Dental CariesNCT02101255
Effect of Curodont™ Repair in Patients With Early Approximal 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 approximal carious lesions compared to fluoride. Read more about this study
- Who is it for?
- Ages 18 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?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2014to 26 Jun 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Split-mouth, Post-marketing Study
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.
Read the detailed description
All study participants must have two early approximal 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 fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam is used.
- Conditions
- Dental Caries
- Being tested
- Curodont Repair, 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
Application on Day 0 and Day 360
FluorideDevice
Also called Duraphat
Application on Day 0, Day 180, Day 360, Day 540
| Study group | Role | What they receive |
|---|---|---|
| Curodont Repair | Experimental | Application on Day 0 and Day 360 Receives: Device: Curodont Repair |
| Fluoride | Active comparator | Application on Day 0, Day 180, Day 360, Day 540 Receives: Device: Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 360
Secondary outcomes (1)
Additional benefit of a second Curodont Repair application
The secondary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 360 to Day 720 between test and control group.
Measured: Day 720
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startJul 2014
- Primary completion26 Jun 2017
- Study completion26 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Credentis AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathias Seifert, Med. dent., Principal investigator, Zahnheilkunde Seifert Gmbh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101255
- Sponsor's protocol ID
- P11-4-RACL
- Status last verified
- Jul 2018
- First submitted
- 21 Mar 2014
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23969679
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Split-mouth, Post-marketing Study
- ClinicalTrials.gov ID
- NCT02101255
- Acronym / sponsor ID
- P11-4-RACL
- Conditions
- Dental Caries
- Keywords
- Dental caries, Curodont Repair, P11-4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Credentis AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 2 Apr 2014 (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 approximal carious lesions compared to fluoride.
Detailed description
All study participants must have two early approximal 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 fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curodont Repair | Experimental | Device: Curodont RepairApplication on Day 0 and Day 360 |
| Fluoride | Active comparator | Device: FluorideApplication on Day 0, Day 180, Day 360, Day 540 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Able and willing to observe good oral hygiene throughout the study
Key exclusion criteria (11 listed)
- 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)
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 Application on Day 0 and Day 360 | Device | Curodont Repair |
| FluorideAlso: DuraphatApplication on Day 0, Day 180, Day 360, Day 540 | Device | Fluoride |
Primary outcome
Opaqueness on X-Ray
Time frame: Day 360
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.
1 secondary outcome
Additional benefit of a second Curodont Repair application
Time frame: Day 720
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 18 Jul 2018.
- Background: PubMed 23969679Brunton 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.
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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.
Mathias Seifert, Med. dent. principal investigator
Zahnheilkunde Seifert Gmbh
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 11 inclusion and 11 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 18 Jul 2018. 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. 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?
Opaqueness on X-Ray (time frame: Day 360). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02101255, which also lists 1 linked publication.
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 18 Jul 2018.