Proximal CariesNCT04776785
Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries
A study testing Curodont™ Repair, MI Varnish™ and Profluorid® Varnish in people with Proximal Caries, run by Izmir Katip Celebi University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled, double-blinded, split-mouth clinical trial was to evaluate the efficacy of self-assembling peptide P11-4 solution (Curodont™ Repair) with fluoride varnish on the progression of non-cavitated proximal caries compared to casein phosphopeptide-amorphous calcium phosphate (CPP-ACP)… Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Proximal Caries
- What is being tested?
- Curodont™ Repair, MI Varnish™ and Profluorid® Varnish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 8 Jan 2021
- 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 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who had two permanent molars with non-cavitated proximal carious lesions that included one in the right jaw and the other one in the left jaw, and in contact with neighboring teeth,
- Non-cavitated proximal carious lesions which is radiographically extending into either the outer half of the enamel (E1), the inner half of the enamel (E2) or the outer third of the dentin (D1),
- Children who had not any systemic disease that prevents the application,
- Cooperative children who allowed to radiographic examinations and clinical applications.
Who cannot join
- There is caries/restoration on the different surface of the tooth to be treated,
- There is caries/restoration on the contact surface of the tooth adjacent to the tooth to be treated,
- Non-cavitated proximal carious lesions which is radiographically extending into the middle third of the dentin (D2) or the inner third of the dentin (D3),
- There is cavitation on the proximal surface of the tooth to be treated,
- Non-cooperative children who had not allow to radiographic examinations and clinical applications,
- Children and parents who denied the participation in the follow-up appointments.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Izmir Katip Celebi Uni.
Izmir
Izmir Katip Celebi University
Izmir
About this study
Official title: Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries: A Randomized Controlled Clinical Trial
The aim of this randomized controlled, double-blinded, split-mouth clinical trial was to evaluate the efficacy of self-assembling peptide P11-4 solution (Curodont™ Repair) with fluoride varnish on the progression of non-cavitated proximal caries compared to casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) with fluoride varnish (MI Varnish™) sodium fluoride (NaF) varnish (Profluorid® Varnish).
The study included 300 permanent molars belonging to 150 children, aged between 7 to 13 years old, who had two non-cavitated proximal carious lesions.
Read the detailed description
First, the subjects were randomly allocated to three main groups with 50 individuals in each. Then the carious lesions belonging to each subject were randomly assigned to two subgroups based on different treatment agents used: Group 1; P11-4+NaF/NaF, Group 2; P11-4+NaF/CPP-ACP+NaF, Group 3; CPP-ACP+NaF/NaF. Accordingly, test 1 lesions received P11-4+NaF combination, test 2 lesions received CPP-ACP+NaF varnish, and control lesions received NaF varnish alone. At the 6th and 12th months after the clinical applications, Profluorid® Varnish application was repeated for test 1 and control lesions, and MI Varnish™ application was repeated for test 2 lesions. At the end of the 12 months, carious lesion progression status was evaluated radiographically, by using independent visual reading, pair-wise visual reading, and digital subtraction radiography (DSR) methods.
- Conditions
- Proximal Caries
- Being tested
- Curodont™ Repair, MI Varnish™, Profluorid® Varnish
- Keywords
- Proximal caries, P11-4, CPP-ACFP, fluoride varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curodont™ RepairDevice
Also called CURODONT™ REPAIR, Credentis AG, Windisch, Switzerland
It is a product used in biomimetic remineralization of initial carious lesions. The product consists of "smart" P11-4 peptide molecules (CUROLOX® TECHNOLOGY) that within the lesion the molecules self-assemble to a 3D matrix. This bio-matrix enables the regeneration of the tooth tissue.
Test 1 lesions will be cleaned with a prophylaxis paste and isolated with cotton rolls. Then, the pellicle will be removed using 2% sodium hypochlorite (20 sec) and the inorganic deposits will be removed using 35% phosphoric acid (20 sec). The tooth surface will be rinsed with water and dried. Thereafter, Curodont™ Repair will be applied in compliance with the manufacturers' instructions and left for 5 minutes.
MI Varnish™Device
Also called MI Varnish™, GC America Inc., Alsip, IL, USA
MI Varnish™ is a 5% sodium fluoride (NaF) varnish that has a desensitizing action when applied to tooth surfaces. The product also contains RECALDENT™ (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. The application leaves a film of varnish on tooth surfaces and also facilitates the tooth remineralization.
Test 2 lesions will be isolated with cotton rolls. Then, MI Varnish ™ will be applied as a thin layer in equal thickness with a disposable brush in accordance with the manufacturers' instructions. Thereafter, the tooth surface will be moistened with water or saliva to ensure that the material adheres to the applied area.
Profluorid® VarnishDevice
Also called VOCO Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany
Profluorid® Varnish is a 5% sodium fluoride (NaF) varnish for surface application to enamel and dentin. The product will adhere to wet surfaces and is tolerant to moisture and saliva. Profluorid® Varnish is an ethanolic suspension of colophony with artificial flavors and sweetened with xylitol. It is also used in the remineralization of initial caries.
