Current Clinical Studies

Current Studies

All studies have been reviewed and approved by the University of Minnesota’s Institutional Review Board (IRB).

The Restful Jaw Device: A New Way to Support and Protect the Jaw During Third Molar Extractions

The Restful Jaw Device: A New Way to Support and Protect the Jaw During Third Molar Extractions

PI:  Rachel Uppgaard                                                             Sponsor:  NIH/NIDCR

The Restful Jaw device supports the jaw during dental procedures, including 3rd molar (wisdom tooth) extractions, when a downward force is placed on it. The device is designed to be effective in a wide range of patients for decreasing jaw pain, discomfort, and fatigue. It attaches to the headrest of the dental chair and supports under both sides of the patient’s jaw.

The aim of this randomized clinical trial is in patients having mandibular 3rd molar extractions with moderate/deep sedation, compare the incidence of TMD/TMJ pain between these two groups within a 6-month follow-up:

(1) Usual Care group: the dental assistant supports the jaw with their hands, and

(2) Experimental Care group the Restful Jaw Device supports the jaw. 

Timeline: Qualifying patients will have 1 visit on the day of surgery for removal of 3rd molars. Additional follow-up surveys will be completed via email at 1, 3 and 6 months after surgery. 

Compensation:  $25.00 on the day of surgery, $25 each upon completion of surveys at 1 and 3 month after surgery, and $50 at the completion of a survey  6-months after surgery ($125 total).

Inclusion Criteria

  1. Between 18 to 30 years of age at time of enrollment.
  2. In past 3 months, has not had pain in the jaw or temple.
  3. In past 3 months, has had no pain in the jaw when opening wide.
  4. Have an email account.
  5. Willing to provide informed consent to be randomized between using the device or not using the device.
  6. Needs removal of bilateral mandibular (lower) 3rd molarswith sedation. (concurrent maxillary (upper) 3rd molar extractions allowed).
  7. Healthy patients or patients with mild systemic disease. 

Exclusion Criteria

  1. Contra-indication for moderate/deep sedation or general anesthesia.
  2. Any condition that the surgeon feels would prevent them from participating in the study.
  3. Unable to understand English.
  4. Not available for follow-up over a 6-month period.

How to get involved?

Contact: Contact Kimberly Johnson, study manager, at: Kimberly.S.Johnson@healthpartners.com

Scaling and root planing (SRP) with and without monocycline spheres

Scaling and root planing (SRP) with and without monocycline spheres

PI: Michelle Arnett RDH, BS, MS

Sponsor: Bausch Health Co.

This randomized clinical trial is comparing scaling and root planning (SRP) with and without minocycline for treatment of periodontitis over a 6-month period. Saliva samples, gingival crevicular fluid (GCF), and blood serum will be collected at four time points (baseline, 1, 3, and 6 month follow up). Saliva will be analyzed for overall pathogen burden. GCF will be analyzed for IL-1, IL-6, and TNF-α. Serum will be analyzed for inflammatory markers.

Timeline:

Qualifying participants will receive a deep cleaning and two teeth cleanings over a six month period at no cost.  There are four visits total that will range from 1-3 hours long, most commonly scheduled on Wednesdays.

Major Inclusion Criteria:

  • Be at least 21 years old
  • Have Periodontitis (gum disease)
  • Need localized or generalized deep teeth cleaning
  • Have a minimum of eight sites with pockets ≥5mm with bleeding on probing
  • Willingness to fulfill all study requirements

Major Exclusion Criteria:

  • Had a localized or generalized deep cleaning in the last six months
  • Cigarette use within the last year
  • Long-term antibiotic use
  • Pregnant, planning to become pregnant, or unsure of pregnancy status and mothers who are breastfeeding
  • Diagnosed cardiac conditions, any uncontrolled medical conditions, or immunocompromised
  • Tetracycline allergy, or taking medication that effects gum tissues

Compensation:

Payment is prorated with $200 available for completion of all study visits.

How to get involved?

Contact:

Michelle Arnett, RDH, BS, MS at marnett@umn.edu or (612) 624-3457, or

Danna Hickey, RDH, MSDH, study coordinator, at hicke097@umn.edu or (612) 626-4744

Prediction of Periodontitis Using NMR Metabolmics

Prediction of Periodontitis Using NMR Metabolmics

PI: Massimo Costalonga DMD, PhD                   

Sponsor: Schaffer Chair Fund and Faculty Research Development Grant Award from the AHC - Office of Vice President for Research

This prospective study is assessing the association between the metabolites in the gingival crevicular fluid in patients with periodontitis or peri-implantitis versus controls. Follow-up is done every 6-months over a 2 year period with clinical and radiographic assessment of teeth or implants as well as collection of gingival crevicular fluid.

