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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05296213
Other study ID # M03060819
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date January 10, 2022

Study information

Verified date March 2022
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 10, 2022
Est. primary completion date December 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 50 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Silver diamine fluoride- potassium iodide
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
Casein phosphopeptide amorphous calcium phosphate
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
experimental 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

Locations

Country Name City State
Egypt Kareem Hamdi Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents The 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
2-years after the first application of the remineralizing agents
See also
  Status Clinical Trial Phase
Completed NCT04155658 - Evaluation of Efficacy of Sodium Monofluorophosphate (SMPF) Toothpastes on Enamel Lesion Remineralisation N/A
Completed NCT04685889 - Resin Infiltration Treatment for MIH N/A
Not yet recruiting NCT06425536 - Efficacy of Remineralizing Products Used in Molar Grooves: Evaluation With Diagnodent Pen and Diagnocam N/A
Completed NCT04756557 - Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults N/A
Not yet recruiting NCT03774498 - Effect of Different Over-the-counter Toothpastes on Enamel Remineralization N/A