Remineralization PotentialEarly Phase 1NCT07065305
Clinical Performance and Remineralization Potential of Self- Assembling Peptide P11-4 Containing Fluoride Versus Er, Cr: YSGG Laser Treatment and Micro Tensile Bond Strength of Giomer Restoration in Carious Lesions
A Early Phase 1 study testing Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland and Beautifil II LS in people with Remineralization Potential and Dentin Caries, run by Al-Azhar University.
Trial summary
This study will be performed in two parts, in vivo and in vitro to assess the effect of the remineralization potential of self-assembling peptide P11-4 containing Fluoride on caries-affected dentin compared to untreated caries-affected dentin and the influence of Er, Cr: YSGG Laser treatment. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Remineralization Potential, Dentin Caries
- What is being tested?
- Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland and Beautifil II LS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 15 Sep 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- o Patients aged (20 - 40) years.
- Presence of at least one posterior permanent molar with an occlusal carious lesion classified as ICDAS code 3 or 4 requiring operative treatment.
- Good general and oral health.
- Willingness to participate and provide informed consent.
Who cannot join
- o Patients with systemic conditions affecting oral health or healing.
- Teeth with pulp involvement or periapical pathology.
- Allergy to study materials.
- Poor oral hygiene or periodontal disease in the target tooth region.
About this study
This study will be performed in two parts, in vivo and in vitro to assess the effect of the remineralization potential of self-assembling peptide P11-4 containing Fluoride on caries-affected dentin compared to untreated caries-affected dentin and the influence of Er, Cr: YSGG Laser treatment.
Read the detailed description
The present study will be performed to evaluate the remineralization potential of the self-assembling peptide P11-4 combined with fluoride treatment applied over demineralized dentin in occlusal carious molars.
- Research objectives: To assess the effect of the two treatment modalities to enhance remineralization of demineralized dentin and clinical performance of restorations.
- Research question: Will pretreatment of caries affected dentin using self-assembling peptide P11-4 containing fluoride compared to untreated caries-affected dentin will enhance the remineralization and clinical performance of composite restorations In Vitro Study 1- The present study will be performed to evaluate the remineralization potential of the self-assembling peptide P11-4 combined with fluoride and its effect on bond strength and analyze morphological changes over demineralized dentin in occlusal carious molars using Scanning Electron Microscopy (SEM).
- Research Objectives: To evaluate the effect of Curodont Repair Fluoride Plus and Er,Cr:YSGG laser pretreatment on the bond strength of composite resin to superficial and deep dentin.
- Research question: Will pretreatment of caries affected dentin using self-assembling peptide P11-4 containing fluoride compared to untreated caries-affected dentin will enhance bond strength?
- Conditions
- Remineralization Potential, Dentin Caries
- Being tested
- Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland, Beautifil II LS
- Keywords
- Er, Cr: YSGG Laser, Caries-Affected Dentin, Remineralization Potential, Self-Assembling Peptide P11-4 Containing Fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, SwitzerlandDrug
Pretreatment with Curodont Repair Fluoride Plus (P11-4 + fluoride)
Beautifil II LSDrug
Also called S-PRG (Surface Pre-Reacted Glass-ionomer) filler, Bis-GMA, TEGDMA, glass fillers , Shofu Inc., Kyoto, Japan, Giomer-based restorative composite
Application of Giomer restorative material following standard adhesive procedures without pretreatment.
| Study group | Role | What they receive |
|---|---|---|
| Curodont Repair Fluoride Plus (P11-4 + fluoride) | Experimental | • In the Intervention group the Curodont Repair (P11-4 + fluoride) will be applied according to the manufacturer's instructions: The paste is gently applied to the dentin surface and left undisturbed for 5 minutes to allow self-assembly and infiltration and excess material will be removed with a gentle air spray Receives: Drug: Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland; Drug: Beautifil II LS |
| Beautifil II LS | Placebo comparator | No pretreatment; proceed directly to bonding. Then the surface will dry with absorbent paper. A layer of the adhesive system (BeautiBond extrem, Shofu Inc., Kyoto, Japan) will be actively applied for 20 seconds using a micro brush. Then, the adhesive will light-cure for 10 seconds with Radii-cal LED light curing device (1200 mW/cm2) (SDI, Bayswater, Australia) (2 Receives: Drug: Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland; Drug: Beautifil II LS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal integrity of restorations
Assessed using mirror and probe according to Modified USPHS Criteria
Measured: 6 months and 12 months
Clinical longevity of restorations
Assessed by restoration retention using mirror and probe
Measured: 6 and 12 months
Overall clinical performance of restorations
Evaluated using Modified USPHS Criteria
Measured: 6 and 12 months
Secondary outcomes (5)
Postoperative hypersensitivity
Evaluated using cold spray test
Measured: 6 and 12 months
Marginal discoloration
Assessed using digital photographic method
Measured: 6 and 12 months
Recurrent caries
Detected using digital photographic method
Measured: 6 and 12 months
Surface roughness
Evaluated using digital photographic method
Measured: 6 and 12 months
Surface luster
Assessed using digital photographic method
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remineralization PotentialStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group 1 no pretreatment will received. * Group 2 will receive Curodont Repair (P11-4 plus fluoride).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatheya Mansour Elshinawy, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065305
- Sponsor's protocol ID
- OPDEN-103-1-S
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Remineralization Potential of Self- Assembling Peptide P11-4 Containing Fluoride Versus Er, Cr: YSGG Laser Treatment and Micro Tensile Bond Strength of Giomer Restoration in Carious Lesions
- ClinicalTrials.gov ID
- NCT07065305
- Acronym / sponsor ID
- OPDEN-103-1-S
- Conditions
- Remineralization Potential, Dentin Caries
- Keywords
- Er, Cr: YSGG Laser, Caries-Affected Dentin, Remineralization Potential, Self-Assembling Peptide P11-4 Containing Fluoride
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 15 Jul 2025 (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 will be performed in two parts, in vivo and in vitro to assess the effect of the remineralization potential of self-assembling peptide P11-4 containing Fluoride on caries-affected dentin compared to untreated caries-affected dentin and the influence of Er, Cr: YSGG Laser treatment.
