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
- Conditions
- Remineralization PotentialDentin Caries
- Interventions
- Drug: Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, SwitzerlandDrug: Beautifil II LS
- Registration Number
- NCT07065305
- Lead Sponsor
- Al-Azhar University
- 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.
- Detailed 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?
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 21
-
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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Curodont Repair Fluoride Plus (P11-4 + fluoride) Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland • 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 (P11-4 + fluoride) Beautifil II LS • 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 Beautifil II LS Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland 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 Beautifil II LS 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
- Primary Outcome Measures
Name Time Method Marginal integrity of restorations 6 months and 12 months Assessed using mirror and probe according to Modified USPHS Criteria
Clinical longevity of restorations 6 and 12 months Assessed by restoration retention using mirror and probe
Overall clinical performance of restorations 6 and 12 months Evaluated using Modified USPHS Criteria
- Secondary Outcome Measures
Name Time Method Postoperative hypersensitivity 6 and 12 months Evaluated using cold spray test
Marginal discoloration 6 and 12 months Assessed using digital photographic method
Recurrent caries 6 and 12 months Detected using digital photographic method
Surface roughness 6 and 12 months Evaluated using digital photographic method
Surface luster 6 and 12 months Assessed using digital photographic method