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RecruitingNCT07115212Updated Jun 5, 2026

Bromelain for Post-surgery Facial Swelling

An interventional study of Bromelain in Malocclusion, sponsored by Mohamed Bazina. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Mohamed Bazina · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Malocclusion

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Keywords

  • Bromelain
  • Oral Supplements
03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 200 is above the median of 37 across 242 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Mohamed Bazina is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • undergoing orthognathic surgery

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Bromelain Supplement

    1000mg bromelain supplement once a day, 2 days prior to and 7 days following surgery

    Dietary Supplement: Bromelain

  • No intervention
    Control

    Standard of care

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.

    Also known as: Naturebell

06

What researchers measure

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 6

  2. 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 6

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07115212
Lead sponsor
Mohamed Bazina
Responsible party
Mohamed Bazina (Assistant Professor, University of Kentucky) — Sponsor-investigator
First posted
Aug 11, 2025
Start date
Sep 8, 2025
Primary completion
May 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Jun 5, 2026

Study contacts

Emma E Palmer, DMD
Contact
emma.palmer@uky.edu
859-358-6346
Mohamed Bazina, DDS, MSD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Bromelains

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