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

Al-Azhar University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Dentin Caries; Remineralization Potential

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07065305

OPDEN-103-1-S

Details and patient eligibility

About

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.

Full 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?

Enrollment: 21 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups, including a placebo group

Curodont Repair Fluoride Plus (P11-4 + fluoride)

Experimental group

Description:

• 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

Treatment:

Drug: Beautifil II LS

Drug: 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

Placebo Comparator group

Description:

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

Treatment:

Drug: Beautifil II LS

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