Bromelain for Post-surgery Facial Swelling

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Mohamed Bazina
Study ID
NCT07115212
Status
Recruiting

Conditions

  • Malocclusion

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Sep 8, 2025
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Bromelain Supplement
    1000mg bromelain supplement once a day, 2 days prior to and 7 days following surgery
  • No Intervention: Control
    Standard of care

Primary Outcome Measure

Change in Volume of Swelling [ Time Frame: Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40356-

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