An interventional study of Bromelain and Standard postoperative medication in Impacted Third Molar Tooth, Postoperative Pain Control and Trismus, sponsored by Istanbul Kent University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Istanbul Kent University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether oral bromelain, a pineapple-derived enzyme supplement, reduces facial swelling, limited mouth opening (trismus), and pain after surgical removal of impacted lower wisdom teeth in healthy young adults. The main questions it aims to answer are:
Researchers compared each patient's recovery after two separate operations: one followed by standard medication alone and one followed by standard medication plus bromelain.
Participants:
This prospective, randomized, open-label, split-mouth trial was conducted at the Department of Oral and Maxillofacial Surgery, Istanbul Kent University Faculty of Dentistry. Forty systemically healthy patients (ASA I, aged 18-25 years) with bilaterally impacted mandibular third molars of comparable difficulty underwent two extractions performed by the same surgeon under local anesthesia, approximately two weeks apart. After both operations, patients received amoxicillin-clavulanic acid, flurbiprofen 100 mg as needed (up to twice daily), and benzydamine mouthwash. A computer-generated sequence determined whether oral bromelain (500 mg twice daily for 5 days, starting on the day of surgery) was added after the first or the second session. No placebo was used.
Facial swelling was assessed with linear facial measurements between anatomical reference points (canthus-mandibular angle, tragus-gnathion, tragus-nasion, tragus-commissure) and trismus as maximum interincisal opening, at baseline and on postoperative days 2 and 7. Pain was recorded on a 10-cm visual analog scale at 2, 6, 12, 24, 48, and 72 hours and on day 7, and flurbiprofen intake was recorded in a patient diary during the first postoperative week. Within-patient comparisons were analyzed with repeated-measures analysis of variance and Bayesian paired analyses.
107 studies on the registry are indexed under Trismus; 19 are open to participants now.
This study's enrollment of 40 is below the median of 52 across 99 interventional studies indexed under Trismus.
Browse Trismus studies →Istanbul Kent University is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Pregnancy or lactation
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgical session followed by oral bromelain in addition to standard postoperative medication.
Dietary Supplement: Bromelain · Drug: Standard postoperative medication
Contralateral surgical session followed by standard postoperative medication alone.
Drug: Standard postoperative medication
Oral bromelain 500 mg twice daily for 5 days, starting on the day of surgery, added to standard postoperative medication after one randomly allocated surgical session.
Amoxicillin-clavulanic acid twice daily for 7 days, flurbiprofen 100 mg as needed (up to twice daily), and benzydamine mouthwash three times daily for 7 days, given after both surgical sessions.
Facial Swelling
Facial swelling assessed by linear facial measurements (mm) between anatomical reference points using a flexible measuring tape: canthus-mandibular angle, tragus-gnathion, tragus-nasion, and tragus-commissure. Each distance was measured twice and the mean was recorded. Values were compared within patients between the bromelain and control sessions.
Time frame: Baseline (preoperative), postoperative day 2, and postoperative day 7
Trismus (Maximum Interincisal Opening)
Maximum interincisal opening (mm) measured between the incisal edges of teeth 11 and 41; trismus expressed as the reduction from baseline.
Time frame: Baseline (preoperative), postoperative day 2, and postoperative day 7
Postoperative Pain
Pain intensity rated by the patient on a 10-cm visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).
Time frame: 2, 6, 12, 24, 48, and 72 hours and day 7 after surgery
Analgesic Consumption
Cumulative number of flurbiprofen 100 mg tablets taken as needed, recorded by the patient on a standardized medication diary form.
Time frame: First 7 days after surgery
Plan to share: No — Individual participant data will not be publicly shared. De-identified data supporting the published results are available from the principal investigator upon reasonable request.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bromelains
Istanbul Kent University