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Recruiting NCT07115212

Bromelain for Post-surgery Facial Swelling

No phase Interventional Malocclusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bromelain.
Who it may be relevant to
Registry conditions: Malocclusion. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Dietary supplement Bromelain
    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.

Primary outcome measures

  • Change in Volume of Swelling [Time frame: Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6]
  • Duration of Swelling following Orthognathic Surgery [Time frame: Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Kentucky — Lexington

Identifiers

NCT: NCT07115212 · 99500

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