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

Sponsor

Credentis AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02101255

Collaborator

(none)

Enrollment

Location

Arms

35.8

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Device: Curodont Repair Device: Fluoride	N/A

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.

Study Design

Study Type:

Interventional

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, Split-mouth, Post-marketing Study

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jun 26, 2017

Actual Study Completion Date :

Jun 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Duraphat

Arm

Intervention/Treatment

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 Names:

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 Names:

Duraphat

Outcome Measures

Primary Outcome Measures

Opaqueness on X-Ray [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.

Secondary Outcome Measures

Additional benefit of a second Curodont Repair application [Day 720]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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