White Spot Lesion of ToothPhase 3NCT05206539
Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children
A Phase 3 study testing Self-assembling peptide (P11-4), CPP-ACFP and Resin infiltration in people with White Spot Lesion of Tooth, run by Plovdiv Medical University at 1 site in Bulgaria.
Trial summary
White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries. Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride… Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- Self-assembling peptide (P11-4), CPP-ACFP and Resin infiltration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Jun 2024to Apr 2025
- Phase
- Phase 3
- 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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants in the study are children 9 to 17 years old.
- Obtained written informed consent from parents or gave-givers as well as obtained verbal informed consent from the child to participate in the study, in which procedures are explained in age-appropriate manner.
- Children, identified as positive or definitely positive through Frankl behavioral rating scale.
- Presence of at least four initial carious lesions of smooth surface (white spots) in permanent teeth that reach the inside of the enamel but are not cavitated, estimated with ICDAS system values 01 (first visible enamel change) and 02 (localized visible enamel change), Nyvad caries activity criteria (1 -active, noncavited lesion) and DIAGNOdent pen values up to 24.
- Study participants did not conduct remineralizing or topical fluorine therapy of the lesions involved up to six months prior to inclusion in the study.
- Children without a history of allergy to the administered medications
Who cannot join
- Patients with general diseases or conditions associated with decreased salivation and intake of medications suppressing salivary current. Children with cognitive and behavioral disorders. The presence of a disease is confirmed by an anamnestic interview with the parent.
- Children with a history of allergy to the administered medications
- Patient with non-carious lesion such as enamel hypoplasia, or any developmental defects.
- Patient received restorations or any remineralizing agent other than the regular toothpaste during the last 6 months.
- Participant in another trial.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site, 1 recruiting
- Recruiting
Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv
Plovdiv, 4000
Irina Uzunova, +359899984312, iuzunova.raycheva@gmail.com
Irina Uzunova, DMD
About this study
Official title: Efficacy of Self-assembling Peptide P11-4, Casein Phosphopeptide - Amorphous Calcium Fluoride Phosphate and Resin Infiltrant in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children
White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries.
Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride phosphate (CPP-ACFP) and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients using visual assessments and laser fluorescence investigation.
Read the detailed description
White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries. These lesions are characterized by white chalky appearance. As caries is reversible under favorable conditions, many approaches have focused on treating it as soon as possible1.
Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride phosphate (CPP-ACFP) and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients. This will be achieved using visual assessments and laser fluorescence investigation.
The proposed study is a randomized controlled clinical trial with split-mouth design. Included are forty positive patients aged 9-17 years, with at least four visible WSL on smooth surfaces in permanent teeth, requiring non-operative treatment. WSL will be assessed visually by ICDAS II, Nyvad criteria and laser fluorescence (LF pen). The lesions are randomly assigned into 4 groups (n = 40): Gr NT (no treatment, control group), Gr CR (Curodont Repair), Gr V (MI Varnish), Gr I (Icon) groups. Lesions will be assessed by International Caries Detection and Assessment System, Nyvad caries activity criteria and laser fluorescence at baseline and follow-up period after1, 3, 6 and 12 months.
Data will be analyzed with intention-to-treat concept by Student T-test for paired samples, Wilcoxon signed rank test, P< .05. Pre-test on 20 subjects resulted in n=41 patients sample size.
- Conditions
- White Spot Lesion of Tooth
- Being tested
- Self-assembling peptide (P11-4), CPP-ACFP, Resin infiltration, Control Group, No Treatment
- Keywords
- white spot lesions, initial caries, early caries lesions, self-assembling peptide p11-4, cpp-acfp, resin infiltrant, icon infiltration, non-operative dental treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-assembling peptide (P11-4)Drug
Also called Curodont Repair
Prior to application, teeth are isolated by cotton rolls and gently air dried. The surface of the lesion is conditioned with a 2% sodium hypochlorite solution for 20 s and then rinse with water. Application of 35% phosphoric acid etching gel for 20 sec followed by rinsing with water-air spray for 30 sec. Drying the surface with compressed oil-free air for 60 sec. Curodont Repair is dissolve in 0.05 ml of distilled water and applied to the surface and allowed to work for about 5 min.
Participants will receive oral hygiene instructions.
