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NCT Number: NCT07115212

Bromelain for Post-surgery Facial Swelling

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

Recruiting

Interested in participating?

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40356, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Naturebell

Primary outcomes

  1. Change in Volume of Swelling

    Time frame: 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.

  2. Duration of Swelling following Orthognathic Surgery

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma E Palmer, DMD

CONTACT

[email protected]

859-358-6346

Sponsors and collaborators

Lead sponsor

Mohamed Bazina

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 11, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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