Bromelain for Post-surgery Facial Swelling

NCT07115212 | Recruiting

• 1 other identifier: 99500
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Malocclusion

Keywords

Bromelain; Oral Supplements

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6

• 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.

  Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6

Study Arms (2)

Bromelain Supplement

EXPERIMENTAL

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

Dietary Supplement: Bromelain

Control

NO INTERVENTION

Standard of care

Interventions

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.

Also known as: Naturebell

Bromelain Supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing orthognathic surgery

You may not qualify if:

• craniofacial anomalies
• incomplete patient data
• systemic disease that could affect healing
• allergy to latex or pineapple
• under 18 years of age
• non english speaking

Sponsors & Collaborators

• Mohamed Bazina: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40356, United States

RECRUITING

MeSH Terms

Conditions

Malocclusion

Interventions

Bromelains

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cysteine Endopeptidases; Cysteine Proteases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Endopeptidases

Study Officials

• Mohamed Bazina, DDS, MSD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma E Palmer, DMD

CONTACT

859-358-6346; emma.palmer@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: September 8, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)