Research Clinic

PI: Cyndee Stull

Sponsor: University of Minnesota Veden

One of the goals of this study is to examine the perceptions of patients toward an enhanced oropharyngeal cancer screening examination performed by students attending the University of Minnesota, School of Dentistry.

Timeline: The estimated time spent by patients is one (1) hour for the appointment which includes the enhanced exam, consent, study forms, and questionnaire.

Inclusion Criteria:

• Adults between the ages of 35 and 70
• Patients of record at the University of Minnesota School of Dentistry
• English-speaking
• Able to read consent form and questionnaire and provide written informed
  consent

Compensation:

All patient participants will receive a $25.00 pre-paid debit card for completion of all study activities including participation in the oropharyngeal examination and upon completion of the survey.

Study Status:

Ongoing. Actively recruiting.

How to get involved?

Contact: Study Manager, Kelli Trauger, at 612-624-2231

PI: Estephan Moana-Filho DDS, MS, PhD

Sponsor: NIH/NIDCR

The overall goal of this study is to determine brain mechanisms in chronic TMD pain patients and pain-free controls using brain imaging and sensory testing.

Timeline: After screening to identify potential individuals, qualifying participants will complete three in-person study visits, two at the School of Dentistry and one at the MRI center (CMRR). The visits include a comprehensive clinical examination, filling out questionnaires, sensory testing, and a brain MRI scan session.

Major Inclusion Criteria:

• Female participants only (biological sex)
• Age between 18-65 tears.
• Pain-free participants OR Chronic jaw pain (> three months)

Major Exclusion Criteria:

• Certain medical conditions (examples: heart disease, diabetes, autism, trigeminal neuralgia).
• Any MRI contraindications (examples: metal implants, claustrophobia)
• Being left-handed only

Compensation: $250.00 plus parking validation if needed ($50 for completion of first visit, $100 for completion of second visit, $100 for completion of third visit).

Study Status:

Ongoing. Actively recruiting.

How to get involved?

Contact: [email protected], 612-625-8926

PI: Dr. Jorge Perdigao

Sponsor: 3M Company

The investigational device in this research study is Scotchbond™ Universal Plus (SBU+) Adhesive, which is manufactured by 3M. The intended purpose of SBU+ Adhesive is to be used as a bond-promoting substance between the tooth and dental restorations. It may also be used as a dentin sealant and as a bonding agent for repair of restorations. The comparator product (i.e., Control product) for the investigational device will be Scotchbond™ Universal (SBU) Adhesive, which is also manufactured by 3M.

The purpose of this research study is to compare SBU+ Adhesive with its predicate device (SBU Adhesive) in relation to functional aspects of the restorations. The follow-up period of 6, 12, and 24 months is based on previous 2-year studies of other composite resin adhesives showing differences in retention, fracture, and marginal adaptation scores.

Timeline:

Patients will first be screened at the dental school by the study dentist to look at teeth requiring dental fillings. Qualifying patients will attend five (5) appointments at the University of Minnesota (UMN) School of Dentistry (SOD) over 24 months. First visit will include an in-person screening to make sure they meet eligibility requirements. Once screened, participants will be scheduled for an appointment to place two composite (tooth colored) fillings using the 3M dental adhesives with three (3) additional follow-up visits after the fillings are placed at 6, 12, and 24 months to record data on each tooth.

Compensation:

A total of $300 will be paid in the form of a debit card; $50 after the filling appointment, $50 at 6-months, $100 at 12-months, and $100 at 24-months. In addition, up to $12 of parking will be  validated at the Washington Avenue Ramp on campus at the end of each appointment.

Inclusion Criteria:

1. Between the ages of 18 and 70 years old at time of consent
2. Needs at least two direct composite restorations for posterior Class I or Class II carious lesions in vital teeth that are asymptomatic and with minimal mobility (< 1 mm in the buccolingual direction)
3. Study teeth have a minimum buccolingual diameter of the occlusal surface that is at least 1/3 of the distance between the buccal and lingual cusps
4. Teeth selected for Class II restorations need to have an adjacent tooth in a position that will allow for a contact relationship to be established
5. Needs to read and understand the English language without assistance
6. Available for all scheduled study visits for the duration of 24 months
7. Good general health (i.e., meets ASA Level I or ASA Level II classification criteria)
8. The selected teeth need to have occlusal contact with an antagonistic natural tooth
9. Has existing radiographic images of the study teeth of current and acceptable diagnostic quality obtained within the previous 12 months (i.e., needs to be a patient of record at the UMN SOD)

Exclusion Criteria:

Preoperative exclusion criteria include the following:

