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

NCT07065305 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: OPDEN-103-1-S
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Remineralization Potential; Dentin Caries

Keywords

Er, Cr: YSGG Laser; Caries-Affected Dentin; Remineralization Potential; Self-Assembling Peptide P11-4 Containing Fluoride

Outcome Measures

Primary Outcomes (3)

• Marginal integrity of restorations

  Assessed using mirror and probe according to Modified USPHS Criteria

  6 months and 12 months

• Clinical longevity of restorations

  Assessed by restoration retention using mirror and probe

  6 and 12 months

• Overall clinical performance of restorations

  Evaluated using Modified USPHS Criteria

  6 and 12 months

Secondary Outcomes (5)

• Postoperative hypersensitivity

  6 and 12 months

• Marginal discoloration

  6 and 12 months

• Recurrent caries

  6 and 12 months

• Surface roughness

  6 and 12 months

• Surface luster

  6 and 12 months

Study Arms (2)

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

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

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

Interventions

Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland DRUG

Pretreatment with Curodont Repair Fluoride Plus (P11-4 + fluoride)

Beautifil II LS; Curodont Repair Fluoride Plus (P11-4 + fluoride)

Beautifil II LS DRUG

Application of Giomer restorative material following standard adhesive procedures without pretreatment.

Also known as: S-PRG (Surface Pre-Reacted Glass-ionomer) filler, Bis-GMA, TEGDMA, glass fillers , Shofu Inc., Kyoto, Japan, Giomer-based restorative composite

Beautifil II LS; Curodont Repair Fluoride Plus (P11-4 + fluoride)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Interventions

Fluorides; Bisphenol A-Glycidyl Methacrylate; triethylene glycol dimethacrylate

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Methacrylates; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Bisphenol A Compounds; Bisphenols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Composite Resins; Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: * Eligible patients will be randomly assigned to the intervention or control group using computer-generated random numbers. * Allocation concealment will be ensured using sealed opaque envelopes. * Clinical evaluators assessing outcomes will be blinded to the group allocation to reduce bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Restorative Dentistry

Model Details: * Group 1 no pretreatment will received. * Group 2 will receive Curodont Repair (P11-4 plus fluoride).

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 15, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07