Dental CariesPhase 1/2NCT02724592

Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions

A Phase 1/2 study testing self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) in people with Dental Caries, run by University Medicine Greifswald.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 years and olderHealthy volunteers can take part
Conditions the study is for: Dental Caries
What is being tested?: self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: No sites listed yet
Study dates: Feb 2013to Oct 2014
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 5 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Early occlusal carious lesions (without cavity) on permanent molar "6" or "7" at eruption which does not require an invasive treatment
Age ≥ 5 years
Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
Written informed consent before participation in the study

Who cannot join

Evidence of tooth erosion
Fluoride varnish application < 3 months prior to study treatment
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
Concurrent participation in another clinical trial

About this study

Official title: Effect of Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised Study

Objectives: Occlusal surfaces of erupting permanent molars are highly prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.

Read the detailed description

Objectives: Occlusal surfaces of erupting permanent molars are high prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.

Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups. Safety and applicability will be evaluated using dentist's/patient's questionnaires about adverse events, difficulties of application and satisfaction with procedure. Lesions will be assessed at baseline and recalls after 3 and 6 months regarding caries activity, clinical status (ICDAS-II) and with Diagnodent®. The Visual Analog Scale (VAS) of regression and of lesion size in addition to the Global Impression of Change Questionnaire will also be assessed. At every recall, fluoride varnish will be applied on lesions and patients received oral health instructions.

Conditions: Dental Caries
Being tested: self assembling peptide P11-4 (Curodont™ Repair), fluoride varnish (Duraphat®)
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

self assembling peptide P11-4 (Curodont™ Repair)Device
Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions
fluoride varnish (Duraphat®)Device
Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions

Study groups in NCT02724592
Study group	Role	What they receive
intervention	Experimental	intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) Receives: Device: self assembling peptide P11-4 (Curodont™ Repair); Device: fluoride varnish (Duraphat®)
control	Active comparator	control group, only Fluoride varnish (Duraphat®) Receives: Device: fluoride varnish (Duraphat®)

What is being measured

The primary outcome is the main question the study is designed to answer.

Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device.
Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using LASER "Light Amplification by Stimulated Emission of Radiation" fluorescence readings by Diagnodent® device.
Diagnodent® device measures the caries activity using LASER fluorescence of bacterial secretions in the caries lesion. The readings range from 0 to 99; 0 means no bacterial activity in the carious lesion whereas 99 refers to high bacterial and caries activity.
Effect via the changes in LASER fluorescence readings between Baseline and 6-months recall (Change = Baseline value - 6 months value). Higher positive change value means caries regression, whereas lower positive or negative change value refers to caries progression.
Measured: 6 months

Secondary outcomes (3)

Visual Analog Scale of Lesion Progression (VAS)
Visual Analog Scale of lesion progression (VAS), Effect via t test between Baseline and 6-months recall VAS values range from -100 % to +100 %. The value of -100 means that the carious lesion is strongly remineralising, the value of 0 means that the lesion is arrested, and the value of +100 means that the lesion is strongly progressing.
Measured: 6 months
ICDAS Classification Index
Number of patients who have improvement on the ICDAS classification index (International Caries Detection and Assessment System), changes from Baseline to 6-months recall.
This carries clinical index range from 0 to 6. The values mean:
0 No evidence of caries
1. Initial caries
2. Distinct visual change in enamel
3. Localised enamel breakdown due to caries with no visible dentine
4. Underlying dark shadow from dentine
5. Distinct cavity with visible dentine
6. Extensive distinct cavity with visible dentine. During the study, a change from level to lower level number (e.g. from 2 to 1) in patients means that the carious lesion is regressed.
Measured: 6 months
Caries Activity Assessment According to Nyvad Criteria
Caries activity assessment according to Nyvad criteria, number of participants still have active lesions overall study.
This assessment includes two clinical judgment inserts: active lesion or inactive lesion basing on visual-tactile surface characteristics of the caries lesions such as integrity, texture, translucency/opacity, lesion location, and surface color.
During the study, an alteration from active lesion to in active lesion means an improvement.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Oct 2014

First posted31 Mar 2016 (estimated)
Study startFeb 2013
Primary completionApr 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02724592
Sponsor's protocol ID: BB001/13
Status last verified: Mar 2021
First submitted: 7 Mar 2016
Last updated: 8 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Alkilzy M, Tarabaih A, Santamaria RM, Splieth CH. Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel. J Dent Res. 2018 Feb;97(2):148-154. doi: 10.1177/0022034517730531. Epub 2017 Sep 11.
PubMed 28892645

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised Study
ClinicalTrials.gov ID: NCT02724592
Acronym / sponsor ID: BB001/13
Conditions: Dental Caries
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: University Medicine GreifswaldUniversity, hospital or other
Study start: Feb 2013
Primary completion: Apr 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 31 Mar 2016 (estimated)
Results: Posted 8 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
intervention	Experimental	Device: self assembling peptide P11-4 (Curodont™ Repair), Device: fluoride varnish (Duraphat®)intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)
control	Active comparator	Device: fluoride varnish (Duraphat®)control group, only Fluoride varnish (Duraphat®)

Who may qualify

Ages: 5 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Early occlusal carious lesions (without cavity) on permanent molar "6" or "7" at eruption which does not require an invasive treatment
Age ≥ 5 years
Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
Written informed consent before participation in the study

Key exclusion criteria (6 listed)

Evidence of tooth erosion
Fluoride varnish application < 3 months prior to study treatment
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

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
self assembling peptide P11-4 (Curodont™ Repair)Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions	Device	intervention
fluoride varnish (Duraphat®)Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions	Device	control, intervention

Primary outcome

Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device.
Time frame: 6 months
Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using LASER "Light Amplification by Stimulated Emission of Radiation" fluorescence readings by Diagnodent® device. Diagnodent® device measures the caries activity using LASER fluorescence of bacterial secretions in the caries lesion. The readings range from 0 to 99; 0 means no bacterial activity in the carious lesion whereas 99 refers to high bacterial and caries activity. Effect via the changes in LASER fluorescence readings between Baseline and 6-months recall (Change = Baseline value - 6 months value). Higher positive change value means caries regression, whereas lower positive or negative change value refers to caries progression.

3 secondary outcomes

Visual Analog Scale of Lesion Progression (VAS)
Time frame: 6 months
ICDAS Classification Index
Time frame: 6 months
Caries Activity Assessment According to Nyvad Criteria
Time frame: 6 months

Results and safety

Results posted to the registry on 8 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	35	31
Control	35	34

Primary outcome: Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device.

Time frame: 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Intervention n = 31	Control n = 34
Value	18.6 (19.8)	1.1 (25.8)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Control	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28892645Alkilzy M, Tarabaih A, Santamaria RM, Splieth CH. Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel. J Dent Res. 2018 Feb;97(2):148-154. doi: 10.1177/0022034517730531. Epub 2017 Sep 11.
Individual participant dataSharing planned: No

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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.

Mohammad Alkilzy, Dr. PhD principal investigator

University of Greifswald

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) in people with Dental Caries, run by University Medicine Greifswald.

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 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device. (time frame: 6 months). 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 NCT02724592, 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 8 Apr 2021.