NCT02101255

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

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

First Submitted

Initial submission to the registry

March 21, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2017

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

March 21, 2014

Last Update Submit

July 17, 2018

Conditions

Dental Caries

Keywords

Dental cariesCurodont RepairP11-4

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Additional benefit of a second Curodont Repair application

    Day 720

Study Arms (2)

Curodont Repair

EXPERIMENTAL

Application on Day 0 and Day 360

Device: Curodont Repair

Fluoride

ACTIVE COMPARATOR

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

Device: Fluoride

Interventions

Curodont RepairDEVICE

Self-assembling peptide, biomimetic re-mineralisation Application on Day 0 and Day 360

Also known as: P11-4
Curodont Repair
FluorideDEVICE

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

Also known as: Duraphat
Fluoride

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Two approximal carious lesions on different teeth with at least one tooth in between
  • Both study lesions must not require an invasive treatment
  • Size and form of the lesions: the lesions must be fully visible and assessable on radiographs
  • 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)
  • Able and willing to observe good oral hygiene throughout the study
  • Age ≥ 18 years 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

You may not qualify if:

  • The two study test lesions are located on adjacent teeth
  • Fluoride varnish application \< 3 months prior to study treatment
  • Tooth with numerous carious lesions
  • Evidence of tooth erosion
  • 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
  • Patient suffers from diabetes
  • Concurrent participation in another clinical trial
  • Women who are breast-feeding, pregnant or who plan a pregnancy during the study
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zahnheilkunde Seifert Gmbh

Sirnach, Thurgau, 8370, Switzerland

Location

Related 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.

    PMID: 23969679BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Mathias Seifert, Med. dent.

    Zahnheilkunde Seifert Gmbh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2014

First Posted

April 2, 2014

Study Start

July 1, 2014

Primary Completion

June 26, 2017

Study Completion

June 26, 2017

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

CH(1)