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NCT Number: NCT07065305

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

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.

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Key information

Conditions

Remineralization Potential Dentin Caries

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

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

Primary outcomes

  1. Marginal integrity of restorations

    Time frame: 6 months and 12 months

    Assessed using mirror and probe according to Modified USPHS Criteria

  2. Clinical longevity of restorations

    Time frame: 6 and 12 months

    Assessed by restoration retention using mirror and probe

  3. Overall clinical performance of restorations

    Time frame: 6 and 12 months

    Evaluated using Modified USPHS Criteria

Secondary outcomes

  1. Postoperative hypersensitivity

    Time frame: 6 and 12 months

    Evaluated using cold spray test

  2. Marginal discoloration

    Time frame: 6 and 12 months

    Assessed using digital photographic method

  3. Recurrent caries

    Time frame: 6 and 12 months

    Detected using digital photographic method

  4. Surface roughness

    Time frame: 6 and 12 months

    Evaluated using digital photographic method

  5. Surface luster

    Time frame: 6 and 12 months

    Assessed using digital photographic method

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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