Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: nano-eggshell varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental Paste, Sodium Fluoride Varnish (5%).
- Who it may be relevant to
- Registry conditions: Initial Dental Caries. Basic parameters: 15 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries: Randomized Controlled Trial
Overview
This randomized controlled clinical trial aims to evaluate and compare the remineralizing effect of nano-eggshell varnish, CPP-ACP paste (GC Tooth Mousse), and sodium fluoride varnish on initial enamel caries among adolescents aged 15-20 years. Participants will be randomly allocated into three groups. Remineralization and caries activity will be assessed using DIAGNOdent readings, International Caries Classification and Management System (ICCMS) criteria, and the decayed, missed, and filled surfaces (DMFS) index over a 12-month follow-up period.
Interventions
- Drug nano-eggshell varnish
Nano-eggshell varnish is applied topically to tooth surfaces every 3 months, according to manufacturer instructions, to promote the remineralization of initial enamel caries. - Drug Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental Paste
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) paste was applied daily by participants after tooth brushing at bedtime and left on teeth for at least 3 minutes before rinsing. - Drug Sodium Fluoride Varnish (5%)
5% sodium fluoride varnish is applied topically every 3 months according to manufacturer instructions as a controlled remineralizing agent.
Primary outcome measures
- Change in remineralization of initial enamel caries [Time frame: Baseline to 12 months]
- Change in DIAGNOdent readings [Time frame: Baseline, 3, 6, 9, and 12 months]
Secondary outcome measures (2)
- Caries activity assessment using ICCMS criteria [Time frame: Baseline, 3, 6, 9, and 12 months]
- Change in the Decayed, Missing, and Filled Surfaces (DMFS) index [Time frame: baseline, after 6 and 12 months]
Eligibility criteria
Inclusion criteria
Patients' ages should be 15-20 years. Patients should have at least three to four teeth with ICDAS II scores of 1-2. Patients should have moderate-to-high caries risk.
Exclusion criteria
Known hypersensitivity to one of the components of the material under study. Systemic disorders or medication interfering with normal salivary flow.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry, Mansoura University — Al Mansurah
Publications
- Sarhan M, El Baz M, Hamza O. Remineralization effect of eggshell powder on post-orthodontic white spot lesions compared to CPP-ACP: a randomized controlled clinical trial. Egyptian Dental Journal. 2021. 67(3): 2701-2710.
Identifiers
NCT: NCT07711132 · M0409023PP