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

Enamel Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296213
• Other study ID #: M03060819
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Dental Caries
• Enamel Caries

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