Cold Plasma for Dental Restoration and Caries Prevention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Nanova, Inc.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Liang Hong, University of Tennessee
ClinicalTrials.gov Identifier:
NCT01529606
First received: February 3, 2012
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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 that of the standard care in dentistry for treating dental cavities, and effects on caries prevention.


Condition Intervention Phase
Dental Restoration
Caries
Other: Composite restoration and tooth cleaning
Procedure: Plasma treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development of a Miniature Plasma Brush for Dental Clinical Applications

Resource links provided by NLM:


Further study details as provided by Nanova, Inc:

Primary Outcome Measures:
  • caries development [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • restoration failure rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard care
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.
Other: Composite restoration and tooth cleaning
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.
Other Name: Standard composite filling and preventive treatment
Experimental: Plasma treatment
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.
Procedure: Plasma treatment
plasma treatment after preparation and for caries prevention
Other Name: Plasma treatment and standard preventive treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529606

Contacts
Contact: Liang Hong 901-457-2369 lhong2@uthsc.edu

Locations
United States, Tennessee
University of Tennessee Health Science Not yet recruiting
Memphis, Tennessee, United States, 38163
Contact: Liang Hong    901-448-2369    lhong2@uthsc.edu   
Sponsors and Collaborators
Nanova, Inc
Investigators
Principal Investigator: Liang Hong, DDS, Ph.D The University of Tennessee Health Science Center
  More Information

No publications provided

Responsible Party: Liang Hong, Associate Professor and Director, University of Tennessee
ClinicalTrials.gov Identifier: NCT01529606     History of Changes
Other Study ID Numbers: 5R44DE019041, 5R44DE019041
Study First Received: February 3, 2012
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Nanova, Inc:
dental restoration
dental caries
tooth cavity

ClinicalTrials.gov processed this record on April 15, 2014