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NCT Number: NCT05296213

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

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

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Key information

Conditions

Enamel Caries

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kareem Hamdi

Al Mansurah, 35111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Silver diamine fluoride- potassium iodide

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

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

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

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 25, 2022
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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