White Spot Lesions[Initial Caries]on Smooth Surface of ToothNCT06561789
Remineralization Effect of βTricalcium Phosphate Nanoparticles Versus FunctionalizedβTricalcium Phosphate Nanoparticles
A study testing Functionalized Nano ᵦ tricalcium phosphate particles, Nano ᵦ tricalcium phosphate particles and sodium fluoride mouth wash in people with White Spot Lesions[Initial Caries]on Smooth Surface of Tooth, run by Aya Magdy Elsadany at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions[Initial Caries]on Smooth Surface of Tooth
- What is being tested?
- Functionalized Nano ᵦ tricalcium phosphate particles, Nano ᵦ tricalcium phosphate particles and sodium fluoride mouth wash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2023to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The selected teeth were free from caries, hypocalcification restoration, fracture fluorosis and cracks
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Functionalized Nano ᵦ tricalcium phosphate particles, Nano ᵦ tricalcium phosphate particles, sodium fluoride mouth wash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functionalized Nano ᵦ tricalcium phosphate particlesOther
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 particlesOther
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 washOther
Also called Oral-B mouth wash
The intervention is mouth wash solution for remineralization of demineralized enamel from Oral-B company
| Study group | Role | What they receive |
|---|---|---|
| Functionalized Nano ᵦ tricalcium phosphate particles | Experimental | The intervention is a prepared mouth wash solution for remineralization of demineralized enamel by investigator at Nano Gate institute (Egypt,cairo,elmokatm) Receives: Other: Functionalized Nano ᵦ tricalcium phosphate particles |
| Nano ᵦ tricalcium phosphate particles | Experimental | The intervention is a prepared mouth wash solution for remineralization of demineralized enamel by investigator at Nano Gate institute(Egypt,cairo,elmokatm) Receives: Other: Nano ᵦ tricalcium phosphate particles |
| sodium fluoride mouth wash | Experimental | The intervention is mouth wash solution for remineralization of demineralized enamel from Oral-B company Receives: Other: sodium fluoride mouth wash |
| artifacial saliva | No intervention | it is an artificial solution that is mimic to human saliva prepared by investigator at faculty of pharmacy Tanta university |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of calcium and phosphorous in demineralized enamel
Assessment of calcium and phosphorous using Energy Dispersive X-Ray (EDX)analysis scanning electron microscope
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start10 Mar 2023
- Primary completion10 May 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for White Spot Lesions[Initial Caries]on Smooth Surface of ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aya Magdy Elsadany
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Magdy Elsadany, Tanta University
- Investigators
- Aya MS Elsadany, PHD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561789
- Sponsor's protocol ID
- #-P-OH-8-22-10
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31813116Karlinsey 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.
PubMed 19716443Salinovic 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.
PubMed 34683643Sindhura 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.
PubMed 30324924Rirattanapong 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.
PubMed 23077830
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Remineralizing Potential of β-Tricalcium Phosphate Nanoparticles Versus Functionalizedβ-Tricalcium Phosphate Nanoparticles
- ClinicalTrials.gov ID
- NCT06561789
- Acronym / sponsor ID
- #-P-OH-8-22-10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aya Magdy ElsadanyUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Functionalized Nano ᵦ tricalcium phosphate particles | Experimental | Other: Functionalized Nano ᵦ tricalcium phosphate particlesThe 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 | Experimental | Other: Nano ᵦ tricalcium phosphate particlesThe intervention is a prepared mouth wash solution for remineralization of demineralized enamel by investigator at Nano Gate institute(Egypt,cairo,elmokatm) |
| sodium fluoride mouth wash | Experimental | Other: sodium fluoride mouth washThe intervention is mouth wash solution for remineralization of demineralized enamel from Oral-B company |
| artifacial saliva | No intervention | –it is an artificial solution that is mimic to human saliva prepared by investigator at faculty of pharmacy Tanta university |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The selected teeth were free from caries, hypocalcification restoration, fracture fluorosis and cracks
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functionalized Nano ᵦ tricalcium phosphate particlesThe intervention is a prepared mouth wash solution for remineralization of demineralized enamel by the investigator at Nano Gate institute (Egypt,cairo,elmokatm) | Other | Functionalized Nano ᵦ tricalcium phosphate particles |
| Nano ᵦ tricalcium phosphate particlesThe intervention is a prepared mouth wash solution for remineralization of demineralized enamel by the investigator at Nano Gate institute (Egypt,cairo,elmokatm) | Other | Nano ᵦ tricalcium phosphate particles |
| sodium fluoride mouth washAlso: Oral-B mouth washThe intervention is mouth wash solution for remineralization of demineralized enamel from Oral-B company | Other | sodium fluoride mouth wash |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 31813116Seyedlar 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.
- Background: PubMed 19716443Karlinsey 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.
- Background: PubMed 34683643Salinovic 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.
- Background: PubMed 30324924Sindhura 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.
- Background: PubMed 23077830Rirattanapong 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aya MS Elsadany, PHD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functionalized Nano ᵦ tricalcium phosphate particles, Nano ᵦ tricalcium phosphate particles and sodium fluoride mouth wash in people with White Spot Lesions[Initial Caries]on Smooth Surface of Tooth, run by Aya Magdy Elsadany at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of calcium and phosphorous in demineralized enamel (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561789, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.