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Teeth selected for intervention with Atraumatic Restorative Treatment will receive Glass Ionomer restorations (control) or MI varnish (test) before receiving the Glass Ionomer restoration
Patients selected to participate in the study will be randomly assigned into 2 groups.
Group 1 (test): who will receive casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP) + ART in the teeth selected, excavating only the caries infected dentine and preserving the caries affected dentine.
Group 2 (control): Who will receive ART only in the teeth selected, excavating only the caries infected dentine and preserving the caries affected dentine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test (ART + CPP-ACP) | Experimental | In this group, teeth selected will receive intervention with CPP-ACP and restorations with light cured Glass Ionomer restorations after excavating the carious lesions preserving the caries affected dentine using the ART |
|
| Control (ART) | Active Comparator | in this group, teeth selected will receive restorations with light cured Glass Ionomer restorations after excavating the carious lesions preserving the caries affected dentine using the ART |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casein phosphopeptide amorphous calcium phosphate | Drug | varnish containing calcium and phospate ions which act as a source for tooth remineralization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the reparative ability of Casein Phosphopeptide Amorphous Calcium Phosphate varnish on caries affected dentine in primary molars. | this is by evaluating the clinical and radiographic data and also by descriptive histological assessment | 12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate and compare the clinical outcome of Atraumatic Restorative Treatment with and without Casein Phosphopeptide Amorphous Calcium Phosphate varnish placed on caries affected dentine in primary molars to evaluate the restoration success or failure. | clinical criteria and ART success criteria will be assessed | 12 months |
Inclusion Criteria:
Healthy patients.
Patients with an age range of 6-8 years old for clinical evaluation.
Patients ranking definitely positive or positive on Frankl scale.
Patients having at least 1 symptomless primary molar with caries extending to the dentine (International Caries Detection and Assessment System (ICDAS II) code 4, 5 & 6).
The presence of the permanent successors when examined by periapical X-ray.
Patients who will agree to participate in the study. For the ex-vivo sample
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed A. Bayoumi, MSc | Contact | 0122273853 | mohamed.bayoumi@pua.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed A. Bayoumi, MSc | Pharos University in Alexandria | Principal Investigator |
| Azza G. Hanno, Professor | Alexandria University | Study Director |
| Karin M. Dowidar, Professor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | Egypt |
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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 |
|---|---|
| C447032 | casein phosphopeptide-amorphous calcium phosphate nanocomplex |
| D057087 | Dental Atraumatic Restorative Treatment |
| ID | Term |
|---|---|
| D003813 | Dentistry |
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|
| Atraumatic restorative treatment | Procedure | excavation of dental caries and restoring with light cured Glass Ionomer Restoration |
|
|
| Assess the radiographic success of Atraumatic Restorative Treatment with and without CPP-ACP varnish placed on caries affected dentine in primary molars by measuring the grey value radiographically using Image J software. |
radiographic success of the teeth and radiographic density measures will be assessed |
| 12 months |
| Assess histologically the quality of the formed dentine using the Polarized Light Microscope and Scanning Electron Microscope. | polarized light microscope and scanning electron microscope will be used to describe the repaired dentine and the bacterial load | throughout the 12 months |
| Alexandria University |
| Study Director |
| Samia S. Omar, Professor | Alexandria University | Study Director |