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

NCT ID: NCT05296213

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2022-01-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Enamel Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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silver diamine fluoride-potassium iodide SDF-KI (riva star)

SDF-KI was applied once as a professional application over the early enamel lesions in cervical third of the buccal surface of molar teeth.

Group Type EXPERIMENTAL

Silver diamine fluoride- potassium iodide

Intervention Type DRUG

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)

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.

Group Type EXPERIMENTAL

Casein phosphopeptide amorphous calcium phosphate

Intervention Type DRUG

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

Experimental tricalcium silicate paste was applied twice daily over the early enamel lesions in cervical third of the buccal surface of molar teeth

Group Type EXPERIMENTAL

experimental tricalcium silicate

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kareem Hamdi

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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M03060819

Identifier Type: -

Identifier Source: org_study_id

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