This trial is active, not recruiting.

Condition dental caries
Treatments curodont repair, fluoride
Sponsor Credentis AG
Start date July 2014
End date December 2016
Trial size 25 participants
Trial identifier NCT02101255, P11-4-RACL


The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to fluoride.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Application on Day 0 and Day 360
curodont repair P11-4
Self-assembling peptide, biomimetic re-mineralisation Application on Day 0 and Day 360
(Active Comparator)
Application on Day 0, Day 180, Day 360, Day 540
fluoride Duraphat
Application on Day 0, Day 180, Day 360, Day 540

Primary Outcomes

Opaqueness on X-Ray
time frame: Day 360

Secondary Outcomes

Additional benefit of a second Curodont Repair application
time frame: Day 720

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Two approximal carious lesions on different teeth with at least one tooth in between 2. Both study lesions must not require an invasive treatment 3. Size and form of the lesions: the lesions must be fully visible and assessable on radiographs 4. The two carious lesions must fall into classes: - D2 (inner half of enamel) - D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction) 5. Able and willing to observe good oral hygiene throughout the study 6. Age ≥ 18 years and ≤ 65 years 7. Willing and able to attend the on-study visits 8. Willing and able to understand all study-related procedures 9. Written informed consent before participation in the study Exclusion Criteria: 1. The two study test lesions are located on adjacent teeth 2. Fluoride varnish application < 3 months prior to study treatment 3. Tooth with numerous carious lesions 4. Evidence of tooth erosion 5. History of head and neck illnesses (e.g. head/neck cancer) 6. Any pathology or concomitant medication affecting salivary flow or dry mouth 7. Any metabolic disorders affecting bone turnover 8. Patient suffers from diabetes 9. Concurrent participation in another clinical trial 10. Women who are breast-feeding, pregnant or who plan a pregnancy during the study 11. Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner

Additional Information

Official title Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Split-mouth, Post-marketing Study
Principal investigator Mathias Seifert, Med. dent.
Description All study participants must have two early approximal carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). One lesion will be treated with Curodont Repair and one with fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam is used.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Credentis AG.