Remineralization Effect of βTricalcium Phosphate Nanoparticles Versus FunctionalizedβTricalcium Phosphate Nanoparticles

NCT ID: NCT06561789

Last Updated: 2024-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-10

Study Completion Date

2023-07-01

Brief Summary

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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

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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.

Conditions

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White Spot Lesions[Initial Caries]on Smooth Surface of Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Functionalized Nano ᵦ tricalcium phosphate particles

Intervention Type 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

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

Group Type EXPERIMENTAL

Nano ᵦ tricalcium phosphate particles

Intervention Type 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

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

Group Type EXPERIMENTAL

sodium fluoride mouth wash

Intervention Type OTHER

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

artifacial saliva

it is an artificial solution that is mimic to human saliva prepared by investigator at faculty of pharmacy Tanta university

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Functionalized Nano ᵦ tricalcium phosphate particles

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

Intervention Type OTHER

Nano ᵦ tricalcium phosphate particles

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

Intervention Type OTHER

sodium fluoride mouth wash

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

Intervention Type OTHER

Other Intervention Names

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Oral-B mouth wash

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aya Magdy Elsadany

OTHER

Sponsor Role lead

Responsible Party

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Aya Magdy Elsadany

Assistant lecturer of oral health and prevention department at faculty of dentistry , Tanta university

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Aya MS Elsadany, PHD

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

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Tanta university

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

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Egypt

References

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Seyedlar RM, Rezvani M, Barari S, Imani M, Nodehi A, Atai M. Synthesis of plate-like beta-tricalcium phosphate nanoparticles and their efficiency in remineralization of incipient enamel caries. Prog Biomater. 2019 Dec;8(4):261-276. doi: 10.1007/s40204-019-00126-y. Epub 2019 Dec 7.

Reference Type BACKGROUND
PMID: 31813116 (View on PubMed)

Karlinsey RL, Mackey AC, Walker ER, Frederick KE. Preparation, characterization and in vitro efficacy of an acid-modified beta-TCP material for dental hard-tissue remineralization. Acta Biomater. 2010 Mar;6(3):969-78. doi: 10.1016/j.actbio.2009.08.034. Epub 2009 Aug 27.

Reference Type BACKGROUND
PMID: 19716443 (View on PubMed)

Salinovic I, Schauperl Z, Marcius M, Miletic I. The Effects of Three Remineralizing Agents on the Microhardness and Chemical Composition of Demineralized Enamel. Materials (Basel). 2021 Oct 13;14(20):6051. doi: 10.3390/ma14206051.

Reference Type BACKGROUND
PMID: 34683643 (View on PubMed)

Sindhura V, Uloopi KS, Vinay C, Chandrasekhar R. Evaluation of enamel remineralizing potential of self-assembling peptide P11-4 on artificially induced enamel lesions in vitro. J Indian Soc Pedod Prev Dent. 2018 Oct-Dec;36(4):352-356. doi: 10.4103/JISPPD.JISPPD_255_18.

Reference Type BACKGROUND
PMID: 30324924 (View on PubMed)

Rirattanapong P, Vongsavan K, Suratit R, Tanaiutchawoot N, Charoenchokdilok V, Jeansuwannagorn S, Yoddee M. Effect of various forms of calcium in dental products on human enamel microhardness in vitro. Southeast Asian J Trop Med Public Health. 2012 Jul;43(4):1053-8.

Reference Type BACKGROUND
PMID: 23077830 (View on PubMed)

Other Identifiers

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#-P-OH-8-22-10

Identifier Type: -

Identifier Source: org_study_id

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