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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Credentis AG
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Curodont Repair
Single application of Curodont Repair on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.
Intervention: Curodont Repair (Device)
Curodont Repair
Single application of Curodont Repair on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.
Intervention: Fluoride (Device)
Placebo
Single application of Placebo on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.
Intervention: Placebo (Other)
Placebo
Single application of Placebo on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.
Intervention: Fluoride (Device)
Outcomes
Primary Outcomes
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.
Time Frame: D0, D30, D90, D270
Change of lesion size relative to baseline between study groups and different time points
Secondary Outcomes
- Difference in the change of Diagnodent Pen values between investigational medical device and placebo group.(D0, D30, D90, D180, D270)
- Change in lesion's progression assessed by VAS between investigational medical device and placebo group.(D0, D30, D90, D180, D270)