Dental RestorationNCT01529606

Cold Plasma for Dental Restoration and Caries Prevention

A study testing Composite restoration and tooth cleaning and Plasma treatment in people with Dental Restoration and Caries, run by Nanova, Inc at 1 site in United States.

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

The main objective of this entire research project is to develop a miniature atmospheric cold plasma brush (m-ACPB) for dental clinical applications. The objective of the clinical trial portion of the study is to compare the longevity and durability of dental composite restorations created using the plasma brush, to… Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Dental Restoration, Caries
What is being tested?: Composite restoration and tooth cleaning and Plasma treatment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteUnited States
Study dates: Sep 2012to Jun 2014
Phase: Interventional
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 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

subject must be Caucasian or Africa American, 18-35 years old, have written, completed, informed consent forms;
be generally healthy;
be able to participate in the study;
have no diagnosed periodontitis and pericoronitis;
have no active mucosal diseases such as aphthous ulcers and herpetic stomatitis.
They must also agree to follow study instructions.
The patients must meet the following specific entry criteria:
1-5 untreated caries and at least one class II caries.

Who cannot join

each subject must have no diagnosed diabetes mellitus or any other endocrine diseases;
no diagnosed cardiovascular diseases;
no diagnosed immune-compromised diseases, such as HIV and AIDS;
no other serious systemic diseases, such as cancer;
no antibiotic therapy in the past 6 months;
no use of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 3 months; and
no reported use of illicit drugs.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Tennessee Health Science
Memphis, Tennessee, 38163

Other trials in United States

About this study

Official title: Development of a Miniature Plasma Brush for Dental Clinical Applications

Read the detailed description

The study will be a randomized controlled trial (RCT) and be approved by the institute review board of the University of Tennessee Health Science Center. The study subjects will be composed of young adults 18-35 years old in order to control effects of age on caries. Also the subjects must be Caucasian or Africa American. Young adult patients will be recruited from the UTHSC dental clinics.The baseline visit include a dental exam by one of the investigators, standard preventive dental care (e.g cleaning, application of fluoride varnish), anthropometric measurements, oral health interview survey. 100 patients who meet all inclusion and exclusion criteria will be recruited after they sign an informed consent form. These patients will be randomly assigned to 1 of 2 study groups. Randomization assignment will be stratified by age and number of teeth with caries. Two study groups will be: 1.) plasma treatment group and 2) standard treatment group. For patients in standard treatment group, they will receive composite resin restoration for all decayed teeth and standard preventive treatment (cleaning and fluoride varnish application) at baseline. For patients in plasma treatment group, they will receive plasma treatment after cavity preparation, composite resin restoration, standard preventive treatment followed by plasma treatment for non-carious teeth. Standard preventive treatment and plasma treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction. Only one composite commercially available will be used during the study.

Conditions: Dental Restoration, Caries
Being tested: Composite restoration and tooth cleaning, Plasma treatment
Keywords: dental restoration, dental caries, tooth cavity
Medical subject headings: Dental Caries

What participants receive

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

Composite restoration and tooth cleaningOther
Also called Standard composite filling and preventive treatment
Standard preventive treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction.
Plasma treatmentProcedure or surgery
Also called Plasma treatment and standard preventive treatment
plasma treatment after preparation and for caries prevention

Study groups in NCT01529606
Study group	Role	What they receive
Standard care	Active comparator	Fifty patients will be recruited into standard treatment group and they will receive composite resin restoration for all decayed teeth and standard preventive treatment (cleaning and fluoride varnish application) at baseline. Receives: Other: Composite restoration and tooth cleaning
Plasma treatment	Experimental	Fifty patients will be recruited into plasma treatment group and they will receive plasma treatment after cavity preparation, composite resin restoration, standard preventive treatment followed by plasma treatment for non-carious teeth. Receives: Procedure: Plasma treatment

What is being measured

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

Number of Decayed, Missing and Filling Teeth (DMFT)
Number of decayed, missing and filling teeth (DMFT) during 12 months
Measured: 12 months
Decayed and Filling Surfaces
Number of decayed and filling surfaces
Measured: 12 months
Restoration Failure Rate
Composite restoration evaluation for fracture or loss of filling partially or completely, with or without recurrent caries.
Measured: 12 months

