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

M

Mansoura University

Status

Completed

Conditions

Enamel Caries

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05296213
M03060819

Details and patient eligibility

About

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

Full 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.

Enrollment

45 patients

Sex

All

Ages

15 to 50 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

45 participants in 3 patient groups

silver diamine fluoride-potassium iodide SDF-KI (riva star)
Experimental group
Description:
SDF-KI was applied once as a professional application over the early enamel lesions in cervical third of the buccal surface of molar teeth.
Treatment:
Drug: Silver diamine fluoride- potassium iodide
casein phosphopeptide amorphous calcium phosphate CPP-ACP(tooth mousse)
Experimental group
Description:
CPP-ACP cream was applied twice daily according to manufacturer's instructions over the early enamel lesions in cervical third of the buccal surface of molar teeth.
Treatment:
Drug: Casein phosphopeptide amorphous calcium phosphate
Experimental tricalcium silicate
Experimental group
Description:
Experimental tricalcium silicate paste was applied twice daily over the early enamel lesions in cervical third of the buccal surface of molar teeth
Treatment:
Drug: experimental tricalcium silicate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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