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

Dental Caries Clinical Trial

Official title:

Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions: A Mono-centre, Split-mouth, Double-blinded, Placebo Controlled, Randomised, Post Marketing Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020681
• Other study ID #: P11-4-CURAF
• Secondary ID: 14934.1 PFLS-LS
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: January 2016

Study information

• Verified date: August 2019
• 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 buccal carious lesions compared to placebo.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Curodont Repair
Self-assembling peptide, biomimetic re-mineralisation

Other:
• Placebo
Formulation of Curodont Repair without the peptide P11-4

Device:
• Fluoride
Single application on day D90

Locations

Country	Name	City	State
Switzerland	University of Geneva - Devision of Cariology and Endodontology	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Credentis AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy outcome is the difference of the change in the lesion size assessed by morphometry (standardised pictures) between investigational medical device and placebo group.	Change of lesion size relative to baseline between study groups and different time points	D0, D30, D90, D270
Secondary	Difference in the change of Diagnodent Pen values between investigational medical device and placebo group.	only descriptively analysed	D0, D30, D90, D180, D270
Secondary	Change in lesion's progression assessed by VAS between investigational medical device and placebo group.	only descriptively analysed	D0, D30, D90, D180, D270