Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions

NCT ID: NCT02020681

Last Updated: 2019-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-01-31

Brief Summary

The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early buccal carious lesions compared to placebo.

Detailed Description

All study participants must have two early class V 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 placebo as control (single application). 3 months later fluoride (Duraphat) will be applied on both lesions. Study duration is 9 months. For assessment visual and tactile evaluation, pictures, ECM, Diagnodent Pen, Canary System, VAS is used.

Conditions

Dental Caries

Study Design

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

Study Groups

Curodont Repair

Single application of Curodont Repair on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.

Group Type: EXPERIMENTAL

Curodont Repair

Intervention Type: DEVICE

Self-assembling peptide, biomimetic re-mineralisation

Fluoride

Intervention Type: DEVICE

Single application on day D90

Placebo

Single application of Placebo on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Formulation of Curodont Repair without the peptide P11-4

Fluoride

Intervention Type: DEVICE

Single application on day D90

Interventions

Curodont Repair

Self-assembling peptide, biomimetic re-mineralisation

Intervention Type: DEVICE

Placebo

Formulation of Curodont Repair without the peptide P11-4

Intervention Type: OTHER

Fluoride

Single application on day D90

Intervention Type: DEVICE

Other Intervention Names

P11-4

Eligibility Criteria

Inclusion Criteria

• Two class V carious lesions which do not require an invasive treatment
• Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
• Patients must be able and willing to observe good oral hygiene throughout the study

-≥ 20 teeth

• Permanent dentition 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
• Negative pregnancy test for women of childbearing potential

Exclusion Criteria

• The two study lesions must not be on adjacent teeth
• No adjacent restoration on study tooth surface
• Fluoride varnish application < 6 months prior to study treatment
• Patient suffers from diabetes
• Evidence of tooth erosion (due to excessive acidic drink consumption or reflux)
• 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
• Concurrent participation in another clinical trial with an investigational drug or device or participation in another clinical trial with an investigational drug or device within 30 days prior to study entry
• Pregnant and lactating woman

• Minimum Eligible Age: 14 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

Ivo Krejci, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Locations

University of Geneva - Devision of Cariology and Endodontology

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

14934.1 PFLS-LS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

P11-4-CURAF

Identifier Type: -

Identifier Source: org_study_id