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

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

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

Study Overview

• Status: Completed
• Conditions: Enamel Caries
• Intervention / Treatment: Drug: Silver diamine fluoride- potassium iodide; Drug: Casein phosphopeptide amorphous calcium phosphate; Drug: experimental tricalcium silicate

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35111
    • Kareem Hamdi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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
EXPERIMENTAL: 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.	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
EXPERIMENTAL: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ACTUAL): December 10, 2021
• Study Completion (ACTUAL): January 10, 2022

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (ACTUAL): March 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Randomized Clinical Trial; Enamel remineralization; Experimental Tricalcium silicate; Sillver diamine flouride-potassium iodide
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Calcium-Regulating Hormones and Agents; Cariostatic Agents; Chelating Agents; Sequestering Agents; Calcium; Fluorides; Caseins
• Other Study ID Numbers: M03060819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will be available within 3 Months for 5 years
• IPD Sharing Access Criteria: for every one
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No