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Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents

Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents: 2-years Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05296213
Enrollment
45
Registered
2022-03-25
Start date
2019-12-01
Completion date
2022-01-10
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enamel Caries

Keywords

Enamel remineralization, Randomized Clinical Trial, Experimental Tricalcium silicate, Sillver diamine flouride-potassium iodide

Brief summary

Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents

Detailed description

Medical management of incipient lesions by application of remineralizing agents like fluoride therapy, amorphous calcium phosphate (ACP), and Casin phosphopeptide amorphous calcium phosphate (CPP-ACP) has proved to be effective in reversing such lesions. Fluoride was considered the gold standard remineralizing agent , However several recent researchers found that; the ideal remineralizing agents should diffuse or deliver calcium and phosphate ions into early enamel lesion. Calcium-silicate based material such as β-CaSiO3 and β-Ca2SiO4 play an important role in hard tissue regeneration, showing good bioactivity and biocompatibility and can induce bone like apetite formation in stimulated body fluids. when β-CaSiO3 and β-Ca2SiO4 come in contact with saliva it will be dissolve forming silanol group (Si-O ) on the enamel surface which can bind to Ca ions and inducing the precipitation of hydroxyapatite. In the light of this, this study was designed to compare the remineralization potential of silver diamine flouride/ potassium iodide, casin phosphopeptide amorphous calcium phosphate and experimental tricalcium silicate on early enamel lesions.

Interventions

SDF-KI (riva star, SDI.Ltd )was applied ( as a professional application) by micro brush over the early enamel lesions on the buccal surface of molar teeth

CPP-ACP (tooth mousse, GC, Matraville Sydney, Australia) was applied by using micro brush over the early enamel lesions on the buccal surface of the molar teeth twice daily. the patients were instructed to leave it for about 3minutes before rinsing

DRUGexperimental tricalcium silicate

prepared tricalcium silicate paste was applied by using micro brush over the early enamel lesions on the buccal surface of the molar teeth twice daily. the patients were instructed to leave it for about 3minutes before rinsing

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with early enamel lesions (ICDAS score 1 and 2). * Patients with normal occlusion . * Patients must have a good oral hygiene * patients free from any systemic diseases and don't receive any medication

Exclusion criteria

* smoker patients * pregnant females * patients with bad oral hygiene * patients with enamel defects ( Amelogenesis Imperfecta, fluorosis, cracks or any developmental defects)

Design outcomes

Primary

MeasureTime frameDescription
Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents2-years after the first application of the remineralizing agentsThe primary outcome was the change in laser fluorescence values that was detected by DIAGNODent Pen. The obtained values were interpreted according to the scale provided by the manufacture: * Value between (0-13) refers to sound enamel substrate * Value between (14-20) refers to early enamel caries

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026