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

NCT ID: NCT02101255

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-06-26

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Curodont Repair

Application on Day 0 and Day 360

Group Type: EXPERIMENTAL

Curodont Repair

Intervention Type: DEVICE

Self-assembling peptide, biomimetic re-mineralisation

Application on Day 0 and Day 360

Fluoride

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

Group Type: ACTIVE_COMPARATOR

Fluoride

Intervention Type: DEVICE

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

Interventions

Curodont Repair

Self-assembling peptide, biomimetic re-mineralisation

Application on Day 0 and Day 360

Intervention Type: DEVICE

Fluoride

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

Intervention Type: DEVICE

Other Intervention Names

P11-4; Duraphat

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Credentis AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathias Seifert, Med. dent.

Role: PRINCIPAL_INVESTIGATOR

Zahnheilkunde Seifert Gmbh

Locations

Zahnheilkunde Seifert Gmbh

Sirnach, Thurgau, Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 23969679 (View on PubMed)

Other Identifiers

P11-4-RACL

Identifier Type: -

Identifier Source: org_study_id