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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

ConditionsRemineralization PotentialDentin Caries
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age20-40
SponsorAl-Azhar University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

21 Participants
are divided into 2 treatment groups
Group A: Curodont Repair Fluoride Plus (P11-4 + fluoride)Experimental treatment 2 interventions
Group B: Beautifil II LSPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Marginal integrity of restorations

Assessed using mirror and probe according to Modified USPHS Criteria

Time frame
6 months and 12 months
2

Clinical longevity of restorations

Assessed by restoration retention using mirror and probe

Time frame
6 and 12 months
3

Overall clinical performance of restorations

Evaluated using Modified USPHS Criteria

Time frame
6 and 12 months

Secondary outcomes

1

Postoperative hypersensitivity

Evaluated using cold spray test

Time frame
6 and 12 months
2

Marginal discoloration

Assessed using digital photographic method

Time frame
6 and 12 months
3

Recurrent caries

Detected using digital photographic method

Time frame
6 and 12 months
4

Surface roughness

Evaluated using digital photographic method

Time frame
6 and 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Misr University for Science and Technology

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: