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

NCT ID: NCT06749977

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-02-20

Brief Summary

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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

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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.

Conditions

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White Spot Lesions

Keywords

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white spot SAP11-4 fluoride varnish QLF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment of WSL with SAP11-4

WSL were treated with SAP11-4 corresponding to the manufacturer's instructions.

Group Type EXPERIMENTAL

Remineralization with SAP11-4

Intervention Type DRUG

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

Treatment of WSL with sodium fluoride varnish

WSL were treated with sodium fluoride varnish corresponding to the manufacturer's instructions.

Group Type EXPERIMENTAL

Remineralization with sodium fluoride varnish

Intervention Type DRUG

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

No treatment

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remineralization with SAP11-4

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

Intervention Type DRUG

Remineralization with sodium fluoride varnish

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Sofia

OTHER

Sponsor Role lead

Responsible Party

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Alexander Bonchev

Chief Assistant Professor Dr Alexander Bonchev, DMD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Radosveta I Vasileva, Clinical Professor

Role: STUDY_CHAIR

Medical University, Sofia

Alexander B Bonchev, Chief Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Medical University, Sofia

Locations

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Medical University Sofia

Sofia, , Bulgaria

Site Status

Countries

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Bulgaria

Other Identifiers

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76/ 8717

Identifier Type: -

Identifier Source: org_study_id