Caries; Initial
Conditions
Brief summary
Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.
Detailed description
This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate remineralization potential of P11-4 combined with fluoride compared to fluoride varnish in management of incipient white spot carious lesions. Progress of the lesions will be assessed using laser fluorescence (DIAGNOdent).
Interventions
OTHERBifluorid 10 fluoride varnish
5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride)
COMBINATION_PRODUCTCurodont Repair Fluoride Plus
P11-4 self assembling peptide combined with fluoride
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Active carious white spot lesions. * Patient compliance. * Controlled oral hygiene condition.
Exclusion criteria
* Participant in another trial. * Non carious lesions. * Systemic diseases or concomitant medication affecting salivary flow. * Cavitation of carious lesions. * Parafunctional habits. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remineralization | 6 months | measuring carious lesion development using DIAGNOdent laser fluorescence (scores from 0 to 99) according to progression of the carious lesion |
Countries
Egypt
Contacts
Primary ContactOmar O Shaalan, PhD
Outcome results
None listed