Phase 2
N=70
Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT02724592 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device. — 18.6; 1.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- self assembling peptide P11-4 (Curodont™ Repair) (Device); fluoride varnish (Duraphat®) (Device)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- University Medicine Greifswald
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device. |
18.6; 1.1 | — |
| SECONDARY Visual Analog Scale of Lesion Progression (VAS) |
88.0; 49.1 | — |
| SECONDARY ICDAS Classification Index |
9; 2 | — |
| SECONDARY Caries Activity Assessment According to Nyvad Criteria |
6; 21 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Early occlusal carious lesions (without cavity) on permanent molar "6" or "7" at eruption which does not require an invasive treatment
- Age ≥ 5 years
- Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
- Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
- Written informed consent before participation in the study
Exclusion Criteria
- Evidence of tooth erosion
- Fluoride varnish application < 3 months prior to study treatment
- History of head and neck illnesses (e.g. head/neck cancer)
- Any pathology or concomitant medication affecting salivary flow or dry mouth
- Any metabolic disorders affecting bone turnover
- Concurrent participation in another clinical trial
Data sourced from ClinicalTrials.gov (NCT02724592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.