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
NCT ID: NCT07065305
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
21 participants
INTERVENTIONAL
2025-09-15
2026-09-15
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
* Group 2 will receive Curodont Repair (P11-4 plus fluoride).
TREATMENT
SINGLE
* Allocation concealment will be ensured using sealed opaque envelopes.
* Clinical evaluators assessing outcomes will be blinded to the group allocation to reduce bias.
Study Groups
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Curodont Repair Fluoride Plus (P11-4 + fluoride)
• 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
Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland
Pretreatment with Curodont Repair Fluoride Plus (P11-4 + fluoride)
Beautifil II LS
Application of Giomer restorative material following standard adhesive procedures without pretreatment.
Beautifil II LS
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
Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland
Pretreatment with Curodont Repair Fluoride Plus (P11-4 + fluoride)
Beautifil II LS
Application of Giomer restorative material following standard adhesive procedures without pretreatment.
Interventions
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Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland
Pretreatment with Curodont Repair Fluoride Plus (P11-4 + fluoride)
Beautifil II LS
Application of Giomer restorative material following standard adhesive procedures without pretreatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Teeth with pulp involvement or periapical pathology.
* Allergy to study materials.
* Poor oral hygiene or periodontal disease in the target tooth region.
20 Years
40 Years
ALL
Yes
Sponsors
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Al-Azhar University
OTHER
Responsible Party
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Fatheya Mansour Elshinawy
Assistant lecturer of Restorative Dentistry
Other Identifiers
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OPDEN-103-1-S
Identifier Type: -
Identifier Source: org_study_id
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