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

NCT06749977 | Completed DMC

• 1 other identifier: 76/ 8717
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

White Spot Lesions

Keywords

white spot; SAP11-4; fluoride varnish; QLF

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• International Caries Detection and Assessment System (ICDAS) score changes

  Day 0, Day 120, Day 360

• Caries activity assesment

  Day 0, Day 120, Day 360

Study Arms (3)

Treatment of WSL with SAP11-4

EXPERIMENTAL

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

Drug: Remineralization with SAP11-4

Treatment of WSL with sodium fluoride varnish

EXPERIMENTAL

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

Drug: Remineralization with sodium fluoride varnish

No treatment

NO INTERVENTION

No treatment

Interventions

Remineralization with SAP11-4 DRUG

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

Treatment of WSL with SAP11-4

Remineralization with sodium fluoride varnish DRUG

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

Treatment of WSL with sodium fluoride varnish

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Medical University of Sofia: lead

Study Sites (1)

Medical University Sofia

Sofia, 1431, Bulgaria

Location

MeSH Terms

Interventions

splicing factor 3a

Study Officials

• Radosveta I Vasileva, Clinical Professor

  Medical University, Sofia

  STUDY CHAIR

• Alexander B Bonchev, Chief Assistant Professor

  Medical University, Sofia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Assistant Professor Dr Alexander Bonchev, DMD, PhD

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 20, 2023
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting in January 2025 till June 2025
• 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.

Locations

BU (1)