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

Efficacy of Self-assembling Peptide P11-4 for the Treatment of Orthodontically Induced Initial Carious Lesions: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: White Spot Lesions
• Intervention / Treatment: Drug: Remineralization with SAP11-4; Drug: Remineralization with sodium fluoride varnish

Detailed Description

NCLs are common after orthodontic treatment and can persist as white spot lesions, presenting an aesthetic concern. Fluoride is a standard treatment, but it primarily benefits the outer enamel surface, while SAP11-4 may potentially enhance remineralization within the lesion body by mimicking enamel matrix proteins. This clinical study seeks to compare the effectiveness of two treatments for post-orthodontic non-cavitated carious lesions (NCLs): self-assembling peptide P11-4 (SAP11-4) and fluoride varnish. The goal is to evaluate which treatment is more effective at promoting remineralization of these lesions. The study utilizes the Quantitative Light-induced Fluorescence (QLF) camera to monitor changes in lesion size, severity, and mineralization. This method allows for a detailed assessment of the effectiveness of SAP11-4 compared to fluoride varnish or no treatment at all. The primary outcome of the study is the change in QLF parameters, which will be measured alongside the International Caries Detection and Assessment System (ICDAS) scores and the Nyvad criteria, providing a comprehensive clinical evaluation of the treatments' effects on the carious lesions.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1431
    • Medical University Sofia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• - Patients (18-30 y old) with ≥ 20 permanent teeth were included in the study.
• Presence of non-cavitated accessible carious enamel lesions on the vestibular surfaces (ICDAS II codes 1 and 2) after debonding of the fixed orthodontic appliances that do not require invasive treatment.
• The patients completed the fixed orthodontic therapy within the past 2 weeks [48].
• No professional topical fluoride application during the last 6 months prior the study.
• Patients are able and voluntarily attend the study visits and have a proper oral hygiene during the study.
• A written informed consent was signed before the start of the study.
• Female patients declare no pregnancy and breast feeding.
• Stimulated salivary flow rate ≥ 1 ml/min.
• The patients have lived in the same geographic region with constant fluoride concentration in the water during the last five years.

Exclusion Criteria:

• - Previously treated NCLs.
• Teeth with carious lesions placed apart from the fixed orthodontic appliances.
• Presence of restorations in contact with the carious lesion.
• Previous application of remineralizing agent <6 months prior to study treatment.
• Evidence of tooth erosion.
• Patients with dental fluorosis, enamel hypoplasia or tetracycline pigmentation.
• Present health conditions like diabetes, history of head and neck illnesses, metabolic disorders affecting bone turnover.
• Immunosuppression drugs.
• Pregnant and breast-feeding women.
• Significantly reduced salivation (unstimulated/stimulated); concomitant medication intake, affecting salivary flow.
• Concurrent participation in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No treatment
Experimental: Treatment of WSL with SAP11-4; WSL were treated with SAP11-4 corresponding to the manufacturer's instructions.	Drug: Remineralization with SAP11-4; The WSL were treated with SAP11-4 according to the manufacturer's instruction
Experimental: Treatment of WSL with sodium fluoride varnish; WSL were treated with sodium fluoride varnish corresponding to the manufacturer's instructions.	Drug: Remineralization with sodium fluoride varnish; The WSL were treated with sodium fluoride varnish according to the manufacturer's instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QLF measuerement of the lesion's depth	The depth of the lesion (parameter deltaF) was monitored throughout the study period.	Day 0, Day 120, Day 360
QLF measurement of the lesion's volume	The volume of the white spot lesion (parameter deltaQ) was monitored throughout the study period.	Day 0, Day 120, Day 360
QLF measurement of the lesion's Area	The size of the white spot lesion (parameter Area) was monitored throughout the study period.	Day 0, Day 120, Day 360

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Caries Detection and Assessment System (ICDAS) score changes	The changes of the white spot lesion score of the ICDAS system were monitored throughout of the study period.	Day 0, Day 120, Day 360
Caries activity assesment	The cnahges of the caries activity were monitored by the Nyvad criteria changes during the study period.	Day 0, Day 120, Day 360

Collaborators and Investigators

• Sponsor: Medical University of Sofia
• Investigators: Study Chair: Radosveta I Vasileva, Clinical Professor, Medical University, Sofia; Principal Investigator: Alexander B Bonchev, Chief Assistant Professor, Medical University, Sofia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: fluoride varnish; QLF; white spot; SAP11-4
• Additional Relevant MeSH Terms: Anti-Infective Agents; Physiological Effects of Drugs; Protective Agents; Anti-Infective Agents, Local; Cariostatic Agents; Fluorides; Listerine; Sodium Fluoride; Fluorides, Topical
• Other Study ID Numbers: 76/ 8717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Starting in January 2025 till June 2025
• IPD Sharing Access Criteria: The access is generally limited to individuals and organizations involved in the study, as well as other authorized researchers, under specific conditions ensuring privacy and ethical use, controlled by the researchers of the particular study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No