Back to resultsEffect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Curodont Repair
Placebo
Fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, Curodont Repair, P11-4
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
Sites / Locations
- University of Geneva - Devision of Cariology and Endodontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Curodont Repair
Placebo
Arm Description
Single application of Curodont Repair on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.
Single application of Placebo on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.
Outcomes
Primary Outcome Measures
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.
Change of lesion size relative to baseline between study groups and different time points
Secondary Outcome Measures
Difference in the change of Diagnodent Pen values between investigational medical device and placebo group.
only descriptively analysed
Change in lesion's progression assessed by VAS between investigational medical device and placebo group.
only descriptively analysed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02020681
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Credentis AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental caries, Curodont Repair, P11-4
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curodont Repair
Arm Type
Experimental
Arm Description
Single application of Curodont Repair on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single application of Placebo on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.
Intervention Type
Device
Intervention Name(s)
Curodont Repair
Other Intervention Name(s)
P11-4
Intervention Description
Self-assembling peptide, biomimetic re-mineralisation
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Formulation of Curodont Repair without the peptide P11-4
Intervention Type
Device
Intervention Name(s)
Fluoride
Intervention Description
Single application on day D90
Primary Outcome Measure Information:
Title
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.
Description
Change of lesion size relative to baseline between study groups and different time points
Time Frame
D0, D30, D90, D270
Secondary Outcome Measure Information:
Title
Difference in the change of Diagnodent Pen values between investigational medical device and placebo group.
Description
only descriptively analysed
Time Frame
D0, D30, D90, D180, D270
Title
Change in lesion's progression assessed by VAS between investigational medical device and placebo group.
Description
only descriptively analysed
Time Frame
D0, D30, D90, D180, D270
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivo Krejci, Prof. Dr.
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Geneva - Devision of Cariology and Endodontology
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions
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