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Completed

NCT Number: NCT06561789

Remineralization Effect of βTricalcium Phosphate Nanoparticles Versus FunctionalizedβTricalcium Phosphate Nanoparticles

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta university

Tanta, Gharbia Governorate, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Functionalized Nano ᵦ tricalcium phosphate particles

Other

The intervention is a prepared mouth wash solution for remineralization of demineralized enamel by the investigator at Nano Gate institute (Egypt,cairo,elmokatm)

Nano ᵦ tricalcium phosphate particles

Other

The intervention is a prepared mouth wash solution for remineralization of demineralized enamel by the investigator at Nano Gate institute (Egypt,cairo,elmokatm)

sodium fluoride mouth wash

Other

The intervention is mouth wash solution for remineralization of demineralized enamel from Oral-B company

Other names: Oral-B mouth wash

Primary outcomes

  1. concentration of calcium and phosphorous in demineralized enamel

    Time frame: 6 weeks

    Assessment of calcium and phosphorous using Energy Dispersive X-Ray (EDX)analysis scanning electron microscope

  2. enamel hardness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aya Magdy Elsadany

Other

Registry information

Official study title

Efficacy of Remineralizing Potential of β-Tricalcium Phosphate Nanoparticles Versus Functionalizedβ-Tricalcium Phosphate Nanoparticles

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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