MalocclusionNCT07115212
Bromelain for Post-surgery Facial Swelling
A study testing Bromelain in people with Malocclusion, run by Mohamed Bazina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- Bromelain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing orthognathic surgery
Who cannot join
- craniofacial anomalies
- incomplete patient data
- systemic disease that could affect healing
- allergy to latex or pineapple
- under 18 years of age
- non english speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40356
About this study
Official title: Effectiveness of Bromelain Supplement in Reduction of Facial Swelling Caused by Orthognathic Surgery
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?
Read more
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
- Being tested
- Bromelain
- Keywords
- Bromelain, Oral Supplements
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromelainDietary supplement
Also called Naturebell
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 group | Role | What they receive |
|---|---|---|
| Bromelain Supplement | Experimental | 1000mg bromelain supplement once a day, 2 days prior to and 7 days following surgery Receives: Dietary Supplement: Bromelain |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start8 Sep 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Bazina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Bazina, University of Kentucky
- Investigators
- Mohamed Bazina, DDS, MSD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115212
- Sponsor's protocol ID
- 99500
- Status last verified
- May 2026
- First submitted
- 4 Aug 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bromelain Supplement in Reduction of Facial Swelling Caused by Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT07115212
- Acronym / sponsor ID
- 99500
- Conditions
- Malocclusion
- Keywords
- Bromelain, Oral Supplements
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mohamed BazinaUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bromelain Supplement | Experimental | Dietary Supplement: Bromelain1000mg bromelain supplement once a day, 2 days prior to and 7 days following surgery |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing orthognathic surgery
Key exclusion criteria (6 listed)
- craniofacial anomalies
- incomplete patient data
- systemic disease that could affect healing
- allergy to latex or pineapple
- under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BromelainAlso: Naturebell1 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. | Dietary supplement | Bromelain Supplement |
Primary outcome
Change in Volume of Swelling
Time frame: Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6
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.
Duration of Swelling following Orthognathic Surgery
Time frame: Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Bazina, DDS, MSD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bromelain in people with Malocclusion, run by Mohamed Bazina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma E Palmer, DMD (859-358-6346, emma.palmer@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Volume of Swelling (time frame: Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.