Detailed description
The present study will be performed to evaluate the remineralization potential of the self-assembling peptide P11-4 combined with fluoride treatment applied over demineralized dentin in occlusal carious molars.
- Research objectives: To assess the effect of the two treatment modalities to enhance remineralization of demineralized dentin and clinical performance of restorations.
- Research question: Will pretreatment of caries affected dentin using self-assembling peptide P11-4 containing fluoride compared to untreated caries-affected dentin will enhance the remineralization and clinical performance of composite restorations In Vitro Study 1- The present study will be performed to evaluate the remineralization potential of the self-assembling peptide P11-4 combined with fluoride and its effect on bond strength and analyze morphological changes over demineralized dentin in occlusal carious molars using Scanning Electron Microscopy (SEM).
- Research Objectives: To evaluate the effect of Curodont Repair Fluoride Plus and Er,Cr:YSGG laser pretreatment on the bond strength of composite resin to superficial and deep dentin.
- Research question: Will pretreatment of caries affected dentin using self-assembling peptide P11-4 containing fluoride compared to untreated caries-affected dentin will enhance bond strength?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- * Group 1 no pretreatment will received. * Group 2 will receive Curodont Repair (P11-4 plus fluoride).
| Arm | Type | Receives |
|---|---|---|
| Curodont Repair Fluoride Plus (P11-4 + fluoride) | Experimental | Drug: Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland, Drug: Beautifil II LS• In the Intervention group the Curodont Repair (P11-4 + fluoride) will be applied according to the manufacturer's instructions: The paste is gently applied to the dentin surface and left undisturbed for 5 minutes to allow self-assembly and infiltration and excess material will be removed with a gentle air spray |
| Beautifil II LS | Placebo comparator | Drug: Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland, Drug: Beautifil II LSNo pretreatment; proceed directly to bonding. Then the surface will dry with absorbent paper. A layer of the adhesive system (BeautiBond extrem, Shofu Inc., Kyoto, Japan) will be actively applied for 20 seconds using a micro brush. Then, the adhesive will light-cure for 10 seconds with Radii-cal LED light curing device (1200 mW/cm2) (SDI, Bayswater, Australia) (2 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- o Patients aged (20 - 40) years.
Key exclusion criteria (4 listed)
- o Patients with systemic conditions affecting oral health or healing.
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 |
|---|---|---|
| Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, SwitzerlandPretreatment with Curodont Repair Fluoride Plus (P11-4 + fluoride) | Drug | Beautifil II LS, Curodont Repair Fluoride Plus (P11-4 + fluoride) |
| Beautifil II LSAlso: S-PRG (Surface Pre-Reacted Glass-ionomer) filler, Bis-GMA, TEGDMA, glass fillers , Shofu Inc., Kyoto, Japan, Giomer-based restorative compositeApplication of Giomer restorative material following standard adhesive procedures without pretreatment. | Drug | Beautifil II LS, Curodont Repair Fluoride Plus (P11-4 + fluoride) |
Primary outcome
Marginal integrity of restorations
Time frame: 6 months and 12 months
Assessed using mirror and probe according to Modified USPHS Criteria
Clinical longevity of restorations
Time frame: 6 and 12 months
Assessed by restoration retention using mirror and probe
Overall clinical performance of restorations
Time frame: 6 and 12 months
Evaluated using Modified USPHS Criteria
5 secondary outcomes
Postoperative hypersensitivity
Time frame: 6 and 12 months
Marginal discoloration
Time frame: 6 and 12 months
Recurrent caries
Time frame: 6 and 12 months
Surface roughness
Time frame: 6 and 12 months
Surface luster
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland and Beautifil II LS in people with Remineralization Potential and Dentin Caries, run by Al-Azhar University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Marginal integrity of restorations (time frame: 6 months and 12 months). The study lists 3 primary outcomes in all. 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 29 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.