Clinical Studies Division

Amy Nuñez, BSDH, CCRP

Director, Clinical Studies

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(317) 565-8079

Clinical Studies is a subdivision of Dental Product Testing (DPT) at Therametric Technologies. Our Clinical Studies team assists Sponsors in testing and verifying the efficacy and safety of their products/devices through human clinical trials.  Principal Investigator:  Dr. George Stookey, Ph.D.  will help to design and develop a customized protocol for prospective clients and Amy Nunez, BSDH, CCRP, directs the operations of the studies.  At TTI, our clinical trials are offered in product & new methodology development, safety, efficacy, claims substantiation, comparison and ADA/FDA guideline studies.  We offer both in-Vivo and in-Situ study designs for a variety of different testing models. All studies are conducted with trained and qualified clinical examiners and are conducted in compliance  with the Belmont Report, Good Clinical Practice (GCP/ICH), Code of Federal Regulations, FDA information Sheets, and are overseen by an Institutional Review Board as required by federal law.  

dental clinical trials, in-situ, dental appliance

Capabilities of our Clinical Studies Team

In-Vivo models include:

Salivary Peroxide

Dental Plaque pH

Sensitivity

Tooth Stain

Whitening

Salivary Flow and pH Buffering

 

In-Situ models include:

Caries Prevention

Erosion

Remineralization

Plaque Accumulation

Demineralization

Whitening

Abrasion

  

 

 

 

                           

 

  • All Studies are conducted with certified, accredited and licensed personnel

 

  • Customized protocol and study design planning

 

  • IRB submissions to an independent IRB with rapid start-up times (typically 1.5 to 3 weeks)

 

  • Data security and subject confidentiality

 

  • Ease of developing contracts (No requirement for publication rights or issues regarding data ownership)

 

  • Subject recruitment and consenting

 

  • Infection control and supply chain support

 

  • Statistical analysis and detailed reports

 

 

 

 

 

 

 

                                            

  • Fluoride Dentifrices 

  • Fluoride Rinses

  • Products for the Temporary Relief of Dry Mouth

  • Products to Help Prevent or Reduce Enamel Erosion

  • In situ Remineralization/Demineralization Testing

  • Sugar Free Chewing Gum to Help Prevent Cavities

"The ADA Council on Scientific Affairs' Qualification of Therametric Technologies, Inc. is based on its finding that the facility has demonstrated their ability to generate accurate, valid and reliable clinical and laboratory data in conducting sponsor's research-related duties and functions in support of ADA Seal of Acceptance Program product submissions."

Quality Testing     Timely Results

9880 Douglas Floyd Parkway

Noblesville, IN 46060

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