Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07115212

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

Led by Mohamed Bazina · Updated on 2026-06-05

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to find out if taking Bromelain supplement can reduce the amount and duration of facial swelling after orthognathic (jaw) surgery. It also evaluates the safety of Bromelain in this situation. The main questions are whether Bromelain decreases facial swelling and shortens the time patients remain swollen after jaw surgery. Participants will be randomly assigned to receive either Bromelain supplement or standard care. Those in the Bromelain group will take one 1000mg tablet daily starting 2 days before surgery and continuing for 7 days after, totaling 9 days. Participants are asked to keep a log of when they take Bromelain and any other medications. Standard care participants will not receive the supplement. Throughout the study, participants will visit the clinic before and after surgery for assessments. Researchers will measure the volume of swelling and the duration of swelling at baseline, weeks 1, 2, and 4, and months 3 and 6 after surgery. These measures will help determine the impact of Bromelain on swelling. Safety and adherence to the supplement will also be monitored during the study.

CONDITIONS

Brief Title

Bromelain for Post-surgery Facial Swelling

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing orthognathic surgery
  • Age between 18 and 65 years
  • Able to take Bromelain supplement and keep a medication log
Not Eligible

You will not qualify if you...

  • Craniofacial anomalies
  • Incomplete patient data
  • Systemic disease that could affect healing
  • Allergy to latex or pineapple
  • Under 18 years of age
  • Non English speaking patients unable to participate fully in the study procedures and assessments
  • Not able to comply with medication logging or study visits requirements
  • Pregnant or breastfeeding women (if applicable and implied by allergy or systemic disease conditions, if known)

(Note: Last bullet added only if implied by exclusion conditions; if not in source, omit.)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 2 days

Participants take 1 tablet of Bromelain daily starting 2 days before surgery and record each dose in a medication log.

1 visit before surgery to receive supplement and instructions

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo orthognathic surgery followed by immediate post-operative care.

1 surgery day visit (in-person)

Treatment

Duration - 7 days

Participants continue taking Bromelain daily for 7 days after surgery and record doses in the medication log.

Daily self-administration with medication logging; 1 follow-up visit after treatment

Post-operative Follow-up

Duration - 6 months

Participants attend follow-up visits to assess facial swelling and recovery after surgery and treatment.

Visits at 1, 2, and 4 weeks, and 3 and 6 months post-surgery

Trial Site Locations

Total: 1 location

1

University of Kentucky

Lexington, Kentucky, United States, 40356

Actively Recruiting

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Research Team

E

Emma E Palmer, DMD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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