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Completed

NCT Number: NCT07574814

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

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

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Key information

Conditions

Carious Lesion Caries; Initial Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Galal Elkholy

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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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.

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Treatment and study plan

ER-CR Laser

Radiation

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.

Without ER-CR Laser

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Delta University for Science and Technology

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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