A Phase 3 interventional study of Self-assembling peptide (P11-4) and CPP-ACFP in White Spot Lesion of Tooth, sponsored by Plovdiv Medical University. Recruiting at 1 site in Bulgaria. Open to participants aged 9 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Plovdiv Medical University · Phase 3, Interventional, and Treatment
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.
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.
Plovdiv Medical University is the lead sponsor of 16 studies on the registry; 5 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Gr CR will receive treatment with Curodont RepairTM (Credentis; Windisch, Switzerland), according to the manufacturer's instructions.
Drug: Self-assembling peptide (P11-4)
The Gr V will receive treatment with MI varnishTM (GC Corporation, Tokyo, Japan), according to the manufacturer's instructions.
Drug: CPP-ACFP
The Gr I receive treatment with Icon Vestibular (DMG, Germany), according to the manufacturer's instructions.
Drug: Resin infiltration
The control group (Gr NT) receive no intervention except brushing twice daily with aminofluoride toothpaste and toothbrush provided by researcher.
Other: Control Group, No Treatment
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.
Also known as: Curodont Repair
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
Also known as: MI varnishTM (GC Corporation, Tokyo, Japan), RecaldentTM (CPP-ACP)
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
Also known as: Icon Vestibular (DMG; Hamburg, Germany)
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.
Also known as: Home Oral Care
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
Time frame: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
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.
Time frame: 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.
Time frame: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
Plan to share: No
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Start is estimated for Jun 2024; primary completion for Mar 2025, 9 months later.
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Plovdiv Medical University