Recruiting

Bromelain

Sponsor:

Mohamed Bazina

Code:

NCT07115212

Conditions

Malocclusion

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Bromelain

Study Details

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

Study ID

NCT07115212

Start date

Sep 8, 2025

Status verified date

May, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Emma E Palmer, DMD

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

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40356

More Information

Sponsor

Mohamed Bazina

Last update posted

Jun 5, 2026

Last verified

May, 2026

Keywords

  • Bromelain
  • Oral Supplements

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mohamed Bazina on 2026-06-05.