1. Has a history of adverse reaction to any materials used in this study
2. Is pregnant or breast feeding at the time of screening
3. Fewer than 20 teeth
4. Is taking part in or planned to be enrolled in an evaluation of other restorative materials at any time during the study
5. Advanced periodontal disease (i.e., Grace & Smales Mobility Index grade ≥ 2) that involve the study teeth
6. Orthodontic appliance treatment within the previous 3 months
7. Pronounced enamel wear facets, indicting severe, on-going bruxism
8. Severe xerostomia
9. The study tooth has a history of or existing, prolonged tooth hypersensitivity
10. The study tooth is an abutment for fixed or removable prostheses
11. The study tooth has a fracture or is visibly cracked such that it may impact the longevity of the tooth
12. The carious lesion is stage RC5 or RC6 of the ICDAS radiographic scoring system
13. Unable to understand study procedures or provide consent in English
14. Is an employee or student of the study investigator(s)

Intraoperative exclusion criteria include the following:

1. Pulp exposure of either study tooth during restoration procedure

Study Status:

Ongoing. Closed for recruitment.

Do you have a patient who qualifies?

Contact Kelli Trauger at [email protected]

PIs: Michelle Arnett and Danna Paulson

Sponsor: FENO Labs Inc.

The overall goal of this study is to investigate a full-mouth electronic toothbrush (FMET) and foam system compared to a conventional electronic toothbrush (ETB) and dentifrice during a 30-day period to evaluate the impact on clinical indicators of gingivitis, plaque, safety, and patient perceptions.

Timeline:

30 days 

Inclusion Criteria:

• School of Dentistry patient of record who is 18+
• Documented recent x-rays, and mild to moderate gingivitis
• At least 5 natural teeth in each area: upper left, upper right, lower left, lower right
• Willing to avoid professional oral hygiene care and use of any other dental cleaning aids during the 30-day study period
• Access to an active email address/account

Exclusion Criteria:

• Uncontrolled gum disease
• Inability to perform self-oral care
• Some medications that affect gum conditions
• Uncontrolled medical conditions
• Pregnancy
• Smoking

Compensation:  

• Visit 1 (2 hours) - Parking validation.
• Visit 2 (30 days after Visit 1, 2 hours)- Parking validation and $100.00 after completion of all study activities and surveys, for a total of $100.00.

Study Status:

Ongoing, actively recruiting.

How to get involved?

Contact: Michelle Arnett, [email protected] or Danna Paulson, [email protected]

PI: Estephan Moana-Filho DDS, MS, PhD

Sponsor: UMN Frank Veden Endowment for Clinical Research

The overall goal of this study is to determine pain experiences in chronic TMD patients and pain-free controls using thermal/heat sensory testing.

Timeline: After screening to identify potential individuals, qualifying participants will complete questionnaires and daily ratings, and one in-person study visit at the School of Dentistry Oral Health Clinical Research Center. The in-person visit includes a comprehensive clinical examination, filling out questionnaires, pain testing, and completing all the daily pain rating forms. The overall for participation in this study is 7-14 days. 

Inclusion Criteria:

• Female and male participants
• Ages between 18 to 74 years
• Need to be pain-free or have chronic jaw pain (> three months)
• Willing to comply with all study procedures, including completing daily ratings before and after the in-person study visit, and be available for the duration of study participation.
• Participants will be matched for age within ±5 years, and all participants must be able to understand commands in English to follow study procedures during heat testing. 

Exclusion Criteria:

• Certain medical conditions (e.g., heart conditions/diseases, uncontrolled diabetes, hyperthyroidism, renal conditions, COPD/emphysema, seizures, etc.)
• Neurological disorders (e.g., dementia, autism spectrum disorder, neoplasm, multiple sclerosis, trigeminal neuralgia, etc.)
• History of major depression or other major psychiatric disorder requiring hospitalization within the last 6 months
• History of treatment for drug or alcohol abuse within the last 12 months
• Traumatic facial injury or surgery on the face/jaw, arms or hands
• Presence of pain related to dental and periodontal pathology
• Steroid injections/holistic therapies within the last 2 weeks
• Botox injections within the last three months
• Currently taking pain medications (e.g., opioids, NSAIDS/ibuprofen, acetaminophen) that cannot be stopped within a 24-hour period
• Adults lacking capacity to provide informed consent for themselves
• Unable to read and understand instructions for sensory testing in English
• Inability to complete at least four daily ratings before, during, and after the in-person study visit
• Lack of access to electronic device with internet connection during study participation
• Pregnancy

Compensation:

$50.00 for the in-person (~3.5 hours) study visit plus parking validation if needed. $100.00 for completion of all study procedures and pain rating forms, for a total of $150.00.

Study Status:

Ongoing. Actively recruiting.

How to get involved?

Contact: [email protected] or call 612-625-6976