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P11-4 and Fluoride Varnish for Remineralization of Post-orthodontic Lesions

NCT06749977 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-12-27

No results posted yet for this study

Summary

This clinical study aims to compare the remineralizing effects of self-assembling peptide P11-4 (SAP11-4) with fluoride varnish in the treatment of post-orthodontic non-cavitated carious lesions (NCLs). The study uses the QLF camera to assess changes in lesion size, severity, and mineralization, evaluating the effectiveness of SAP11-4 in comparison to fluoride varnish or no treatment. The primary endpoint is the change in QLF parameters, alongside ICDAS scores and Nyvad criteria for clinical evaluation.

Conditions

  • White Spot Lesions

Interventions

DRUG

Remineralization with SAP11-4

The WSL were treated with SAP11-4 according to the manufacturer's instruction

DRUG

Remineralization with sodium fluoride varnish

The WSL were treated with sodium fluoride varnish according to the manufacturer's instruction

Sponsors & Collaborators

  • Medical University of Sofia

    lead OTHER

Principal Investigators

  • Radosveta I Vasileva, Clinical Professor · Medical University, Sofia

  • Alexander B Bonchev, Chief Assistant Professor · Medical University, Sofia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-01-01
Completion
2023-02-20

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06749977 on ClinicalTrials.gov