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Clinical trial

The Effect of Poly Amido Amine Dendrimer, Nano-hydroxyapatite and Their Combination on Micro Hardness of Demineralized Enamel and Their Clinical Efficacy in Management of White Spot Lesions

ID
Name
Asmaa Khater
Description
Dental caries is a common oral disease. The process of caries formation is a cycle of remineralization and demineralization with various stages being either reversible or irreversible.
Trial arms
Trial start
2022-06-01
Estimated PCD
2022-12-01
Trial end
2022-12-15
Status
Completed
Phase
Early phase I
Treatment
Poly(Amidoamine) dendrimer
to evaluate the Remineralizing effect of Poly Amido Amine Dendrimer, Nanohydroxy apatite \& Their Combination on demineralized enamel \& Their Clinical Efficacy on White Spot lesion
Arms:
patients have White spot lesions
Other names:
Nano-hydroxyapatite
Size
45
Primary endpoint
Remineralization
3 months
Eligibility criteria
Inclusion Criteria: * The patients have at least 3 WSLS. * The patients aged between 16 and 25 years old * The patients with good general health and no systemic disease. Exclusion Criteria: * Presence of enamel hypoplasia or dental fluorosis. * Presence of carious cavity. * Allergy to fluoride gel being used in this stufy * Patients who have a significant medical history, including pregnancy and breast feeding and smokers. * Patients who have evidence of reduced salivary flow or significant tooth wear. * Patients who had participating in concurrent clinical trials or who had recently participated in other clinical trials of an investigational drug or device.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}
Updated at
2023-03-16

1 organization

1 product

1 indication

Organization
Egymedicalpedia
Product
Poly(Amidoamine) dendrimer
Indication
Dental Caries