Effect of Curodont Repair in Patients With Early Approximal Carious Lesions

January 26, 2016 updated by: Credentis AG

Effect of Curodont Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Post-marketing Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Luzern, Switzerland, 6003
        • Zumstein Dental Clinic Ag

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Curodont Repair
Single application on Day 0.
Device: Curodont Repair
Single application on Day 0
Other Names:
  • P11-4
Other: No treatment - control
No treatment as control - "wait and see".
Other: No treatment - control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Credentis AG

Investigators

  • Principal Investigator: Rolf Heimlinger, Dr. med. dent., Zumstein Dental Clinic Ag

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P11-4-APCL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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