Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults

Study Overview
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Brief Summary
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Basic standard of care emphasis only tooth brushing and flossing without addressing individual pathological factors. For this reason, randomized controlled clinical trials on personalized caries management are needed to be able to compare the effectiveness of personalized caries management to basic standard of care. This is especially true in high caries risk populations and more so for young adults who stand to benefit the most from working towards a caries free adulthood.

Detailed Description
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Aim of the study: is to conduct an RCT to compare the effectiveness of a new personalized caries-control treatment protocol with standard caries treatment protocol for reducing caries incidence in high caries risk patients Hypothesis: This project will be designed to test the null hypothesis that there is no significant difference between the new personalized caries-control treatment protocol and existing standard caries treatment protocol, and to test the alternative hypothesis that the new personalized treatment protocol will be superior to the standard preventive measures Primary objective: is to measure the incidence of new caries lesions

Official Title
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Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults: A Randomized Controlled Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Personalized Treatment
* Other: Chlorhexidine and Remineralization
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High caries risk patients 18-25 years Males or Females Patients approving to participate in the study - Exclusion Criteria: Patients with systemic conditions Current periodontitis (sites of probing pocket depth ≥ 5 mm) Allergy to any of the ingredients of the study products Evidence of parafunctional habits Dysfunction of temporomandibular joint Use of antibiotics in the previous 30 days Patients with developmental dental anomalies Patients with removable prosthesis Patients with Orthodontic appliance Periapical Abscess or Fistula and exposed pulps.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Personalized Treatment<br>Intervention by (standard preventive measures + targeting individual caries risk factors) | Other: Personalized Treatment<br>* Targeting individual caries risk factors<br>|
| Experimental: Chlorhexidine and Rremineralization<br>Intervention is (chlorhexidine + Remineralizing agent + standard preventive measures) | Other: Chlorhexidine and Remineralization<br>* chlorhexidine mouth wash and remineralizing agent<br>|
| Active Comparator: Control<br>standard preventative measures (tooth brushing, fluoride tooth paste, interdental cleaning) | Other: Control<br>* Control is standard preventive measures (tooth brushing, fluoride tooth paste, interdental cleaning)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of new caries lesions | incidence of new caries lesions | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caries, prevention, personalized medicine