University of Iowa College of Dentistry
Iowa City, Iowa, 52242, United States
NCT Number: NCT06406751
The purpose of this study is to determine if MI Paste affects the bacteria and fungus present within the mouth, as well as to determine if MI Paste increases denture comfort and retention. MI Paste is a water-based topical dental product that is available without a prescription. It is generally used to treat dental/tooth hypersensitivity (sensitive teeth) in patients and/or to help re-mineralize the tooth enamel in patients. Within this study, there is an off-label use for research subjects to apply above the upper denture.
Interested in participating?
Request Info65 year–105 year
All sexes
Interventional
Not applicable
Iowa City, Iowa, 52242, United States
Potentially-eligible subjects will be invited to the research study that involves consenting and 4 in-person visits (Screening Visit, Visit 1, Visit 2, Visit 3) where the following will be performed at each visit: (i) upper denture/mouth tissues swab sample collected, (ii) survey questions being administered, and (iii) brief oral dental exam (clinical assessment). Furthermore, at Visit 2, subjects will be provided and instructed on how to use MI Paste under their removable upper denture for 14 days and instructed to monitor symptoms of comfort, retention, and dry mouth (if applicable).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sterile swabs will be used to collect plaque from under the subject's upper denture (when the denture is removed) and the subject's mouth tissues. This will be used for genomic DNA, bacteria analysis, and fungus analysis. Subjects will also apply 1 cubic centimeter of MI Paste to the fitting surface on a daily basis for 14 days. Afterward, subjects will return to the clinic for another sterile swab to be collected.
Time frame: Multiple time points (baseline, two weeks, and four weeks)
16S genomic profiling will be done in all recruited subjects via oral swab from under the denture and mouth tissues.
University of Iowa
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05056948
Dental Prosthesis
Sai Ying Pun, Hong Kong
View Trial DetailsNCT06929689
Dental Implant, Dental Prosthesis
Alexandria, Egypt
View Trial DetailsNCT06862401
Dental Education and Special Care Dentistry, Dental Prosthesis
View Trial DetailsNCT06513767
Dental Prosthesis
View Trial Details