Cervical CariesNCT03501784
Nobio Antimicrobial Particles Effect in a Split Mouth Model
A study testing Nobio particles incorporated within Novidia Dental Bonding and Filtek bond and flow composite in people with Cervical Caries, run by Nobio Ltd. at 1 site in Israel.
Trial summary
The study purpose is to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable Composite versus standard of care within a split mouth model.The study population will include 35 subjects considered to be at high risk for cervical caries and affected by uncontrolled… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Caries
- What is being tested?
- Nobio particles incorporated within Novidia Dental Bonding and Filtek bond and flow composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Sep 2018to 30 Dec 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over 18 years of age.
- Requires two cervical restorations or the exchange of existing ones
- Subject has poor oral hygiene and at high risk for plaque accumulation.
- Subject able and willing to comply with study visits and Follow up visits and signed the informed consent.
Who cannot join
- Allergic reaction to iodide.
- Pregnant or lactating women.
- Use of antiseptic mouth rinse or antibiotic up to 2 weeks before the beginning of study.
- Tooth designated for extraction in the following 6 month.
- Tooth designated to have a root canal treatment.
- Tooth or several teeth designated for periodontal surgery.
Trial locations and contacts
1 site in 1 country.
Bertrude LEV DOR, DMD contact
Israel1 site, 1 recruiting
- Recruiting
Assuta Medical Center -Maccabident
Tel Aviv, 5242321
Bertrude Lev- Dor, DMD, 03-03-764-4444, levdor_b@maccabi-dent.com
About this study
The study purpose is to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable Composite versus standard of care within a split mouth model.The study population will include 35 subjects considered to be at high risk for cervical caries and affected by uncontrolled plaque accumulation
Read the detailed description
An exploratory, comparative, self-controlled single blinded interventional study. Intended to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable composite versus Filtek bond and flow composite within a split mouth model.The study population (N=35) will be high risk population for cervical caries (with at least 2 carious cavities in the mouth) affected by uncontrolled plaque accumulation.Each subject will serve in this model as his own control.On one side the Novidia intervention will be made and on the contralateral side the Filtek intervention.
- Conditions
- Cervical Caries
- Being tested
- Nobio particles incorporated within Novidia Dental Bonding, Filtek bond and flow composite
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nobio particles incorporated within Novidia Dental BondingDevice
Also called Device
Nobio particles incorporated within Novidia Dental Bonding and Flow
Filtek bond and flow compositeDevice
standard of care class V composite restoration performed with Filtek and 3M
| Study group | Role | What they receive |
|---|---|---|
| Novidia Dental bonding and flow | Experimental | Nobio particles incorporated within Novidia Dental Bonding and Flow. Receives: Device: Nobio particles incorporated within Novidia Dental Bonding |
| Filtek bond and flow composite | Active comparator | standard of care class V composite restoration performed with Filtek and 3M Receives: Device: Filtek bond and flow composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and severity of adverse events related to dental care
Record unanticipated adverse device-related events (UADE),Incidence and nature of serious adverse events (SAE).
Incidence and nature of adverse events
Measured: one year
Secondary outcomes (5)
Plaque index rate
0 -No Plaque up to 3-Abundance plaque
Measured: one year
Replica method for bacterial count
Impression matrix sampling the tooth bio film layer
Measured: one year
Physician assessment of cervical restoration integrity
Marginal integrity of the performed restoration
Measured: one year
Subject and Dentist satisfaction questionnaire
satisfaction questionnaire ranging from 1(strongly disagree )to 10 (strongly agree)
Measured: one year
Dead/Live Staining of biofilm (Cyto 9)
CSLM quantitative measurement
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start22 Sep 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is an exploratory, comparative, self-controlled, single blind study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nobio Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bertrude LEV DOR, DMD, Principal investigator, MACCABIDENT ASSUTABat sheva Levy, Study director, Nobio Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501784
- Sponsor's protocol ID
- ND01 version 02
- Status last verified
- Aug 2018
- First submitted
- 6 Mar 2018
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The final study results will be shared
Publications
Atar-Froyman L, Sharon A, Weiss EI, Houri-Haddad Y, Kesler-Shvero D, Domb AJ, Pilo R, Beyth N. Anti-biofilm properties of wound dressing incorporating nonrelease polycationic antimicrobials. Biomaterials. 2015 Apr;46:141-8. doi: 10.1016/j.biomaterials.2014.12.047. Epub 2015 Jan 28.
