Clinical trial NCT06749977: P11-4 and Fluoride Varnish for Remineralization of Post-orthodontic Lesions
Official title: Efficacy of Self-assembling Peptide P11-4 for the Treatment of Orthodontically Induced Initial Carious Lesions: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesions
Keywords: white spot
SAP11-4
fluoride varnish
QLF
Lead sponsor: Medical University of Sofia
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: QLF measuerement of the lesion's depth
timeFrame: Day 0, Day 120, Day 360
measure: QLF measurement of the lesion's volume
timeFrame: Day 0, Day 120, Day 360
measure: QLF measurement of the lesion's Area
timeFrame: Day 0, Day 120, Day 360
Secondary outcomes:
measure: International Caries Detection and Assessment System (ICDAS) score changes
timeFrame: Day 0, Day 120, Day 360
measure: Caries activity assesment
timeFrame: Day 0, Day 120, Day 360
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Medical University Sofia
Study officials:
affiliation: Medical University, Sofia
name: Radosveta I Vasileva, Clinical Professor
role: STUDY_CHAIR
affiliation: Medical University, Sofia
name: Alexander B Bonchev, Chief Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References: