Bromelain for Post-Surgery Facial Swelling

Overseen By Emma E Palmer, DMD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mohamed Bazina

Disqualifiers: Craniofacial anomalies, Systemic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a Bromelain supplement can reduce facial swelling after jaw surgery and affect the duration of the swelling. Bromelain, a natural substance found in pineapple, may ease and enhance recovery. Participants will take the Bromelain supplement once daily for nine days, beginning two days before surgery. Ideal candidates are those scheduled for jaw surgery without craniofacial anomalies or pineapple allergies. As an unphased trial, this study allows participants to contribute to understanding the potential benefits of a natural supplement in post-surgical recovery.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you will need to keep a log of when you take the Bromelain supplement and any other medications.

What prior data suggests that Bromelain is safe for post-surgery use?

A previous study used bromelain to help reduce swelling after surgery. Some research suggests it might not be effective for all types of swelling, such as after wisdom tooth removal. However, bromelain is generally safe for most people.

Mild side effects, like an upset stomach or diarrhea, may occur. There is also a risk of increased bleeding during and after surgery. Therefore, it is recommended to stop using bromelain at least two weeks before any planned surgery.

Overall, when considering bromelain for swelling, it is important to weigh the potential benefits against these safety concerns. Always consult a healthcare provider before starting any new supplement. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatment options for post-surgery facial swelling, which often involve anti-inflammatory medications like NSAIDs or corticosteroids, bromelain offers a natural alternative. Bromelain is an enzyme found in pineapples and is known for its anti-inflammatory and pain-relieving properties. Researchers are excited about bromelain because it might reduce swelling more naturally and with potentially fewer side effects compared to traditional medications. Plus, it's taken as a simple supplement, which could make it easier for patients to manage during their recovery.

What evidence suggests that Bromelain might be an effective treatment for post-surgery facial swelling?

This trial will evaluate the effects of bromelain on post-surgery facial swelling. Research has shown that bromelain, a natural enzyme in pineapple, might help reduce swelling and speed up recovery after surgery. Some studies suggest that bromelain works better than common painkillers like paracetamol and codeine for reducing swelling after oral surgery. However, other research did not find strong proof that bromelain helps with facial swelling after certain dental surgeries. Despite these mixed results, consistent evidence indicates that bromelain can lessen pain and swelling and improve quality of life after oral surgery. It's important to consider these varied findings when evaluating bromelain's potential benefits. ^{1 3 6 7 8}

Who Is on the Research Team?

Mohamed Bazina, DDS, MSD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals undergoing jaw surgery to correct misaligned teeth or malocclusion. Participants must be willing to take Bromelain supplements daily for 9 days around their surgery and keep a medication log. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am scheduled for corrective jaw surgery.

Exclusion Criteria

History of craniofacial anomalies

Incomplete patient data

I have a condition that could slow down my healing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Treatment

Participants take Bromelain supplement once daily for 2 days before surgery

2 days

1 visit (in-person) for pre-surgical protocol

Post-surgery Treatment

Participants take Bromelain supplement once daily for 7 days following surgery

1 week

1 visit (in-person) for post-surgical protocol

Follow-up

Participants are monitored for changes in facial swelling using Vectra 3D imaging

6 months

Visits at weeks 1, 2, 4, and months 3 and 6

What Are the Treatments Tested in This Trial?

Interventions

• Bromelain

Trial Overview The study tests whether taking Bromelain can reduce facial swelling after jaw surgery, both in severity and duration. Patients will take the supplement two days before and seven days after the operation, while also attending clinic visits as part of pre- and post-surgical protocol.

How Is the Trial Designed?

Group I: Bromelain Supplement Experimental Treatment 1 Intervention

1000mg bromelain supplement once a day, 2 days prior to and 7 days following surgery

Group II: Control Active Control 1 Intervention

Standard of care

Who Is Running the Clinical Trial?

Mohamed Bazina

Lead Sponsor

Trials

1

Recruited

60+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10889715/

Reduction of Post-Surgical Facial Edema Following Bromelain ... Conclusions: These findings seem to provide evidence that Brovas® may be effective in improving postoperative edema outcomes in patients ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667147623000614

Effectiveness of oral bromelain on third molar surgery ... did not find any evidence that bromelain effectively reduced trismus and facial swelling following the third molar surgery [14]. None of the included ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/cre2.70124

Analgesic Efficacy of Bromelain and ... Bromelain was found to be more effective than paracetamol and codeine in decreasing inflammation, edema, and trismus after oral surgical ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6344017/

Efficacy of proteolytic enzyme bromelain on health outcomes ... No evidence was found that bromelain was effective in reducing trismus and facial swelling. Conclusions. The currently available evidence suggests that ...

5. consensus.app consensus.app/search/how-has-bromelain-improved-patient-outcomes/9fAcO3YYTCWrMlz0a45kGg/

How has bromelain improved patient outcomes? Research consistently shows that bromelain can reduce pain, swelling, and improve quality of life after oral surgery ... facial trauma surgery, bromelain ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07115212

NCT07115212 | Bromelain for Post-surgery Facial Swelling 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 ...

7. webmd.com webmd.com/vitamins/ai/ingredientmono-895/bromelain

Bromelain - Uses, Side Effects, and More Surgery: Bromelain might increase the risk of bleeding during and after surgery. Stop using bromelain at least 2 weeks before a scheduled surgery. Interactions ...

8. uky.trialstoday.org uky.trialstoday.org/trial/NCT07115212

Bromelain for Post-surgery Facial Swelling Purpose. The goal of this clinical trial is to learn if Bromelain Supplement works to decrease the amount of swelling or the amount of time ...