Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Credentis AG
Sponsor:
Information provided by (Responsible Party):
Credentis AG
ClinicalTrials.gov Identifier:
NCT02101255
First received: March 21, 2014
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to fluoride.


Condition Intervention
Dental Caries
Device: Curodont Repair
Device: Fluoride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Split-mouth, Post-marketing Study

Resource links provided by NLM:


Further study details as provided by Credentis AG:

Primary Outcome Measures:
  • Opaqueness on X-Ray [ Time Frame: Day 360 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Additional benefit of a second Curodont Repair application [ Time Frame: Day 720 ] [ Designated as safety issue: No ]
    The secondary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 360 to Day 720 between test and control group.


Estimated Enrollment: 25
Study Start Date: May 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Curodont Repair
Application on Day 0 and Day 360
Device: Curodont Repair

Self-assembling peptide, biomimetic re-mineralisation

Application on Day 0 and Day 360

Other Name: P11-4
Active Comparator: Fluoride
Application on Day 0, Day 180, Day 360, Day 540
Device: Fluoride
Application on Day 0, Day 180, Day 360, Day 540
Other Name: Duraphat

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 one with fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam is used.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    • D2 (inner half of enamel)
    • D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction)
  5. Able and willing to observe good oral hygiene throughout the study
  6. Age ≥ 18 years and ≤ 65 years
  7. Willing and able to attend the on-study visits
  8. Willing and able to understand all study-related procedures
  9. Written informed consent before participation in the study

Exclusion Criteria:

  1. The two study test lesions are located on adjacent teeth
  2. Fluoride varnish application < 3 months prior to study treatment
  3. Tooth with numerous carious lesions
  4. Evidence of tooth erosion
  5. History of head and neck illnesses (e.g. head/neck cancer)
  6. Any pathology or concomitant medication affecting salivary flow or dry mouth
  7. Any metabolic disorders affecting bone turnover
  8. Patient suffers from diabetes
  9. Concurrent participation in another clinical trial
  10. Women who are breast-feeding, pregnant or who plan a pregnancy during the study
  11. 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02101255

Contacts
Contact: Mathias Seifert, Med. dent. +41 71 966 55 44 mathias.seifert@zahnarzt-sirnach.ch

Locations
Switzerland
Zahnheilkunde Seifert Gmbh Not yet recruiting
Sirnach, Thurgau, Switzerland, 8370
Contact: Mathias Seifert, Med. dent.    +41 71 966 55 44    mathias.seifert@zahnarzt-sirnach.ch   
Principal Investigator: Mathias Seifert, Med. dent.         
Sponsors and Collaborators
Credentis AG
Investigators
Principal Investigator: Mathias Seifert, Med. dent. Zahnheilkunde Seifert Gmbh
  More Information

Publications:
Responsible Party: Credentis AG
ClinicalTrials.gov Identifier: NCT02101255     History of Changes
Other Study ID Numbers: P11-4-RACL
Study First Received: March 21, 2014
Last Updated: March 28, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Credentis AG:
Dental caries
Curodont Repair
P11-4

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Fluorides
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 22, 2014