Cold Plasma for Dental Restoration and Caries Prevention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01529606|
Recruitment Status : Completed
First Posted : February 9, 2012
Results First Posted : April 16, 2020
Last Update Posted : April 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dental Restoration Caries||Other: Composite restoration and tooth cleaning Procedure: Plasma treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of a Miniature Plasma Brush for Dental Clinical Applications|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529606
|United States, Tennessee|
|University of Tennessee Health Science|
|Memphis, Tennessee, United States, 38163|
|Principal Investigator:||Liang Hong, DDS, Ph.D||The University of Tennessee Health Science Center|