Dental CariesNCT02020681
Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions
A study testing Curodont Repair and Fluoride in people with Dental Caries, run by Credentis AG at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Curodont Repair and Fluoride
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Geneva - Devision of Cariology and Endodontology
Geneva, 1205
About this study
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
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.
Read the 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
- Being tested
- Curodont Repair, Placebo, Fluoride
- Keywords
- Dental caries, Curodont Repair, P11-4
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curodont RepairDevice
Also called P11-4
Self-assembling peptide, biomimetic re-mineralisation
PlaceboOther
Formulation of Curodont Repair without the peptide P11-4
FluorideDevice
Single application on day D90
| Study group | Role | What they receive |
|---|---|---|
| Curodont Repair | Experimental | Single application of Curodont Repair on treatment day D0 followed by a single application of fluoride (Duraphat) on D90. Receives: Device: Curodont Repair; Device: Fluoride |
| Placebo | Placebo comparator | Single application of Placebo on treatment day D0 followed by a single application of fluoride (Duraphat) on D90. Receives: Other: Placebo; Device: Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: D0, D30, D90, D270
Secondary outcomes (2)
Difference in the change of Diagnodent Pen values between investigational medical device and placebo group.
only descriptively analysed
Measured: D0, D30, D90, D180, D270
Change in lesion's progression assessed by VAS between investigational medical device and placebo group.
only descriptively analysed
Measured: D0, D30, D90, D180, D270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Credentis AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivo Krejci, Prof. Dr., Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020681
- Sponsor's protocol ID
- P11-4-CURAF
- Other IDs
- 14934.1 PFLS-LS
- Status last verified
- Aug 2019
- First submitted
- 19 Dec 2013
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02020681
- Acronym / sponsor ID
- P11-4-CURAF
- Conditions
- Dental Caries
- Keywords
- Dental caries, Curodont Repair, P11-4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Credentis AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curodont Repair | Experimental | Device: Curodont Repair, Device: FluorideSingle application of Curodont Repair on treatment day D0 followed by a single application of fluoride (Duraphat) on D90. |
| Placebo | Placebo comparator | Other: Placebo, Device: FluorideSingle application of Placebo on treatment day D0 followed by a single application of fluoride (Duraphat) on D90. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curodont RepairAlso: P11-4Self-assembling peptide, biomimetic re-mineralisation | Device | Curodont Repair |
| PlaceboFormulation of Curodont Repair without the peptide P11-4 | Other | Placebo |
| FluorideSingle application on day D90 | Device | Curodont Repair, Placebo |
Primary outcome
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.
Time frame: D0, D30, D90, D270
Change of lesion size relative to baseline between study groups and different time points
2 secondary outcomes
Difference in the change of Diagnodent Pen values between investigational medical device and placebo group.
Time frame: D0, D30, D90, D180, D270
Change in lesion's progression assessed by VAS between investigational medical device and placebo group.
Time frame: D0, D30, D90, D180, D270
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivo Krejci, Prof. Dr. principal investigator
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curodont Repair and Fluoride in people with Dental Caries, run by Credentis AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: D0, D30, D90, D270). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.