NCT05296213

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

March 16, 2022

Last Update Submit

March 24, 2022

Conditions

Enamel Caries

Keywords

Enamel remineralizationRandomized Clinical TrialExperimental Tricalcium silicateSillver diamine flouride-potassium iodide

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Experimental tricalcium silicate

EXPERIMENTAL

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

Interventions

Silver diamine fluoride- potassium iodideDRUG

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

silver diamine fluoride-potassium iodide SDF-KI (riva star)
Casein phosphopeptide amorphous calcium phosphateDRUG

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

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

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

Experimental tricalcium silicate

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • smoker patients
  • pregnant females
  • patients with bad oral hygiene
  • patients with enamel defects ( Amelogenesis Imperfecta, fluorosis, cracks or any developmental defects)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kareem Hamdi

Al Mansurah, 35111, Egypt

Location

MeSH Terms

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplex

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

March 25, 2022

Study Start

December 1, 2019

Primary Completion

December 10, 2021

Study Completion

January 10, 2022

Last Updated

April 5, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available within 3 Months for 5 years
Access Criteria
for every one

Locations

EG(1)