NCT07574814

Brief Summary

This study aimed to asses the effect of different remineralizing agents on the initial carious lesions at diff rant after immediately after treatment (as baseline), six months and one year. Objectives: Evaluation of reminralizing effect of:

  1. 1.Self- assembly peptide
  2. 2.Nano-hydroxy apitite gel
  3. 3.CPP-ACP varnish With or without laser treatment at three times intervals, immediately after treatment (as baseline), six months and one year

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

April 26, 2026

Last Update Submit

May 3, 2026

Conditions

Carious LesionCaries; Initial

Keywords

carious lesions,laserremineralizationCPP-ACPself assembly peptide

Outcome Measures

Primary Outcomes (1)

  • Quantitative assessment of initial carious activity in numerical value using DIAGNOdent ( laser fluorescence detecting device )

    Assessment of initial carious activity after using three different reminralizing agents with \\ without laser pre treatment using DIAGNOdent laser fluorescence detecting device

    1 year

Study Arms (2)

With laser pre-treatment

ACTIVE COMPARATOR

the group will be treated with Er-Cr laser before application of reminralizing agents

Radiation: ER-CR Laser

Without laser pre-tretament

ACTIVE COMPARATOR

the group will be treated with reminralizing agent without laser pre treatment

Other: Without ER-CR Laser

Interventions

ER-CR LaserRADIATION

ER-CR laser was applied for 10 sec in non-contact mode, at a distance of two mm, with pulse duration of 60 microsecond at four-Watt energy (80% water 60% air), 50 Hz energy.

With laser pre-treatment
Without ER-CR LaserOTHER

ER-Cr laser was not used before the application of reminaralizing agents

Without laser pre-tretament

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Galal Elkholy

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Mohamed Galal Elkholy

    Azhar University, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2026

First Posted

May 8, 2026

Study Start

March 19, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

May 8, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)