Timeline

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

Sep 2012Jun 2014

First posted9 Feb 2012 (estimated)
Study startSep 2012
Primary completionJun 2014
Study completionJun 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.
Other trials for Dental RestorationStudies 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: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01529606
Sponsor's protocol ID: 5R44DE019041
Other IDs: 5R44DE019041
Status last verified: Apr 2020
First submitted: 3 Feb 2012
Last updated: 16 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

See locations

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All Dental Restoration trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of a Miniature Plasma Brush for Dental Clinical Applications
ClinicalTrials.gov ID: NCT01529606
Acronym / sponsor ID: 5R44DE019041
Conditions: Dental Restoration, Caries
Keywords: dental restoration, dental caries, tooth cavity
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Nanova, IncIndustry (pharma, biotech, devices)
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
Study start: Sep 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 9 Feb 2012 (estimated)
Results: Posted 16 Apr 2020

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: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard care	Active comparator	Other: Composite restoration and tooth cleaningFifty patients will be recruited into standard treatment group and they will receive composite resin restoration for all decayed teeth and standard preventive treatment (cleaning and fluoride varnish application) at baseline.
Plasma treatment	Experimental	Procedure: Plasma treatmentFifty patients will be recruited into plasma treatment group and they will receive plasma treatment after cavity preparation, composite resin restoration, standard preventive treatment followed by plasma treatment for non-carious teeth.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

subject must be Caucasian or Africa American, 18-35 years old, have written, completed, informed consent forms;
be generally healthy;
be able to participate in the study;
have no diagnosed periodontitis and pericoronitis;
have no active mucosal diseases such as aphthous ulcers and herpetic stomatitis.

Key exclusion criteria (7 listed)

each subject must have no diagnosed diabetes mellitus or any other endocrine diseases;
no diagnosed cardiovascular diseases;
no diagnosed immune-compromised diseases, such as HIV and AIDS;
no other serious systemic diseases, such as cancer;
no antibiotic therapy in the past 6 months;

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
Composite restoration and tooth cleaningAlso: Standard composite filling and preventive treatmentStandard preventive treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction.	Other	Standard care
Plasma treatmentAlso: Plasma treatment and standard preventive treatmentplasma treatment after preparation and for caries prevention	Procedure or surgery	Plasma treatment

Primary outcome

Number of Decayed, Missing and Filling Teeth (DMFT)
Time frame: 12 months
Number of decayed, missing and filling teeth (DMFT) during 12 months
Decayed and Filling Surfaces
Time frame: 12 months
Number of decayed and filling surfaces
Restoration Failure Rate
Time frame: 12 months
Composite restoration evaluation for fracture or loss of filling partially or completely, with or without recurrent caries.

Results and safety

Results posted to the registry on 16 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Care	55	34
Plasma Treatment	47	29

Primary outcome: Number of Decayed, Missing and Filling Teeth (DMFT)

Time frame: 12 months. Mean (Standard Deviation). Unit: teeth

Measure	Standard Care n = 34	Plasma Treatment n = 29
Value	6.29 (4.07)	5.14 (4.70)

Population analysed: 34 participants in standard care group and 29 in plasma group

Primary outcome: Decayed and Filling Surfaces

Time frame: 12 months. Mean (Standard Deviation). Unit: tooth surface

Measure	Standard Care n = 34	Plasma Treatment n = 29
Value	9.03 (8.14)	7.72 (8.16)

Primary outcome: Restoration Failure Rate

Time frame: 12 months. Number. Unit: composite fillings

Measure	Standard Care n = 27	Plasma Treatment n = 21
Value	2	0

Population analysed: After 12 months, in standard care group, we had 27 participants remaining and lost 28 participants; in plasma treatment group, we had 21 participants remaining and lost 26 participants. Units of analysis for composite restoration failure is number of composite restorations in each group. A participant may have more than one composite restoration.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Care	0 of 55 (0%)	0 of 55 (0%)	0 of 55
Plasma Treatment	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Limitations and caveats (from the sponsor): No limitation is reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Liang Hong, DDS, Ph.D principal investigator

The University of Tennessee Health Science Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Composite restoration and tooth cleaning and Plasma treatment in people with Dental Restoration and Caries, run by Nanova, Inc at 1 site in United States.

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 8 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: finished, as of the sponsor's last update on 16 Apr 2020. 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 United States. 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?

Yes. Results are posted in the registry (first posted 16 Apr 2020). 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?

Number of Decayed, Missing and Filling Teeth (DMFT) (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT01529606.

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 16 Apr 2020.