CPP-ACFPDrug
Also called MI varnishTM (GC Corporation, Tokyo, Japan), RecaldentTM (CPP-ACP)
Prior to application, teeth are isolated by cotton rolls and gently air dried. Application of fluoride varnish with a brush applicator on the surface of the teeth for 5 minutes. Patients is advising not to brush their teeth or chew food for at least 4 h after treatment.
Participants will receive oral hygiene instructions
Resin infiltrationDrug
Also called Icon Vestibular (DMG; Hamburg, Germany)
The validated ICON Vestibular (DMG) infiltration lesion infiltration protocol is applied. Icon Etch (DMG) etching gel containing 15% hydrochloric acid is applied for 120 seconds using an applicator. It is then removed by rinsing thoroughly with water-air spray for 30 seconds. Then follows application of pure alcohol - Icon Dry (DMG) for 30 seconds for complete drying of the lesion and additional drying compressed oil-free air for 40 sec. Application of Icon Infiltrant (DMG) using a microapplicator allows it to penetrate for 3 minutes, during which, if necessary, it is reapplied several times. Excess material is removed with dry microbrushes and followed by light curing for 40 seconds. Re-applying of the infiltrate for 1 minute, removal of excess material, light curing for 40 seconds. Participants will receive oral hygiene instructions
Control Group, No TreatmentOther
Also called Home Oral Care
Everyday oral hygiene instructions Subjects will receive non-prescription fluoride toothpaste (1400 ppm Fluoride, Elmex junior) and oral hygiene instructions. The dosage will be 1/2 inch strip of paste 2x/day for 8 weeks. Subjects will apply paste to a toothbrush and brush teeth thoroughly for at least 1 minute then expectorate and rinse.
| Study group | Role | What they receive |
|---|---|---|
| SAP11-4 group (Gr CR) | Experimental | The Gr CR will receive treatment with Curodont RepairTM (Credentis; Windisch, Switzerland), according to the manufacturer's instructions. Receives: Drug: Self-assembling peptide (P11-4) |
| CPP-ACFP group (Gr V) | Active comparator | The Gr V will receive treatment with MI varnishTM (GC Corporation, Tokyo, Japan), according to the manufacturer's instructions. Receives: Drug: CPP-ACFP |
| Resin infiltration group (Gr I) | Active comparator | The Gr I receive treatment with Icon Vestibular (DMG, Germany), according to the manufacturer's instructions. Receives: Drug: Resin infiltration |
| Control group (Gr NT) | Placebo comparator | The control group (Gr NT) receive no intervention except brushing twice daily with aminofluoride toothpaste and toothbrush provided by researcher. Receives: Other: Control Group, No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lesion fluorescence evaluated using diode laser fluorescence device.
Laser fluorescence values are categorized: 20-24
- Category 0= LF values 0-7, caries-free enamel surface
- Category 1=LF values 8-14, caries extending up to halfway through the enamel
- Category 2=LF values 15-24, caries in the inner half of enamel
- Category 3= LF values >24, caries in dentine
Measured: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
Secondary outcomes (2)
Visual assessment using ICDAS II coding system
Code 0 Sound tooth surface:
Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel visible when wet, lesion must be visible when dry.
Code 3: Localized enamel breakdown because of caries with no visible dentin or underlying shadow.
Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown.
Code 5: Distinct cavity with visible dentin. Code 6: Extensive distinct cavity with visible dentin. After treatment, the evaluation will be performed as follows. If the score has increased to ICDAS 3 or more indicates caries progression and if it decreases to 0-1 this indicates caries regression; if score remains the same this indicates no change in lesion. No. of lesions with scores 0,1,2,3 or more will be assessed and analyzed.
Measured: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
Activity of a carious lesion using Nyvad Caries Diagnostic Criteria
Code 0: Sound - Normal enamel Code 1: Active caries (intact surface) - Surface of enamel is whitish/yellowish opaque Code 2: Active caries (surface discontinuity) Code 3: Active caries (cavity) - Enamel/dentin cavity easily visible with the naked eye.
Code 4: Inactive caries (intact surface) - Surface of enamel is whitish, brownish or black.
Code 5: Inactive caries (surface discontinuity) - Same criteria as score 4. Localized surface defect (microcavity) in enamel only Code 6: Inactive caries (cavity) - Enamel/dentin cavity easily visible with the naked eye; surface of cavity may be shiny and feels hard on probing with gentle pressure.