Control lesions will be isolated with cotton rolls. Then, Profluorid® Varnish will be applied as a thin layer in equal thickness with a disposable brush in accordance with the manufacturers' instructions. Thereafter, the tooth surface will be moistened with water or saliva to ensure that the material adheres to the applied area.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | In Group 1, one lesion will be received self-assembling peptide P11-4 solution (Curodont™ Repair, Credentis AG, Windisch, Switzerland) followed by 5% NaF varnish (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (test 1). The other lesion will be received 5% NaF varnish alone (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (control).
At the 6th and 12th months after the clinical applications, Profluorid® Varnish application will be repeated for test 1 and control lesions. Receives: Device: Curodont™ Repair; Device: Profluorid® Varnish |
| Group 2 | Experimental | In Group 2, one lesion will be received self-assembling peptide P11-4 solution (Curodont™ Repair, Credentis AG, Windisch, Switzerland) followed by 5% NaF varnish (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (test 1). The other lesion will be received CPP-ACP varnish containing 5% NaF (MI Varnish™, GC America Inc., Alsip, IL, USA) (test 2).
At the 6th and 12th months after the clinical applications; Profluorid® Varnish application will be repeated for test 1 lesions, and MI Varnish™ application will be repeated for test 2 lesions. Receives: Device: Curodont™ Repair; Device: MI Varnish™; Device: Profluorid® Varnish |
| Group 3 | Active comparator | In Group 3, one lesion will be received CPP-ACP varnish containing 5% NaF (MI Varnish™, GC America Inc., Alsip, IL, USA) (test 2). The other lesion will be received 5% NaF varnish alone (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (control).
At the 6th and 12th months after the clinical applications; MI Varnish™ application will be repeated for test 2 lesions, and Profluorid® Varnish application will be repeated for control lesions. Receives: Device: MI Varnish™; Device: Profluorid® Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of lesion progression by digital subtraction radiography (DSR)
The primary outcome of the study was assessment of lesion progression (change in the lesions' opacity) by DSR readings, at 12th month.
Measured: 12 months after the clinical applications
Secondary outcomes (2)
The assessment of lesion progression by pair-wise visual reading of radiographs
One of the secondary outcomes of the study was assessment of lesion progression (change in the lesions' opacity) assessed by pair-wise visual readings, at 12th month.
Measured: 12 months after the clinical applications
The assessment of lesion progression by independent visual reading of radiographs
The other one of the secondary outcomes of the study was assessment lesion progression (change in the classification of the lesions' size with respect to E0-E2, D1-D3 radiographic scoring system) assessed by independent visual readings, at 12th month.
Measured: 12 months after the clinical applications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Oct 2019
- Primary completion6 Dec 2020
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal 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
- Model description
- randomized controlled, three-arm parallel, double-blinded, split-mouth clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve AKCAY, Izmir Katip Celebi University
- Investigators
- Merve Akcay, assoc. prof., Study chair, Izmir Katip Celebi Uni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776785
- Sponsor's protocol ID
- 2019-TDU-DİŞF-0001
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04776785
- Acronym / sponsor ID
- 2019-TDU-DİŞF-0001
- Conditions
- Proximal Caries
- Keywords
- Proximal caries, P11-4, CPP-ACFP, fluoride varnish
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- 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 aim of this randomized controlled, double-blinded, split-mouth clinical trial was to evaluate the efficacy of self-assembling peptide P11-4 solution (Curodont™ Repair) with fluoride varnish on the progression of non-cavitated proximal caries compared to casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) with fluoride varnish (MI Varnish™) sodium fluoride (NaF) varnish (Profluorid® Varnish).
The study included 300 permanent molars belonging to 150 children, aged between 7 to 13 years old, who had two non-cavitated proximal carious lesions.
