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

Primary Purpose

Dental Caries

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Curodont Repair

Fluoride

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, Curodont Repair, P11-4

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
- 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

Sites / Locations

Zahnheilkunde Seifert Gmbh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Curodont Repair

Fluoride

Arm Description

Application on Day 0 and Day 360

Application on Day 0, Day 180, Day 360, Day 540

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Additional benefit of a second Curodont Repair application

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.

Full Information

NCT ID

NCT02101255

First Posted

March 21, 2014

Last Updated

July 17, 2018

Sponsor

Credentis AG

1. Study Identification

Unique Protocol Identification Number

NCT02101255

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

June 26, 2017 (Actual)

Study Completion Date

June 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Credentis AG

4. Oversight

Data Monitoring Committee

5. Study Description

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 fluoride.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

Dental caries, Curodont Repair, P11-4

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Curodont Repair

Arm Type

Experimental

Arm Description

Application on Day 0 and Day 360

Arm Title

Fluoride

Arm Type

Active Comparator

Arm Description

Application on Day 0, Day 180, Day 360, Day 540

Intervention Type

Device

Intervention Name(s)

Curodont Repair

Other Intervention Name(s)

P11-4

Intervention Description

Self-assembling peptide, biomimetic re-mineralisation Application on Day 0 and Day 360

Intervention Type

Device

Intervention Name(s)

Fluoride

Other Intervention Name(s)

Duraphat

Intervention Description

Application on Day 0, Day 180, Day 360, Day 540

Primary Outcome Measure Information:

Title

Opaqueness on X-Ray

Description

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

Secondary Outcome Measure Information:

Title

Additional benefit of a second Curodont Repair application

Description

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.

Time Frame

Day 720

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mathias Seifert, Med. dent.

Organizational Affiliation

Zahnheilkunde Seifert Gmbh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zahnheilkunde Seifert Gmbh

City

Sirnach

State/Province

Thurgau

ZIP/Postal Code

8370

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

23969679

Citation

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.

Results Reference

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

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