Remineralization Effect of βTricalcium Phosphate Nanoparticles Versus FunctionalizedβTricalcium Phosphate Nanoparticles

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbiya
    • Tanta, Gharbiya, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: 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)
Experimental: 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)	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)
Experimental: sodium fluoride mouth wash; The intervention is mouth wash solution for remineralization of demineralized enamel from Oral-B company	Other: sodium fluoride mouth wash; The intervention is mouth wash solution for remineralization of demineralized enamel from Oral-B company; Other Names: Oral-B mouth wash
No Intervention: artifacial saliva; it is an artificial solution that is mimic to human saliva prepared by investigator at faculty of pharmacy Tanta university

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concentration of calcium and phosphorous in demineralized enamel	Assessment of calcium and phosphorous using Energy Dispersive X-Ray (EDX)analysis scanning electron microscope	6 weeks
enamel hardness	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.	6 weeks

Collaborators and Investigators

• Sponsor: Aya Magdy Elsadany
• Investigators: Principal Investigator: Aya MS Elsadany, PHD, Tanta University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: August 10, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: #-P-OH-8-22-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No