Bromelain for Post-surgery Facial Swelling
ConditionMalocclusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMohamed Bazina
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
undergoing orthognathic surgery
Disqualifiers
craniofacial anomalies
incomplete patient data
systemic disease that could affect healing
allergy to latex or pineapple
Trial design
Design model
Parallel
Treatments tested in this trial
Bromelain
Dietary supplement1 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Bromelain SupplementExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, and post intervention weeks 1, 2, 4, and months 3 and 62
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.
Time frame
Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mohamed Bazina
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov