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

Primary Purpose

Enamel Caries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Silver diamine fluoride- potassium iodide
Casein phosphopeptide amorphous calcium phosphate
experimental tricalcium silicate
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enamel Caries focused on measuring Enamel remineralization, Randomized Clinical Trial, Experimental Tricalcium silicate, Sillver diamine flouride-potassium iodide

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Kareem Hamdi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

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

casein phosphopeptide amorphous calcium phosphate CPP-ACP(tooth mousse)

Experimental tricalcium silicate

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 16, 2022
Last Updated
March 24, 2022
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05296213
Brief Title
Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents
Official Title
Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents: 2-years Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enamel Caries
Keywords
Enamel remineralization, Randomized Clinical Trial, Experimental Tricalcium silicate, Sillver diamine flouride-potassium iodide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
silver diamine fluoride-potassium iodide SDF-KI (riva star)
Arm Type
Experimental
Arm Description
SDF-KI was applied once as a professional application over the early enamel lesions in cervical third of the buccal surface of molar teeth.
Arm Title
casein phosphopeptide amorphous calcium phosphate CPP-ACP(tooth mousse)
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental tricalcium silicate
Arm Type
Experimental
Arm Description
Experimental tricalcium silicate paste was applied twice daily over the early enamel lesions in cervical third of the buccal surface of molar teeth
Intervention Type
Drug
Intervention Name(s)
Silver diamine fluoride- potassium iodide
Intervention Description
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
Intervention Name(s)
Casein phosphopeptide amorphous calcium phosphate
Intervention Description
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
Intervention Name(s)
experimental tricalcium silicate
Intervention Description
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 Outcome Measure Information:
Title
Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents
Description
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
Time Frame
2-years after the first application of the remineralizing agents

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Kareem Hamdi
City
Mansoura
ZIP/Postal Code
35111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Data will be available within 3 Months for 5 years
IPD Sharing Access Criteria
for every one

Learn more about this trial

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

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