Effect of Curodont Repair in Patients With Early Approximal Carious Lesions

Credentis

Status

Completed

Conditions

Dental Caries

Treatments

Other: No treatment - control

Device: Curodont Repair

Study type

Interventional

Funder types

Industry

Identifiers

NCT02119507

P11-4-APCL

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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:

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