Clinical trial

Evaluation of the Remineralizing Effect of Self-assembling Peptide P11-4 on Caries Affected Dentin.

Name
Nafesa Mostafa
Description
Dental caries is a biofilm-mediated, sugar-driven, multifactorial, dynamic disease that results in the phasic demineralization and remineralization of dental hard tissues. These tissues have poor regeneration capability because of the lack of both regenerative cells and vascularization. In the complex caries progression process involving dietary sugars, bacterial metabolism and demineralization, the collagenous organic matrix becomes exposed and destroyed by resident and bacterial proteases, allowing the lesion to expand
Trial arms
Trial start
2021-07-01
Estimated PCD
2021-10-01
Trial end
2021-10-30
Status
Completed
Phase
Early phase I
Treatment
Peptide
it is about synthetic protein acting on tooth structure help information apatite crystals
Arms:
Negative control group (A1), Treatment group (A2)
Other names:
peptide P11-4
Size
30
Primary endpoint
Remineralization
3 months
Eligibility criteria
Inclusion Criteria: * Patients included in the study will be required to present at least one permanent molar with an active deep carious lesion without pulpal involvement. * Age of patient: 18 -30 years * Carious lesions will be standardized by means of clinical and radiographic examinations performed before the procedures Exclusion Criteria: * Teeth with deep dentinal lesions with pulpal involvement, abscess, pain or swelling * Developmental disorders and adjacent soft tissue lesions * Patients with systemic illness will be excluded
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To study the effect of self assembling-peptide P11-4 treatment on dentine remineralization, after removal of all infected dentine (Remineralization of caries affected dentin),', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-01-06

1 organization

1 product

1 indication

Organization
Egymedicalpedia
Product
Peptide
Indication
Tooth Decay