NCT01529606

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

April 16, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

1.7 years

First QC Date

February 3, 2012

Results QC Date

February 28, 2020

Last Update Submit

April 6, 2020

Conditions

Dental RestorationCaries

Keywords

dental restorationdental cariestooth cavity

Outcome Measures

Primary Outcomes (3)

  • Number of Decayed, Missing and Filling Teeth (DMFT)

    Number of decayed, missing and filling teeth (DMFT) during 12 months

    12 months

  • Decayed and Filling Surfaces

    Number of decayed and filling surfaces

    12 months

  • Restoration Failure Rate

    Composite restoration evaluation for fracture or loss of filling partially or completely, with or without recurrent caries.

    12 months

Study Arms (2)

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.

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.

Procedure: Plasma treatment

Interventions

Composite restoration and tooth cleaningOTHER

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.

Also known as: Standard composite filling and preventive treatment
Standard care
Plasma treatmentPROCEDURE

plasma treatment after preparation and for caries prevention

Also known as: Plasma treatment and standard preventive treatment
Plasma treatment

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • untreated caries and at least one class II caries.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee Health Science

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Limitations and Caveats

No limitation is reported

Results Point of Contact

Title
Professor
Organization
UTHSC
lhong2@uthsc.edu
901-448-2369

Study Officials

  • Liang Hong, DDS, Ph.D

    The University of Tennessee Health Science Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Director

Study Record Dates

First Submitted

February 3, 2012

First Posted

February 9, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 16, 2020

Results First Posted

April 16, 2020

Record last verified: 2020-04

Locations

US(1)