouthwash, MI varnish<br>* regimen using fluoride toothpaste, chlorhexidine mouthwash, MI varnish<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 | an average 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DMF scores | will be evaluated by ICDAS | an average of 12 months |