Timeline: Qualifying individuals will have 4 visit at 6 month intervals for 2 years

At each visit PD measurements will be recorded 

Major Inclusion Criteria:     

  • Subject must be diagnosed with:
  • Periodontitis: must be diagnosed with generalized chronic severe periodontal disease with at least one (1) site with a pocket depth of  ≥ 7 mm with radiographic evidence of 30-50% bone loss.

Or

  • Peri-Implantitis: must be diagnoses with several peri-implantitis (at least one site around the affected implant with a periodontal pocket ≥ 7 mm) and radiographic evidence of at least 30% bone loss (alveolar bone crest be assured from the implant-abutment interface in at least 1 or 2 or more implants present.

Major Exclusion Criteria: 

  • Uncontrolled systemic disease, such as diabetes
  • Systemic antibiotics use within the past 3 months
  • History of periodontal treatment or local antibiotic use in the past 12 months

Compensation:  $35.00 at each visit

How to get involved?

Contact: Massimo Costalonga, PhD, DMD - costa002@umn.edu

Impact of Brief Motivational Interviewing (BMI) during continuous patient care to enhance oral hygiene

Impact of Brief Motivational Interviewing (BMI) during continuous patient care to enhance oral hygiene

PI: Michelle Arnett RDH, BS, MS

Sponsor: Tenure track start-up fund

This randomized clinical trial is assessing if the utilization of Brief Motivational Interviewing (BMI) during continuous care is superior compared to traditional oral hygiene instructions (OHI) to reduce patients’ plaque score, bleeding on probing (BOP), and gingival index (GI).

This study is no longer recruiting subjects.

Brain Mechanisms Underlying Endogenous Pain Modulation in Chronic TMJD

Brain Mechanisms Underlying Endogenous Pain Modulation in Chronic TMJD

PI: Estephan Moana-Filho DDS, MS, PhD           Sponsor: NIH/NIDCR

The overall goal of this study is to determine brain mechanisms of endogenous pain modulation in chronic TMD pain patients and matched controls using comprehensive phenotyping of clinical and psychosocial characteristics, somatosensory function testing using validated protocol, and multimodal MRI neuroimaging.

Timeline: After a phone screening to identify qualifying individuals the participants will visit the School of Dentistry on three separate occasions. The visits include a comprehensive clinical TMJ examination, sensory/pain testing using touch, pressure, and hot/cold, and a final visit will include a brain MRI scan along with the completion of several questionnaires.

Major Inclusion Criteria:

  • Female between the ages of 18 and 65 years old
  • Must be diagnosed with chronic TMD pain

Major Exclusion Criteria:

  • Current pain medication used that cannot be stopped at least 1 day prior to testing
  • Conditions/diseases that alter pain perception
  • Substance abuse
  • Conditions not allowing the use of an MRI such as claustrophobia or pregnancy
  • Non-English speakers

Compensation: $200.00 to be paid for completion of 3 clinical visits and voucher for parking.

How to get involved?

Contact: Patt Carlson GDH, BS, CCRP, study coordinator, at carls006@umn.edu or 612-624-9669.

Hydrogen Peroxide in the Clinic to Minimize Risk of COVID-19

Hydrogen Peroxide in the Clinic to Minimize Risk of COVID-19

PI: Rachel Uppgaard                                                  

Sponsor: School of Dentistry Frank W Veden Endowment for Clinical Research Fund

The purpose of this project is to assess the impact on patient’s post-operative symptoms when using 1% hydrogen peroxide pre-operatively and intra-operatively. This study will allow for evaluation of this newly established usual care (UC) in the division of oral and maxillofacial surgery of using 1% hydrogen peroxide when extracting teeth.

The aim of this study is to assess the outcome of using 1% hydrogen peroxide pre-operatively and intra-operatively during oral surgery.

Timeline: Patient will have one visit on the day of surgery for removal of 1-2 teeth. Follow-up will occur via phone interview with a photo upload to evaluate the surgical site(s). Phone interviews will occur Day 1, 7, 14, and 30 after extraction(s). Photo uploads will occur Day 7, 14, and 30.

Compensation: $10.00 gift cards provided upon completion of survey and photo uploads at enrollment, Day 1, Day 7, Day 14, and Day 30.

Inclusion Criteria:

1. 18-65 years of age

2. 1 – 2 teeth requiring extraction

3. 75 consecutive patients that present to the School of Dentistry’s Division of Oral and Maxillofacial Surgery clinic for extraction of one or two teeth. 

4. Willing to participate

5. Has an active email address

6. Has a cell phone/iPad/tablet capable of taking intra-oral photos and uploading them into REDCap

7. Available for the duration of study

Exclusion Criteria:

1. Unable to understand English

2. The oral & maxillofacial  surgeon (OMS) determines that it is not appropriate for the patient to participate in the study

3. Unable to receive telephone calls from the Principal Investigator

4. Unable to upload photos into REDCap

How to get involved?

Contact Kimberly Johnson, study manager, at Kimberly.S.Johnson@healthpartners.com