Clinical trial NCT02020681: Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions
Official title: Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions: A Mono-centre, Split-mouth, Double-blinded, Placebo Controlled, Randomised, Post Marketing Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Dental caries
Curodont Repair
P11-4
Lead sponsor: Credentis AG
Sponsor class: INDUSTRY
First posted: 2013-12-25
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early buccal carious lesions compared to placebo.

Detailed description: All study participants must have two early class V 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 placebo as control (single application). 3 months later fluoride (Duraphat) will be applied on both lesions. Study duration is 9 months. For assessment visual and tactile evaluation, pictures, ECM, Diagnodent Pen, Canary System, VAS is used.

Eligibility criteria: Inclusion Criteria:

* Two class V carious lesions which do not require an invasive treatment
* Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
* Patients must be able and willing to observe good oral hygiene throughout the study

  -≥ 20 teeth
* Permanent dentition and ≤ 65 years
* Willing and able to attend the on-study visits
* Willing and able to understand all study-related procedures
* Written informed consent before participation in the study
* Negative pregnancy test for women of childbearing potential

Exclusion Criteria:

* The two study lesions must not be on adjacent teeth
* No adjacent restoration on study tooth surface
* Fluoride varnish application \< 6 months prior to study treatment
* Patient suffers from diabetes
* Evidence of tooth erosion (due to excessive acidic drink consumption or reflux)
* 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 with an investigational drug or device or participation in another clinical trial with an investigational drug or device within 30 days prior to study entry
* Pregnant and lactating woman

Primary outcomes:
measure: The primary efficacy outcome is the difference of the change in the lesion size assessed by morphometry (standardised pictures) between investigational medical device and placebo group.
timeFrame: D0, D30, D90, D270
Secondary outcomes:
measure: Difference in the change of Diagnodent Pen values between investigational medical device and placebo group.
timeFrame: D0, D30, D90, D180, D270
measure: Change in lesion's progression assessed by VAS between investigational medical device and placebo group.
timeFrame: D0, D30, D90, D180, D270
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva - Devision of Cariology and Endodontology
Study officials:
affiliation: University of Geneva
name: Ivo Krejci, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: