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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Device: Fluoride; Device: Curodont Repair

• Registration Number: NCT02101255
• Lead Sponsor: Credentis AG

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.

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-28
• Study First Posted: 2014-04-02
• Study Start: 2014-07
• Primary Completion: 2017-06-26
• Study Completion: 2017-06-26
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoride	Fluoride	Application on Day 0, Day 180, Day 360, Day 540
Curodont Repair	Curodont Repair	Application on Day 0 and Day 360

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Zahnheilkunde Seifert Gmbh; 🇨🇭 Sirnach, Thurgau, Switzerland