Dentin Caries, Remineralization Potential
Conditions
Keywords
Er, Cr: YSGG Laser, Caries-Affected Dentin, Remineralization Potential, Self-Assembling Peptide P11-4 Containing Fluoride
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?
Interventions
DRUGCurodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland
Pretreatment with Curodont Repair Fluoride Plus (P11-4 + fluoride)
DRUGBeautifil II LS
Application of Giomer restorative material following standard adhesive procedures without pretreatment.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
* 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.
Intervention model description
* Group 1 no pretreatment will received. * Group 2 will receive Curodont Repair (P11-4 plus fluoride).
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Surface roughness | 6 and 12 months | Evaluated using digital photographic method |
| Postoperative hypersensitivity | 6 and 12 months | Evaluated using cold spray test |
| Surface luster | 6 and 12 months | Assessed using digital photographic method |
| Marginal discoloration | 6 and 12 months | Assessed using digital photographic method |
| Recurrent caries | 6 and 12 months | Detected using digital photographic method |
Outcome results
None listed