Code 7: Filling (sound surface) Code 8: Filling + active caries - Caries lesion may be cavitated or noncavitated.
Code 9: Filling + inactive caries - Caries lesion may be cavitated or noncavitated.
Measured: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Jun 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot Lesion of ToothStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The trial to be conducted is a randomized controlled clinical crossover experimental study with split-mouth design. The within-subject design randomly allocates experimental and control interventions to different areas in the oral cavity (teeth, surfaces, arches, quadrants) and has the advantage of reducing outcome variability estimation since each patient is its own control, leading to potential increase in statistical power.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ani Belcheva, PhD, Study director, Medical University Plovdiv, Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206539
- Sponsor's protocol ID
- MU_WSL
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Self-assembling Peptide P11-4, Casein Phosphopeptide - Amorphous Calcium Fluoride Phosphate and Resin Infiltrant in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children
- ClinicalTrials.gov ID
- NCT05206539
- Acronym / sponsor ID
- MU_WSL
- Conditions
- White Spot Lesion of Tooth
- Keywords
- white spot lesions, initial caries, early caries lesions, self-assembling peptide p11-4, cpp-acfp, resin infiltrant, icon infiltration, non-operative dental treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 25 Jan 2022 (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.
White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries.
Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride phosphate (CPP-ACFP) and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients using visual assessments and laser fluorescence investigation.
Detailed description
White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries. These lesions are characterized by white chalky appearance. As caries is reversible under favorable conditions, many approaches have focused on treating it as soon as possible1.
Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride phosphate (CPP-ACFP) and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients. This will be achieved using visual assessments and laser fluorescence investigation.
The proposed study is a randomized controlled clinical trial with split-mouth design. Included are forty positive patients aged 9-17 years, with at least four visible WSL on smooth surfaces in permanent teeth, requiring non-operative treatment. WSL will be assessed visually by ICDAS II, Nyvad criteria and laser fluorescence (LF pen). The lesions are randomly assigned into 4 groups (n = 40): Gr NT (no treatment, control group), Gr CR (Curodont Repair), Gr V (MI Varnish), Gr I (Icon) groups. Lesions will be assessed by International Caries Detection and Assessment System, Nyvad caries activity criteria and laser fluorescence at baseline and follow-up period after1, 3, 6 and 12 months.
Data will be analyzed with intention-to-treat concept by Student T-test for paired samples, Wilcoxon signed rank test, P< .05. Pre-test on 20 subjects resulted in n=41 patients sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- The trial to be conducted is a randomized controlled clinical crossover experimental study with split-mouth design. The within-subject design randomly allocates experimental and control interventions to different areas in the oral cavity (teeth, surfaces, arches, quadrants) and has the advantage of reducing outcome variability estimation since each patient is its own control, leading to potential increase in statistical power.
| Arm | Type | Receives |
|---|---|---|
| SAP11-4 group (Gr CR) | Experimental | Drug: Self-assembling peptide (P11-4)The Gr CR will receive treatment with Curodont RepairTM (Credentis; Windisch, Switzerland), according to the manufacturer's instructions. |
| CPP-ACFP group (Gr V) | Active comparator | Drug: CPP-ACFPThe Gr V will receive treatment with MI varnishTM (GC Corporation, Tokyo, Japan), according to the manufacturer's instructions. |
| Resin infiltration group (Gr I) | Active comparator | Drug: Resin infiltrationThe Gr I receive treatment with Icon Vestibular (DMG, Germany), according to the manufacturer's instructions. |
| Control group (Gr NT) | Placebo comparator | Other: Control Group, No TreatmentThe control group (Gr NT) receive no intervention except brushing twice daily with aminofluoride toothpaste and toothbrush provided by researcher. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participants in the study are children 9 to 17 years old.
- Obtained written informed consent from parents or gave-givers as well as obtained verbal informed consent from the child to participate in the study, in which procedures are explained in age-appropriate manner.
- Children, identified as positive or definitely positive through Frankl behavioral rating scale.
