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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Treatment | Experimental | Intervention by (standard preventive measures + targeting individual caries risk factors) |
|
| Chlorhexidine and Rremineralization | Experimental | Intervention is (chlorhexidine + Remineralizing agent + standard preventive measures) |
|
| Control | Active Comparator | standard preventative measures (tooth brushing, fluoride tooth paste, interdental cleaning) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Treatment | Other | Targeting individual caries risk factors |
| |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of new caries lesions | incidence of new caries lesions | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| sherif khadr, Msc | Contact | +201007777939 | sherifkhadr@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fawzi, PhD | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
Data will be made available after publication upon request
12 month after publication , data will be available upon request
principal investigator to be contacted by email for data access
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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The recruiter will be blinded. The operator cannot be blinded because of the different in the procedures of caries prevention applied in each group. However, the assessors will be kept unaware of the treatment assigned to the patient.
| Chlorhexidine and Remineralization |
| Other |
chlorhexidine mouth wash and remineralizing agent |
|
| Control | Other | Control is standard preventive measures (tooth brushing, fluoride tooth paste, interdental cleaning) |
|