Malocclusion
Conditions
Keywords
Bromelain, Oral Supplements
Brief summary
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
Interventions
DIETARY_SUPPLEMENTBromelain
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.
Sponsors
Mohamed Bazina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* undergoing orthognathic surgery
Exclusion criteria
* craniofacial anomalies * incomplete patient data * systemic disease that could affect healing * allergy to latex or pineapple * under 18 years of age * non english speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Volume of Swelling | Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6 | 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. |
| Duration of Swelling following Orthognathic Surgery | Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6 | 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. |
Countries
United States
Contacts
CONTACTEmma E Palmer, DMD
PRINCIPAL_INVESTIGATORMohamed Bazina, DDS, MSD
University of Kentucky
Outcome results
None listed