Effect of Self-assembly Peptide With or Without Laser on Remineralization of Initial Carious

May 3, 2026 updated by: Delta University for Science and Technology

Effect of Self-assembly Peptide With or Without Laser Treatment on the Remineralization of Initial Carious Lesion. Randomized Controlled Clinical Trials. (An In-vivo Study)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aimed to asses the effect of different remineralizing agents ( self-assembly peptide, nanohydroxy apitite gel and CPP-ACP varnish) with or without laser surface treatment on the initial carious lesions after immediately after treatment (as baseline), six months and one year using detecting device.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Mohamed Galal Elkholy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: between 18 and 35 years of age, active carious (ICDAS), had received conventional manual periodontal therapy, had no systemic diseases or concomitant medication affecting salivary flow.

-

Exclusion Criteria:Participant in another trial, non-carious lesion (enamel hypoplasia and dental fluorosis), Presence of abnormal oral, medical, or mental condition. Participants who had evidence of reduced salivary flow or significant tooth wear, also who had allergy to MI paste.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: With laser pre-treatment
the group will be treated with Er-Cr laser before application of reminralizing agents
Radiation: ER-CR Laser
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.
Active Comparator: Without laser pre-tretament
the group will be treated with reminralizing agent without laser pre treatment
Other: Without ER-CR Laser
ER-Cr laser was not used before the application of reminaralizing agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative assessment of initial carious activity in numerical value using DIAGNOdent ( laser fluorescence detecting device )
Time Frame: 1 year
Assessment of initial carious activity after using three different reminralizing agents with \ without laser pre treatment using DIAGNOdent laser fluorescence detecting device
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Delta University for Science and Technology

Investigators

  • Principal Investigator: Mohamed Galal Elkholy, Azhar University, Cairo, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2025

Primary Completion (Actual)

April 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

April 26, 2026

First Submitted That Met QC Criteria

May 3, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1161/135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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