Carious LesionNCT07574814
Effect of Self-assembly Peptide With or Without Laser on Remineralization of Initial Carious
A study testing ER-CR Laser and Without ER-CR Laser in people with Carious Lesion and Caries; Initial, run by Delta University for Science and Technology at 1 site in Egypt.
Trial 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. Self- assembly peptide 2. Nano-hydroxy apitite gel 3. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Carious Lesion, Caries; Initial
- What is being tested?
- ER-CR Laser and Without ER-CR Laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Mar 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
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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Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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:
- Self- assembly peptide
- Nano-hydroxy apitite gel
- CPP-ACP varnish With or without laser treatment at three times intervals, immediately after treatment (as baseline), six months and one year
Read the 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.
- Conditions
- Carious Lesion, Caries; Initial
- Being tested
- ER-CR Laser, Without ER-CR Laser
- Keywords
- carious lesions,, laser, remineralization, CPP-ACP, self assembly peptide
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Without ER-CR LaserOther
ER-Cr laser was not used before the application of reminaralizing agents
| Study group | Role | What they receive |
|---|---|---|
| With laser pre-treatment | Active comparator | the group will be treated with Er-Cr laser before application of reminralizing agents Receives: Radiation: ER-CR Laser |
| Without laser pre-tretament | Active comparator | the group will be treated with reminralizing agent without laser pre treatment Receives: Other: Without ER-CR Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start19 Mar 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Galal Elkholy, Principal investigator, Azhar University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574814
- Sponsor's protocol ID
- 1161/135
- Status last verified
- Mar 2026
- First submitted
- 26 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07574814
- Acronym / sponsor ID
- 1161/135
- Conditions
- Carious Lesion, Caries; Initial
- Keywords
- carious lesions,, laser, remineralization, CPP-ACP, self assembly peptide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Self- assembly peptide
- Nano-hydroxy apitite gel
- CPP-ACP varnish With or without laser treatment at three times intervals, immediately after treatment (as baseline), six months and one year
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With laser pre-treatment | Active comparator | Radiation: ER-CR Laserthe group will be treated with Er-Cr laser before application of reminralizing agents |
| Without laser pre-tretament | Active comparator | Other: Without ER-CR Laserthe group will be treated with reminralizing agent without laser pre treatment |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ER-CR LaserER-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. | Radiation | With laser pre-treatment |
| Without ER-CR LaserER-Cr laser was not used before the application of reminaralizing agents | Other | Without laser pre-tretament |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Galal Elkholy principal investigator
Azhar University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ER-CR Laser and Without ER-CR Laser in people with Carious Lesion and Caries; Initial, run by Delta University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative assessment of initial carious activity in numerical value using DIAGNOdent ( laser fluorescence detecting device ) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.