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

Not Applicable

Completed

• Conditions: Enamel Caries
• Interventions: Drug: Casein phosphopeptide amorphous calcium phosphate; Drug: experimental tricalcium silicate; Drug: Silver diamine fluoride- potassium iodide

• Registration Number: NCT05296213
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2021-12-10
• Study Completion: 2022-01-10
• Status Verified: 2022-03
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-16
• Last Update Submitted: 2022-03-24
• Study First Posted: 2022-03-25
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents	2-years after the first application of the remineralizing 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

Trial Locations

Locations (1)

Kareem Hamdi; 🇪🇬 Mansoura, Egypt