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The goal of this clinical trial is to learn if Bromelain Supplement works to decrease the amount of swelling or the amount of time swelling is present following jaw surgery. It will also learn about the safety of Bromelain supplement. The main questions it aims to answer are:
Does Bromelain decrease facial swelling following orthognathic, or jaw, surgery? Does Bromelain supplement decrease the amount of time that patients are swollen following orthognathic, or jaw, surgery?
Participants will:
Take Bromelain supplement once daily for 9 days total. Take 2 days before surgery and 7 days following surgery.
Keep a log of when the bromelain supplement is taken as well as another other medications.
Visit the clinic with pre and post surgical protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bromelain Supplement | Experimental | 1000mg bromelain supplement once a day, 2 days prior to and 7 days following surgery |
|
| Control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromelain | Dietary Supplement | 1 tablet daily with water, for 9 days-starting 2 days before surgery and continuing for 7 days after. Record each dose in the provided log, along with any other medications taken and the time they were taken. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Volume of Swelling | Images will be obtained with the Vectra 3D imaging system to look at the volume of swelling in patients that undergo orthognathic surgery and measured in Cubic Centimeters. Will also have a heat map to visually show where swelling has increased or decreased since previously obtained imaging. All these images and measurements will be compared between the control and experimental groups. | Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6 |
| Duration of Swelling following Orthognathic Surgery | Images will be obtained with the Vectra 3D imaging system to look at the volume of swelling in patients that underwent orthognathic surgery at multiple time periods. With comparisons of these multiple photos the duration of swelling can be assessed and compared to the average amount of time it takes swelling to go down in a patient not taking bromelain supplement. | Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma E Palmer, DMD | Contact | 859-358-6346 | emma.palmer@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Bazina, DDS, MSD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40356 | United States |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D001963 | Bromelains |
| ID | Term |
|---|---|
| D003546 | Cysteine Endopeptidases |
| D057056 | Cysteine Proteases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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|
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010450 | Endopeptidases |