- Presence of at least four initial carious lesions of smooth surface (white spots) in permanent teeth that reach the inside of the enamel but are not cavitated, estimated with ICDAS system values 01 (first visible enamel change) and 02 (localized visible enamel change), Nyvad caries activity criteria (1 -active, noncavited lesion) and DIAGNOdent pen values up to 24.
- Study participants did not conduct remineralizing or topical fluorine therapy of the lesions involved up to six months prior to inclusion in the study.
Key exclusion criteria (5 listed)
- Patients with general diseases or conditions associated with decreased salivation and intake of medications suppressing salivary current. Children with cognitive and behavioral disorders. The presence of a disease is confirmed by an anamnestic interview with the parent.
- Children with a history of allergy to the administered medications
- Patient with non-carious lesion such as enamel hypoplasia, or any developmental defects.
- Patient received restorations or any remineralizing agent other than the regular toothpaste during the last 6 months.
- Participant in another trial.
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 |
|---|---|---|
| Self-assembling peptide (P11-4)Also: Curodont RepairPrior to application, teeth are isolated by cotton rolls and gently air dried. The surface of the lesion is conditioned with a 2% sodium hypochlorite solution for 20 s and then rinse with water. Application of 35% phosphoric acid etching gel for 20 sec followed by rinsing with water-air spray for 30 sec. Drying the surface with compressed oil-free air for 60 sec. Curodont Repair is dissolve in 0.05 ml of distilled water and applied to the surface and allowed to work for about 5 min. Participants will receive oral hygiene instructions. | Drug | SAP11-4 group (Gr CR) |
| CPP-ACFPAlso: MI varnishTM (GC Corporation, Tokyo, Japan), RecaldentTM (CPP-ACP)Prior to application, teeth are isolated by cotton rolls and gently air dried. Application of fluoride varnish with a brush applicator on the surface of the teeth for 5 minutes. Patients is advising not to brush their teeth or chew food for at least 4 h after treatment. Participants will receive oral hygiene instructions | Drug | CPP-ACFP group (Gr V) |
| Resin infiltrationAlso: Icon Vestibular (DMG; Hamburg, Germany)The validated ICON Vestibular (DMG) infiltration lesion infiltration protocol is applied. Icon Etch (DMG) etching gel containing 15% hydrochloric acid is applied for 120 seconds using an applicator. It is then removed by rinsing thoroughly with water-air spray for 30 seconds. Then follows application of pure alcohol - Icon Dry (DMG) for 30 seconds for complete drying of the lesion and additional drying compressed oil-free air for 40 sec. Application of Icon Infiltrant (DMG) using a microapplicator allows it to penetrate for 3 minutes, during which, if necessary, it is reapplied several times. Excess material is removed with dry microbrushes and followed by light curing for 40 seconds. Re-applying of the infiltrate for 1 minute, removal of excess material, light curing for 40 seconds. Participants will receive oral hygiene instructions | Drug | Resin infiltration group (Gr I) |
| Control Group, No TreatmentAlso: Home Oral CareEveryday oral hygiene instructions Subjects will receive non-prescription fluoride toothpaste (1400 ppm Fluoride, Elmex junior) and oral hygiene instructions. The dosage will be 1/2 inch strip of paste 2x/day for 8 weeks. Subjects will apply paste to a toothbrush and brush teeth thoroughly for at least 1 minute then expectorate and rinse. | Other | Control group (Gr NT) |
Primary outcome
Change in lesion fluorescence evaluated using diode laser fluorescence device.
Time frame: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
Laser fluorescence values are categorized: 20-24 * Category 0= LF values 0-7, caries-free enamel surface * Category 1=LF values 8-14, caries extending up to halfway through the enamel * Category 2=LF values 15-24, caries in the inner half of enamel * Category 3= LF values >24, caries in dentine
2 secondary outcomes
Visual assessment using ICDAS II coding system
Time frame: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
Activity of a carious lesion using Nyvad Caries Diagnostic Criteria
Time frame: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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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.
Ani Belcheva, PhD study director
Medical University Plovdiv, Bulgaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Self-assembling peptide (P11-4), CPP-ACFP and Resin infiltration in people with White Spot Lesion of Tooth, run by Plovdiv Medical University 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irina Uzunova, DMD (+359899984312, iuzunova.raycheva@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lesion fluorescence evaluated using diode laser fluorescence device. (time frame: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)). 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 9 May 2024.