Detailed description
First, the subjects were randomly allocated to three main groups with 50 individuals in each. Then the carious lesions belonging to each subject were randomly assigned to two subgroups based on different treatment agents used: Group 1; P11-4+NaF/NaF, Group 2; P11-4+NaF/CPP-ACP+NaF, Group 3; CPP-ACP+NaF/NaF. Accordingly, test 1 lesions received P11-4+NaF combination, test 2 lesions received CPP-ACP+NaF varnish, and control lesions received NaF varnish alone. At the 6th and 12th months after the clinical applications, Profluorid® Varnish application was repeated for test 1 and control lesions, and MI Varnish™ application was repeated for test 2 lesions. At the end of the 12 months, carious lesion progression status was evaluated radiographically, by using independent visual reading, pair-wise visual reading, and digital subtraction radiography (DSR) methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled, three-arm parallel, double-blinded, split-mouth clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Curodont™ Repair, Device: Profluorid® VarnishIn Group 1, one lesion will be received self-assembling peptide P11-4 solution (Curodont™ Repair, Credentis AG, Windisch, Switzerland) followed by 5% NaF varnish (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (test 1). The other lesion will be received 5% NaF varnish alone (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (control). At the 6th and 12th months after the clinical applications, Profluorid® Varnish application will be repeated for test 1 and control lesions. |
| Group 2 | Experimental | Device: Curodont™ Repair, Device: MI Varnish™, Device: Profluorid® VarnishIn Group 2, one lesion will be received self-assembling peptide P11-4 solution (Curodont™ Repair, Credentis AG, Windisch, Switzerland) followed by 5% NaF varnish (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (test 1). The other lesion will be received CPP-ACP varnish containing 5% NaF (MI Varnish™, GC America Inc., Alsip, IL, USA) (test 2). At the 6th and 12th months after the clinical applications; Profluorid® Varnish application will be repeated for test 1 lesions, and MI Varnish™ application will be repeated for test 2 lesions. |
| Group 3 | Active comparator | Device: MI Varnish™, Device: Profluorid® VarnishIn Group 3, one lesion will be received CPP-ACP varnish containing 5% NaF (MI Varnish™, GC America Inc., Alsip, IL, USA) (test 2). The other lesion will be received 5% NaF varnish alone (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (control). At the 6th and 12th months after the clinical applications; MI Varnish™ application will be repeated for test 2 lesions, and Profluorid® Varnish application will be repeated for control lesions. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children who had two permanent molars with non-cavitated proximal carious lesions that included one in the right jaw and the other one in the left jaw, and in contact with neighboring teeth,
- Non-cavitated proximal carious lesions which is radiographically extending into either the outer half of the enamel (E1), the inner half of the enamel (E2) or the outer third of the dentin (D1),
- Children who had not any systemic disease that prevents the application,
- Cooperative children who allowed to radiographic examinations and clinical applications.
Key exclusion criteria (6 listed)
- There is caries/restoration on the different surface of the tooth to be treated,
- There is caries/restoration on the contact surface of the tooth adjacent to the tooth to be treated,
- Non-cavitated proximal carious lesions which is radiographically extending into the middle third of the dentin (D2) or the inner third of the dentin (D3),
- There is cavitation on the proximal surface of the tooth to be treated,
- Non-cooperative children who had not allow to radiographic examinations and clinical applications,
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: CURODONT™ REPAIR, Credentis AG, Windisch, SwitzerlandIt is a product used in biomimetic remineralization of initial carious lesions. The product consists of "smart" P11-4 peptide molecules (CUROLOX® TECHNOLOGY) that within the lesion the molecules self-assemble to a 3D matrix. This bio-matrix enables the regeneration of the tooth tissue. Test 1 lesions will be cleaned with a prophylaxis paste and isolated with cotton rolls. Then, the pellicle will be removed using 2% sodium hypochlorite (20 sec) and the inorganic deposits will be removed using 35% phosphoric acid (20 sec). The tooth surface will be rinsed with water and dried. Thereafter, Curodont™ Repair will be applied in compliance with the manufacturers' instructions and left for 5 minutes. | Device | Group 1, Group 2 |
| MI Varnish™Also: MI Varnish™, GC America Inc., Alsip, IL, USAMI Varnish™ is a 5% sodium fluoride (NaF) varnish that has a desensitizing action when applied to tooth surfaces. The product also contains RECALDENT™ (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. The application leaves a film of varnish on tooth surfaces and also facilitates the tooth remineralization. Test 2 lesions will be isolated with cotton rolls. Then, MI Varnish ™ will be applied as a thin layer in equal thickness with a disposable brush in accordance with the manufacturers' instructions. Thereafter, the tooth surface will be moistened with water or saliva to ensure that the material adheres to the applied area. | Device | Group 2, Group 3 |
| Profluorid® VarnishAlso: VOCO Profluorid® Varnish, VOCO GmbH, Cuxhaven, GermanyProfluorid® Varnish is a 5% sodium fluoride (NaF) varnish for surface application to enamel and dentin. The product will adhere to wet surfaces and is tolerant to moisture and saliva. Profluorid® Varnish is an ethanolic suspension of colophony with artificial flavors and sweetened with xylitol. It is also used in the remineralization of initial caries. Control lesions will be isolated with cotton rolls. Then, Profluorid® Varnish will be applied as a thin layer in equal thickness with a disposable brush in accordance with the manufacturers' instructions. Thereafter, the tooth surface will be moistened with water or saliva to ensure that the material adheres to the applied area. | Device | Group 1, Group 2, Group 3 |
Primary outcome
The assessment of lesion progression by digital subtraction radiography (DSR)
Time frame: 12 months after the clinical applications
The primary outcome of the study was assessment of lesion progression (change in the lesions' opacity) by DSR readings, at 12th month.
2 secondary outcomes
The assessment of lesion progression by pair-wise visual reading of radiographs
Time frame: 12 months after the clinical applications
The assessment of lesion progression by independent visual reading of radiographs
Time frame: 12 months after the clinical applications
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 12 Mar 2021.
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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.
Merve Akcay, assoc. prof. study chair
Izmir Katip Celebi Uni
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curodont™ Repair, MI Varnish™ and Profluorid® Varnish in people with Proximal Caries, run by Izmir Katip Celebi University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 6 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 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The assessment of lesion progression by digital subtraction radiography (DSR) (time frame: 12 months after the clinical applications). 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 12 Mar 2021.