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CompletedNCT02119507Updated Jan 27, 2016

Effect of Curodont Repair in Patients With Early Approximal Carious Lesions

An interventional study of Curodont Repair and No treatment - control in Dental Caries, sponsored by Credentis AG. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-01-27.

Sponsored by Credentis AG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Caries

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Keywords

  • Dental caries
  • Curodont Repair
  • P11-4
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 25 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Credentis AG is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Curodont Repair

    Single application on Day 0.

    Device: Curodont Repair

  • Other
    No treatment - control

    No treatment as control - "wait and see".

    Other: No treatment - control

Interventions

  • DeviceCurodont Repair

    Single application on Day 0

    Also known as: P11-4

  • OtherNo treatment - control
06

What researchers measure

Primary outcomes

  1. Opaqueness on X-Ray

    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.

    Time frame: Day 360

07

Study locations

1 site
  • Zumstein Dental Clinic Ag
    Luzern, 6003, Switzerland
08

References and documents

Publications

  • Brunton PA, Davies RP, Burke JL, Smith A, Aggeli A, Brookes SJ, Kirkham J. Treatment of early caries lesions using biomimetic self-assembling peptides--a clinical safety trial. Br Dent J. 2013 Aug;215(4):E6. doi: 10.1038/sj.bdj.2013.741. PubMed 23969679 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02119507
Lead sponsor
Credentis AG
Responsible party
Sponsor
First posted
Apr 21, 2014
Start date
Apr 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jan 27, 2016

Study contacts

Rolf Heimlinger, Dr. med. dent.
principal investigator · zumstein dental clinic ag

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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