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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101255
• Other study ID #: P11-4-RACL
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: June 26, 2017

Study information

• Verified date: July 2018
• Source: Credentis AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 26, 2017
• Est. primary completion date: June 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Curodont Repair
Self-assembling peptide, biomimetic re-mineralisation Application on Day 0 and Day 360
• Fluoride
Application on Day 0, Day 180, Day 360, Day 540

Locations

Country	Name	City	State
Switzerland	Zahnheilkunde Seifert Gmbh	Sirnach	Thurgau

Sponsors (1)

Lead Sponsor	Collaborator
Credentis AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 360
Secondary	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.	Day 720