NCT02020681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 25, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

December 19, 2013

Last Update Submit

August 28, 2019

Conditions

Dental Caries

Keywords

Dental cariesCurodont RepairP11-4

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Difference in the change of Diagnodent Pen values between investigational medical device and placebo group.

    D0, D30, D90, D180, D270

  • Change in lesion's progression assessed by VAS between investigational medical device and placebo group.

    D0, D30, D90, D180, D270

Study Arms (2)

Curodont Repair

EXPERIMENTAL

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

Device: Curodont RepairDevice: Fluoride

Placebo

PLACEBO COMPARATOR

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

Other: PlaceboDevice: Fluoride

Interventions

Curodont RepairDEVICE

Self-assembling peptide, biomimetic re-mineralisation

Also known as: P11-4
Curodont Repair
PlaceboOTHER

Formulation of Curodont Repair without the peptide P11-4

Placebo
FluorideDEVICE

Single application on day D90

Curodont RepairPlacebo

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Geneva - Devision of Cariology and Endodontology

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Ivo Krejci, Prof. Dr.

    University of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 25, 2013

Study Start

September 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations

CH(1)