Bromelain for Post-surgery Facial Swelling

NCT07115212 — Not applicable, Recruiting, 200 participants, Mohamed Bazina

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Effectiveness of Bromelain Supplement in Reduction of Facial Swelling Caused by Orthognathic Surgery

Registry	NCT07115212
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	200 (Estimated)
Sponsor	Mohamed Bazina (Other)
Conditions	Malocclusion
Interventions	Bromelain (Dietary supplement)
Dates	start 2025-09-08, primary completion 2028-05-01 (estimated), completion 2028-05-01 (estimated), first posted 2025-08-11, last updated 2026-06-05
Locations	1 site in United States

-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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Bromelain Supplement	Experimental	Dietary Supplement: Bromelain	1000mg bromelain supplement once a day, 2 days prior to and 7 days following surgery
Control	No intervention		Standard of care

Bromelain (Dietary supplement), also known as Naturebell: 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.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
University of Kentucky	Lexington, Kentucky	United States	Recruiting

+Investigators

Mohamed Bazina, DDS, MSD, Principal investigator, University of Kentucky