Clinical trial
Clinical Evaluation of Biomimetic Self -Assembling Peptide (p11-4) in The Remineralization of Early Enamel Caries in Permanent Teeth
Name
self assembling peptides
Description
Evaluate clinically the remineralizing potential of self-assembling peptide ( P11-4) fluoride plus in early enamel carious lesions of permanent anterior teeth.
Trial arms
Trial start
2024-06-06
Estimated PCD
2024-11-06
Trial end
2025-01-06
Status
Not yet recruiting
Phase
Early phase I
Treatment
self assembling peptide p11-4 with fluoride
Self-assembling peptide (P11-4) fluoride plus will be applied according to the manufacturer's instructions by pushing the two cylinders together and will left for 5 min till the tooth surface appears dry to insure its diffusion
The remineralizing process of the early enamel carious lesions will be assessed quantitatively using the laser fluorescence DIAGNOdent measuring and assessed qualitatively using ICDAS II scoring system at baseline 1, 3, 6 months post-treatment
Arms:
curodont repair fluoride plus
Other names:
curodont repair fluoride plus varnish
5% sodium fluoride varnish
Fluoride varnish will be applied under manufacturer instructions by applying thin layer of varnish with a brush in strokes The remineralizing process of the early enamel carious lesions will be assessed quantitatively using the laser fluorescence DIAGNOdent measuring and assessed qualitatively using ICDAS II scoring system at baseline 1, 3, 6 months post-treatment
Arms:
fluoride varnish
Other names:
charm fluoride varnish
Size
50
Primary endpoint
Remineralization potential
1 month
Eligibility criteria
Inclusion Criteria:
* Presence of active non-cavitated carious white spot lesions with DIAGNO/dent reading from 5 to 17 ,on labial surfaces of permanent anterior teeth and International Caries Detection And Assessment System II (ICDAS II) ranging between 1 and 3.
* The children' age range between 10 to14 years old.
* Children had completed fixed orthodontic treatment within the past week.
* Good oral hygiene with a plaque index score 0 or 1.
* No systemic diseases or medication affecting salivary flow.
Exclusion Criteria:
* Children with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia.
* Children had fluoride application less than 3 months before the study.
* Presence of restoration and cavitation on the surface to be treated.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-05-23
1 organization
Organization
Tanta University