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Effect of Curodont Repair in Patients With Early Approximal Carious Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02119507
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : January 27, 2016
Information provided by (Responsible Party):
Credentis AG

Brief Summary:
The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to no treatment.

Condition or disease Intervention/treatment Phase
Dental Caries Device: Curodont Repair Other: No treatment - control Not Applicable

Detailed Description:
All study participants must have two early approximal 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 the other will not undergo a treatment as control. Study duration is 12 months. For assessment x-ray pictures are used.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Curodont Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Post-marketing Study
Study Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: Curodont Repair
Single application on Day 0.
Device: Curodont Repair
Single application on Day 0
Other Name: P11-4

No treatment - control
No treatment as control - "wait and see".
Other: No treatment - control

Primary Outcome Measures :
  1. Opaqueness on X-Ray [ Time Frame: Day 360 ]
    The primary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 0 to Day 365 between test and control group.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Two approximal carious lesions on different teeth with at least one tooth in between
  • Both study lesions must not require an invasive treatment
  • Size and form of the lesions: the lesions must be fully visible and assessable on radiographs
  • The two carious lesions must fall into classes:

D1 (outer half of enamel) D2 (inner half of enamel) D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction)

  • Able and willing to observe good oral hygiene throughout the study
  • Age ≥ 18 years 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

Exclusion Criteria:

  • The two study test lesions are located on adjacent teeth
  • Fluoride varnish application < 3 months prior to study treatment
  • Tooth with numerous carious lesions
  • Evidence of tooth erosion
  • 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
  • Patient suffers from diabetes
  • Concurrent participation in another clinical trial
  • Women who are breast-feeding, pregnant or who plan a pregnancy during the study
  • Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02119507

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Zumstein Dental Clinic Ag
Luzern, Switzerland, 6003
Sponsors and Collaborators
Credentis AG
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Principal Investigator: Rolf Heimlinger, Dr. med. dent. zumstein dental clinic ag
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Responsible Party: Credentis AG Identifier: NCT02119507    
Other Study ID Numbers: P11-4-APCL
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Keywords provided by Credentis AG:
Dental caries
Curodont Repair
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases