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Objectives: Occlusal surfaces of erupting permanent molars are highly prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.
Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups.
Objectives: Occlusal surfaces of erupting permanent molars are high prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.
Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups. Safety and applicability will be evaluated using dentist's/patient's questionnaires about adverse events, difficulties of application and satisfaction with procedure. Lesions will be assessed at baseline and recalls after 3 and 6 months regarding caries activity, clinical status (ICDAS-II) and with Diagnodent®. The Visual Analog Scale (VAS) of regression and of lesion size in addition to the Global Impression of Change Questionnaire will also be assessed. At every recall, fluoride varnish will be applied on lesions and patients received oral health instructions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) |
|
| control | Active Comparator | control group, only Fluoride varnish (Duraphat®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self assembling peptide P11-4 (Curodont™ Repair) | Device | Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device. | Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using LASER "Light Amplification by Stimulated Emission of Radiation" fluorescence readings by Diagnodent® device. Diagnodent® device measures the caries activity using LASER fluorescence of bacterial secretions in the caries lesion. The readings range from 0 to 99; 0 means no bacterial activity in the carious lesion whereas 99 refers to high bacterial and caries activity. Effect via the changes in LASER fluorescence readings between Baseline and 6-months recall (Change = Baseline value - 6 months value). Higher positive change value means caries regression, whereas lower positive or negative change value refers to caries progression. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale of Lesion Progression (VAS) | Visual Analog Scale of lesion progression (VAS), Effect via t test between Baseline and 6-months recall VAS values range from -100 % to +100 %. The value of -100 means that the carious lesion is strongly remineralising, the value of 0 means that the lesion is arrested, and the value of +100 means that the lesion is strongly progressing. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Alkilzy, Dr. PhD | University of Greifswald | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28892645 | Derived | Alkilzy M, Tarabaih A, Santamaria RM, Splieth CH. Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel. J Dent Res. 2018 Feb;97(2):148-154. doi: 10.1177/0022034517730531. Epub 2017 Sep 11. |
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No patient declined to participate
70 patients met the inclusion criteria and offered participation
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions |
| FG001 | Control | control group, only Fluoride varnish (Duraphat®) fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device. | Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using LASER "Light Amplification by Stimulated Emission of Radiation" fluorescence readings by Diagnodent® device. Diagnodent® device measures the caries activity using LASER fluorescence of bacterial secretions in the caries lesion. The readings range from 0 to 99; 0 means no bacterial activity in the carious lesion whereas 99 refers to high bacterial and caries activity. Effect via the changes in LASER fluorescence readings between Baseline and 6-months recall (Change = Baseline value - 6 months value). Higher positive change value means caries regression, whereas lower positive or negative change value refers to caries progression. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
6 months
Incidence of Treatment-Emergent Adverse Events (definitions are adapted from Directive 2001/20/EC and in accordance with ISO 14155 and MDD 93/42). Safety definitions are adapted from the Directive 2001/20/EC and in accordance with ISO 14155 and MDD 93/42.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohammad Alkilzy | University of Greifswald | 0049-17623399340 | alkilzym@uni-greifswald.de |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| fluoride varnish (Duraphat®) | Device | Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions |
|
| ICDAS Classification Index | Number of patients who have improvement on the ICDAS classification index (International Caries Detection and Assessment System), changes from Baseline to 6-months recall. This carries clinical index range from 0 to 6. The values mean: 0 No evidence of caries
| 6 months |
| Caries Activity Assessment According to Nyvad Criteria | Caries activity assessment according to Nyvad criteria, number of participants still have active lesions overall study. This assessment includes two clinical judgment inserts: active lesion or inactive lesion basing on visual-tactile surface characteristics of the caries lesions such as integrity, texture, translucency/opacity, lesion location, and surface color. During the study, an alteration from active lesion to in active lesion means an improvement. | 6 months |
| BG001 |
| Control |
control group, only Fluoride varnish (Duraphat®) fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)
self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions
fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions
| OG001 | Control | control group, only Fluoride varnish (Duraphat®) fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions |
|
|
| Secondary | Visual Analog Scale of Lesion Progression (VAS) | Visual Analog Scale of lesion progression (VAS), Effect via t test between Baseline and 6-months recall VAS values range from -100 % to +100 %. The value of -100 means that the carious lesion is strongly remineralising, the value of 0 means that the lesion is arrested, and the value of +100 means that the lesion is strongly progressing. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | ICDAS Classification Index | Number of patients who have improvement on the ICDAS classification index (International Caries Detection and Assessment System), changes from Baseline to 6-months recall. This carries clinical index range from 0 to 6. The values mean: 0 No evidence of caries
| Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Caries Activity Assessment According to Nyvad Criteria | Caries activity assessment according to Nyvad criteria, number of participants still have active lesions overall study. This assessment includes two clinical judgment inserts: active lesion or inactive lesion basing on visual-tactile surface characteristics of the caries lesions such as integrity, texture, translucency/opacity, lesion location, and surface color. During the study, an alteration from active lesion to in active lesion means an improvement. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control | control group, only Fluoride varnish (Duraphat®) fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions | 0 | 35 | 0 | 35 | 0 | 35 |
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