Remineralization Effect of βTricalcium Phosphate Nanoparticles Versus FunctionalizedβTricalcium Phosphate Nanoparticles

Not Applicable

Completed

• Conditions: White Spot Lesions[Initial Caries]on Smooth Surface of Tooth
• Interventions: Other: sodium fluoride mouth wash; Other: Functionalized Nano ᵦ tricalcium phosphate particles; Other: Nano ᵦ tricalcium phosphate particles

• Registration Number: NCT06561789
• Lead Sponsor: Aya Magdy Elsadany

Brief Summary

The study collects Sixty non carious sound human permanent premolars from Tanta University's maxillofacial surgery department. The teeth are cleaned and prepared, and randomly assigned into four groups. The specimens are analyzed using an EDX analysis scanning electron microscope, and surface micro-hardness is determined using a Digital Display Vickers Micro-hardness Tester.

Detailed Description

The study involves collecting Sixty non carious sound human permanent premolars from an outpatient clinic at Tanta University's maxillofacial surgery department. The teeth are selected for their absence of caries, hypocalcification restoration, fracture fluorosis, and cracks. The teeth are cleaned and prepared for the study, including demineralization and artificial incipient enamel carious lesion preparation. The teeth are randomly assigned into four groups: functionalized Nano ᵦ tricalcium phosphate particles, Nano ᵦ tricalcium phosphate particles, sodium fluoride mouth wash, and artificial saliva. The pH of all groups is adjusted at 7. The specimens are treated in a daily pH cycling regime, with daily solution replacements. The specimens are then dried and analyzed using an Energy Dispersive X-Ray (EDX) analysis scanning electron microscope. The element content distribution of calcium and phosphorus elements is measured, and the specimens are evaluated at base line, after demineralization, and after 2, 4, and 6 weeks. Surface micro-hardness is determined using a Digital Display Vickers Micro-hardness Tester.

Data will be collected, presented, and statistically analyzed using SPSS software package system using ANOVA at a significance level of 0.05.

Study Timeline

• Study Start: 2023-03-10
• Primary Completion: 2023-05-10
• Study Completion: 2023-07-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-10
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The selected teeth were free from caries, hypocalcification restoration, fracture fluorosis and cracks

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sodium fluoride mouth wash	sodium fluoride mouth wash	The intervention is mouth wash solution for remineralization of demineralized enamel from Oral-B company
Functionalized Nano ᵦ tricalcium phosphate particles	Functionalized Nano ᵦ tricalcium phosphate particles	The intervention is a prepared mouth wash solution for remineralization of demineralized enamel by investigator at Nano Gate institute (Egypt,cairo,elmokatm)
Nano ᵦ tricalcium phosphate particles	Nano ᵦ tricalcium phosphate particles	The intervention is a prepared mouth wash solution for remineralization of demineralized enamel by investigator at Nano Gate institute(Egypt,cairo,elmokatm)

Primary Outcome Measures

Name	Time	Method
enamel hardness	6 weeks	Surface Micro-hardness will be determined using Digital Display Vickers Micro-hardness Tester\* with a Vickers diamond indenter and a 20X objective lens. A load of 100g will be applied to the surface of the specimens for 20 seconds.
concentration of calcium and phosphorous in demineralized enamel	6 weeks	Assessment of calcium and phosphorous using Energy Dispersive X-Ray (EDX)analysis scanning electron microscope

Trial Locations

Locations (1)

Tanta university; 🇪🇬 Tanta, Gharbiya, Egypt