White Spot LesionsNCT06749977
P11-4 and Fluoride Varnish for Remineralization of Post-orthodontic Lesions
A study testing Remineralization with SAP11-4 and Remineralization with sodium fluoride varnish in people with White Spot Lesions, run by Medical University of Sofia at 1 site in Bulgaria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- Remineralization with SAP11-4 and Remineralization with sodium fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Jan 2020to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - 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.
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- 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.
Who cannot join
- - 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- White Spot Lesions
- Being tested
- Remineralization with SAP11-4, Remineralization with sodium fluoride varnish
- Keywords
- white spot, SAP11-4, fluoride varnish, QLF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remineralization with SAP11-4Drug
The WSL were treated with SAP11-4 according to the manufacturer's instruction
Remineralization with sodium fluoride varnishDrug
The WSL were treated with sodium fluoride varnish according to the manufacturer's instruction
| Study group | Role | What they receive |
|---|---|---|
| Treatment of WSL with SAP11-4 | Experimental | WSL were treated with SAP11-4 corresponding to the manufacturer's instructions. Receives: 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. Receives: Drug: Remineralization with sodium fluoride varnish |
| No treatment | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
QLF measuerement of the lesion's depth
The depth of the lesion (parameter deltaF) was monitored throughout the study period.
Measured: 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.
Measured: 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.
Measured: Day 0, Day 120, Day 360
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 0, Day 120, Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Sofia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Bonchev, Medical University of Sofia
- Investigators
- Radosveta I Vasileva, Clinical Professor, Study chair, Medical University, SofiaAlexander B Bonchev, Chief Assistant Professor, Principal investigator, Medical University, Sofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749977
- Sponsor's protocol ID
- 76/ 8717
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Self-assembling Peptide P11-4 for the Treatment of Orthodontically Induced Initial Carious Lesions: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06749977
- Acronym / sponsor ID
- 76/ 8717
- Conditions
- White Spot Lesions
- Keywords
- white spot, SAP11-4, fluoride varnish, QLF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medical University of SofiaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment of WSL with SAP11-4 | Experimental | Drug: Remineralization with SAP11-4WSL were treated with SAP11-4 corresponding to the manufacturer's instructions. |
| Treatment of WSL with sodium fluoride varnish | Experimental | Drug: Remineralization with sodium fluoride varnishWSL were treated with sodium fluoride varnish corresponding to the manufacturer's instructions. |
| No treatment | No intervention | –No treatment |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- - 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.
Key exclusion criteria (11 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remineralization with SAP11-4The WSL were treated with SAP11-4 according to the manufacturer's instruction | Drug | Treatment of WSL with SAP11-4 |
| Remineralization with sodium fluoride varnishThe WSL were treated with sodium fluoride varnish according to the manufacturer's instruction | Drug | Treatment of WSL with sodium fluoride varnish |
Primary outcome
QLF measuerement of the lesion's depth
Time frame: Day 0, Day 120, Day 360
The depth of the lesion (parameter deltaF) was monitored throughout the study period.
QLF measurement of the lesion's volume
Time frame: Day 0, Day 120, Day 360
The volume of the white spot lesion (parameter deltaQ) was monitored throughout the study period.
QLF measurement of the lesion's Area
Time frame: Day 0, Day 120, Day 360
The size of the white spot lesion (parameter Area) was monitored throughout the study period.
2 secondary outcomes
International Caries Detection and Assessment System (ICDAS) score changes
Time frame: Day 0, Day 120, Day 360
Caries activity assesment
Time frame: Day 0, Day 120, Day 360
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radosveta I Vasileva, Clinical Professor study chair
Medical University, Sofia
Alexander B Bonchev, Chief Assistant Professor principal investigator
Medical University, Sofia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remineralization with SAP11-4 and Remineralization with sodium fluoride varnish in people with White Spot Lesions, run by Medical University of Sofia at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QLF measuerement of the lesion's depth (time frame: Day 0, Day 120, Day 360). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.