Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions

Credentis

Status: Completed

Conditions: Dental Caries

Treatments: Device: Curodont Repair; Device: Fluoride; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02020681

P11-4-CURAF

14934.1 PFLS-LS (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Curodont Repair

Experimental group

Description:

Single application of Curodont Repair on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.

Treatment:

Device: Fluoride

Device: Curodont Repair

Placebo

Placebo Comparator group

Description:

Single application of Placebo on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.

Treatment:

Device: Fluoride

Other: Placebo