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

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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