Erosion of Teeth, UnspecifiedNCT02308436
Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide
A study testing Candida Mouthwash with Curolox™ Peptide in people with Erosion of Teeth, Unspecified, run by Mibelle AG at 1 site in Switzerland.
Trial summary
In vitro results showed a protective effect against acids for the mouthwash containing Curolox™ peptide. The goal of this in situ study is to detect the Curolox™ peptide under natural oral conditions on the tooth surface and to proof the in vitro results obtained. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Erosion of Teeth, Unspecified
- What is being tested?
- Candida Mouthwash with Curolox™ Peptide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to Mar 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to understand and to follow the study procedures and instructions
- Willing to wear a dental appliance for 7 days
- Willing and able to attend the on-study visits
- Good oral hygiene throughout the study
- Written informed consent before participation in the study
Who cannot join
- Volunteer with an active periodontal disease or periodontal surgery < 1 year prior to study participation
- Volunteer with hypersensitive teeth or with any other (painful) oral pathology or defect
- Volunteer with an orthodontic appliance
- Volunteer undergoing a medical treatment
- Volunteer who is allergic to dental products
- Pregnant and lactating woman
- Concurrent participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide: a Mono-centre, Not-controlled. Not Blinded, Not-randmised in Situ Study
In vitro results showed a protective effect against acids for the mouthwash containing Curolox™ peptide. The goal of this in situ study is to detect the Curolox™ peptide under natural oral conditions on the tooth surface and to proof the in vitro results obtained. So far there are no effect and safety data of the Curolox™ mouthwash under natural oral conditions available.
Read the detailed description
The primary objective of the study is the detection of the Curolox™ peptide on the bovine enamel sample (proof-of-concept) under in vivo conditions after rinsing with the peptide-containing mouth wash.
Secondary Objectives
The secondary objectives of the study are:
- safety and tolerance of the mouthwash in participants
- identification of the duration the Curolox™ peptide is present on the bovine tooth surface under in vivo conditions
- identification of the most effective mouthwash rinsing volume (2.5 mL or 5 mL)
- prophylactic effect of multiple applications of the mouthwash confirmation of the prophylactic effect of the Curolox™ peptide obtained in in vitro study
- Conditions
- Erosion of Teeth, Unspecified
- Being tested
- Candida Mouthwash with Curolox™ Peptide
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candida Mouthwash with Curolox™ PeptideDevice
Also called Candida Protect
Prophylaxis - protection and care of teeth against caries \& acidic challenges
| Study group | Role | What they receive |
|---|---|---|
| Candida Mouthwash with Curolox™ Peptide | Experimental | Repeated applications 2.5 ml or 5 ml twice daily Receives: Device: Candida Mouthwash with Curolox™ Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Curolox peptide by mass spectroscopy
The primary outcome is the detection of the Curolox™ peptide on the bovine enamel sample immediately after rinsing with the peptide-containing mouth wash by mass spectroscopy
Measured: Immediately after rinsing with the mouthwash
Secondary outcomes (1)
Detection of Curolox peptide by mass spectroscopy
The secondary outcome is the detection of the Curolox™ peptide on the bovine enamel sample 12 hours, 24 hours, 48 hours and 96 hours after rinsing with the peptide-containing mouth wash by mass spectroscopy
Measured: 12 hours, 24 hours, 48 hours, 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Why it stopped: Study is not realised.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosion of Teeth, UnspecifiedStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mibelle AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Besimo, Dr.med.dent., Principal investigator, Aeskulap KlinikUlrich P. Saxer, Dr.med.dent., Study director, Aeskulap Klinik / PZZN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308436
- Sponsor's protocol ID
- P11-4-MW15.042
- Status last verified
- Aug 2015
- First submitted
- 27 Nov 2014
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide: a Mono-centre, Not-controlled. Not Blinded, Not-randmised in Situ Study
- ClinicalTrials.gov ID
- NCT02308436
- Acronym / sponsor ID
- P11-4-MW15.042
- Conditions
- Erosion of Teeth, Unspecified
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is not realised.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mibelle AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 4 Dec 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.
In vitro results showed a protective effect against acids for the mouthwash containing Curolox™ peptide. The goal of this in situ study is to detect the Curolox™ peptide under natural oral conditions on the tooth surface and to proof the in vitro results obtained. So far there are no effect and safety data of the Curolox™ mouthwash under natural oral conditions available.
Detailed description
The primary objective of the study is the detection of the Curolox™ peptide on the bovine enamel sample (proof-of-concept) under in vivo conditions after rinsing with the peptide-containing mouth wash.
Secondary Objectives
The secondary objectives of the study are:
- safety and tolerance of the mouthwash in participants
- identification of the duration the Curolox™ peptide is present on the bovine tooth surface under in vivo conditions
- identification of the most effective mouthwash rinsing volume (2.5 mL or 5 mL)
- prophylactic effect of multiple applications of the mouthwash confirmation of the prophylactic effect of the Curolox™ peptide obtained in in vitro study
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candida Mouthwash with Curolox™ Peptide | Experimental | Device: Candida Mouthwash with Curolox™ PeptideRepeated applications 2.5 ml or 5 ml twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to understand and to follow the study procedures and instructions
- Willing to wear a dental appliance for 7 days
- Willing and able to attend the on-study visits
- Good oral hygiene throughout the study
- Written informed consent before participation in the study
Key exclusion criteria (7 listed)
- Volunteer with an active periodontal disease or periodontal surgery < 1 year prior to study participation
- Volunteer with hypersensitive teeth or with any other (painful) oral pathology or defect
- Volunteer with an orthodontic appliance
- Volunteer undergoing a medical treatment
- Volunteer who is allergic to dental products
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 |
|---|---|---|
| Candida Mouthwash with Curolox™ PeptideAlso: Candida ProtectProphylaxis - protection and care of teeth against caries \& acidic challenges | Device | Candida Mouthwash with Curolox™ Peptide |
Primary outcome
Detection of Curolox peptide by mass spectroscopy
Time frame: Immediately after rinsing with the mouthwash
The primary outcome is the detection of the Curolox™ peptide on the bovine enamel sample immediately after rinsing with the peptide-containing mouth wash by mass spectroscopy
1 secondary outcome
Detection of Curolox peptide by mass spectroscopy
Time frame: 12 hours, 24 hours, 48 hours, 96 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2015.
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.
Christian Besimo, Dr.med.dent. principal investigator
Aeskulap Klinik
Ulrich P. Saxer, Dr.med.dent. study director
Aeskulap Klinik / PZZN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Candida Mouthwash with Curolox™ Peptide in people with Erosion of Teeth, Unspecified, run by Mibelle 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 28 Aug 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Detection of Curolox peptide by mass spectroscopy (time frame: Immediately after rinsing with the mouthwash). 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 28 Aug 2015.