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Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions

Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions Among a Group of Egyptian Children : A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05064137
Enrollment
30
Registered
2021-10-01
Start date
2022-03-31
Completion date
2023-01-31
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Remineralization

Brief summary

The aim of the present study is to evaluate the efficiency of Self-assembling Peptide P11-4, Tricalcium Phosphate Fluoride Varnish, 5% F- and 5% fluoride varnish in remineralization of WSLs in primary dentition among a group of Egyptian children.

Interventions

DRUGMonomeric self - assembling peptide P11-4

Monomeric self - assembling peptide P11-4 ( Curodont Repair ) is a remineralizing agent applied on tooth surface after treating it with 3% sodium hypochlorite for 20 seconds then etching it with 37% phosphoric acid for 20 seconds followed by rinsing then dryness.

DRUGTricalcium phosphate fluoride varnish, 5% F-

Tricalcium phosphate fluoride varnish, 5% F- ( Clinpro White Varnish ) is a remineralizing agent applied on tooth surface after mixing it with a brush onto the dosage guide.

fluoride varnish (5% sodium fluoride) ( Voco-profluorid ) is a remineralizing agent applied on tooth surface then area is allowed to become wet (either by gentle rinsing or natural salivary flow) to ensure setting of VOCO Profluorid Varnish.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Double blinded ( participant and statistician )

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* Apparently healthy cooperative children * Aging from 3-5 years old child * Both genders * Primary teeth with active WSLs on buccal or labial surfaces * Patient and parent acceptance to treatment and maintenance of good oral hygiene

Exclusion criteria

* Restored teeth * White spot lesions due to fluorosis * Teeth with hypoplasia * Lesions that require an invasive treatment * Any pathology or concomitant medication affecting salivary flow or causing dry mouth

Design outcomes

Primary

MeasureTime frameDescription
Size of WSL ( white spot lesion )through study completion, an average of 8 monthsSize of WSL measured by scored dental probe

Secondary

MeasureTime frameDescription
Regression of cariesthrough study completion, an average of 8 monthsRegression of caries evaluated by International Caries Detection and Assessment System (ICDAS) II
Inactivation of active carious lesionsthrough study completion, an average of 8 monthsInactivation of active carious lesions evaluated by Lesion activity assessment (LAA-ICDAS)
Mineral content of WSLthrough study completion, an average of 8 monthsMineral content of WSL measured by fluorescence camera VistaCam iX

Contacts

Primary ContactYara A Abdellatif, BDS
yaraabdellatif@dentistry.cu.edu.eg00201007627551
Backup ContactRasha Hatem, PHD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026