Clinical trial NCT06561789: Remineralization Effect of βTricalcium Phosphate Nanoparticles Versus FunctionalizedβTricalcium Phosphate Nanoparticles
Official title: Efficacy of Remineralizing Potential of β-Tricalcium Phosphate Nanoparticles Versus Functionalizedβ-Tricalcium Phosphate Nanoparticles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesions[Initial Caries]on Smooth Surface of Tooth
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: concentration of calcium and phosphorous in demineralized enamel
timeFrame: 6 weeks
measure: enamel hardness
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
state: Gharbiya
Study officials:
affiliation: Tanta University
name: Aya MS Elsadany, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.