PubMed 25678123Beyth N, Yudovin-Farber I, Perez-Davidi M, Domb AJ, Weiss EI. Polyethyleneimine nanoparticles incorporated into resin composite cause cell death and trigger biofilm stress in vivo. Proc Natl Acad Sci U S A. 2010 Dec 21;107(51):22038-43. doi: 10.1073/pnas.1010341107. Epub 2010 Dec 3.
PubMed 21131569
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nobio Antimicrobial Particles Effect in a Split Mouth Model
- ClinicalTrials.gov ID
- NCT03501784
- Acronym / sponsor ID
- ND01 version 02
- Conditions
- Cervical Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Nobio Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 18 Apr 2018 (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 study purpose is to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable Composite versus standard of care within a split mouth model.The study population will include 35 subjects considered to be at high risk for cervical caries and affected by uncontrolled plaque accumulation
Detailed description
An exploratory, comparative, self-controlled single blinded interventional study. Intended to evaluate the antimicrobial effect of Nobio particles incorporated within Novidia Dental Bonding and Flowable composite versus Filtek bond and flow composite within a split mouth model.The study population (N=35) will be high risk population for cervical caries (with at least 2 carious cavities in the mouth) affected by uncontrolled plaque accumulation.Each subject will serve in this model as his own control.On one side the Novidia intervention will be made and on the contralateral side the Filtek intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is an exploratory, comparative, self-controlled, single blind study
| Arm | Type | Receives |
|---|---|---|
| Novidia Dental bonding and flow | Experimental | Device: Nobio particles incorporated within Novidia Dental BondingNobio particles incorporated within Novidia Dental Bonding and Flow. |
| Filtek bond and flow composite | Active comparator | Device: Filtek bond and flow compositestandard of care class V composite restoration performed with Filtek and 3M |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female over 18 years of age.
- Requires two cervical restorations or the exchange of existing ones
- Subject has poor oral hygiene and at high risk for plaque accumulation.
- Subject able and willing to comply with study visits and Follow up visits and signed the informed consent.
Key exclusion criteria (6 listed)
- Allergic reaction to iodide.
- Pregnant or lactating women.
- Use of antiseptic mouth rinse or antibiotic up to 2 weeks before the beginning of study.
- Tooth designated for extraction in the following 6 month.
- Tooth designated to have a root canal treatment.
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 |
|---|---|---|
| Nobio particles incorporated within Novidia Dental BondingAlso: DeviceNobio particles incorporated within Novidia Dental Bonding and Flow | Device | Novidia Dental bonding and flow |
| Filtek bond and flow compositestandard of care class V composite restoration performed with Filtek and 3M | Device | Filtek bond and flow composite |
Primary outcome
Occurrence and severity of adverse events related to dental care
Time frame: one year
Record unanticipated adverse device-related events (UADE),Incidence and nature of serious adverse events (SAE). Incidence and nature of adverse events
5 secondary outcomes
Plaque index rate
Time frame: one year
Replica method for bacterial count
Time frame: one year
Physician assessment of cervical restoration integrity
Time frame: one year
Subject and Dentist satisfaction questionnaire
Time frame: one year
Dead/Live Staining of biofilm (Cyto 9)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Background: PubMed 25678123Atar-Froyman L, Sharon A, Weiss EI, Houri-Haddad Y, Kesler-Shvero D, Domb AJ, Pilo R, Beyth N. Anti-biofilm properties of wound dressing incorporating nonrelease polycationic antimicrobials. Biomaterials. 2015 Apr;46:141-8. doi: 10.1016/j.biomaterials.2014.12.047. Epub 2015 Jan 28.
- Results publication: PubMed 21131569Beyth N, Yudovin-Farber I, Perez-Davidi M, Domb AJ, Weiss EI. Polyethyleneimine nanoparticles incorporated into resin composite cause cell death and trigger biofilm stress in vivo. Proc Natl Acad Sci U S A. 2010 Dec 21;107(51):22038-43. doi: 10.1073/pnas.1010341107. Epub 2010 Dec 3.
- Individual participant dataSharing planned: No. The final study results will be shared
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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.
Bertrude LEV DOR, DMD contact
Bertrude LEV DOR, DMD principal investigator
MACCABIDENT ASSUTA
Bat sheva Levy study director
Nobio Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nobio particles incorporated within Novidia Dental Bonding and Filtek bond and flow composite in people with Cervical Caries, run by Nobio Ltd. at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 18 Mar 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertrude LEV DOR, DMD (972-54-772-0015, levdor_b@maccabi-dent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence and severity of adverse events related to dental care (time frame: one year). 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 NCT03501784, which also lists 2 linked publications.
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 Mar 2019; AzTrials last refreshed its copy on 29 Oct 2026.