Impacted Third Molar ToothNCT07894913
Oral Bromelain After Bilateral Mandibular Third Molar Surgery
A study testing Bromelain and Standard postoperative medication in people with Impacted Third Molar Tooth and Postoperative Pain Control, run by Istanbul Kent University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Impacted Third Molar Tooth, Postoperative Pain Control, Trismus
- What is being tested?
- Bromelain and Standard postoperative medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2024to 22 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 25 years
- ASA physical status I
- Bilateral impacted mandibular third molars of comparable surgical difficulty (Pell and Gregory Class A-B, Position I)
- Non-smoker
- Good oral hygiene
- Able to attend all follow-up visits
- Written informed consent
Who cannot join
- Pregnancy or lactation
- Acute pericoronitis
- Periodontal disease of the adjacent teeth
- Allergy to bromelain, pineapple, or any of the study drugs
- Systemic inflammatory or immunological disease
- Diabetes mellitus
Show all 11Show fewer
- Coagulation disorders
- Current corticosteroid or immunosuppressive therapy
- Use of antibiotics or anti-inflammatory drugs within 2 weeks before surgery
- Surgical time longer than 60 minutes
- Intraoperative complications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul kent university
Istanbul, Beyoglu, 34443
About this study
Official title: Adjunctive Oral Bromelain After Bilateral Mandibular Third Molar Surgery: A Prospective Randomized Split-Mouth Clinical Trial of Postoperative Pain, Facial Swelling, and Trismus
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:
- Does adding bromelain to standard postoperative medication reduce facial swelling and trismus?
- Does it reduce postoperative pain and the number of painkillers taken?
Read more
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:
- Had both impacted lower wisdom teeth removed in two separate sessions about two weeks apart
- Took bromelain (500 mg twice daily for 5 days) after one randomly selected session
- Had facial swelling and mouth opening measured before surgery and on days 2 and 7
- Rated their pain at set times during the first week and recorded the painkillers they took
Read the detailed description
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.
- Being tested
- Bromelain, Standard postoperative medication
- Keywords
- Bromelain, Third Molar Surgery, Split-Mouth Design, Dietary Supplement
- Medical subject headings
- Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromelainDietary supplement
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.
Standard postoperative medicationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Bromelain + standard care | Experimental | Surgical session followed by oral bromelain in addition to standard postoperative medication. Receives: Dietary Supplement: Bromelain; Drug: Standard postoperative medication |
| Standard care | Active comparator | Contralateral surgical session followed by standard postoperative medication alone. Receives: Drug: Standard postoperative medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (preoperative), postoperative day 2, and postoperative day 7
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: First 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start16 Jun 2024
- Primary completion22 Feb 2025
- Study completion22 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth (within-person) design. Each participant underwent extraction of both impacted mandibular third molars in two separate surgical sessions approximately two weeks apart. Bromelain was added to standard postoperative medication after one session, and standard medication alone was given after the other; the order was determined by a computer-generated random sequence. Each participant served as their own control.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Tuna Demir, Istanbul Kent University
- Investigators
- Emine tuna Demir, DDS, PhD, Principal investigator, Istanbul Kent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894913
- Sponsor's protocol ID
- 2015-KAEK-80-23-11
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Oral Bromelain After Bilateral Mandibular Third Molar Surgery: A Prospective Randomized Split-Mouth Clinical Trial of Postoperative Pain, Facial Swelling, and Trismus
- ClinicalTrials.gov ID
- NCT07894913
- Acronym / sponsor ID
- 2015-KAEK-80-23-11
- Keywords
- Bromelain, Third Molar Surgery, Split-Mouth Design, Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Kent UniversityUniversity, hospital or other
- Study start
- 16 Jun 2024 (actual)
- Primary completion
- 22 Feb 2025 (actual)
- Study completion
- 22 Feb 2025 (actual)
- First posted
- 26 Oct 2026 (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 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:
- Does adding bromelain to standard postoperative medication reduce facial swelling and trismus?
- Does it reduce postoperative pain and the number of painkillers taken?
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:
- Had both impacted lower wisdom teeth removed in two separate sessions about two weeks apart
- Took bromelain (500 mg twice daily for 5 days) after one randomly selected session
- Had facial swelling and mouth opening measured before surgery and on days 2 and 7
- Rated their pain at set times during the first week and recorded the painkillers they took
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-mouth (within-person) design. Each participant underwent extraction of both impacted mandibular third molars in two separate surgical sessions approximately two weeks apart. Bromelain was added to standard postoperative medication after one session, and standard medication alone was given after the other; the order was determined by a computer-generated random sequence. Each participant served as their own control.
| Arm | Type | Receives |
|---|---|---|
| Bromelain + standard care | Experimental | Dietary Supplement: Bromelain, Drug: Standard postoperative medicationSurgical session followed by oral bromelain in addition to standard postoperative medication. |
| Standard care | Active comparator | Drug: Standard postoperative medicationContralateral surgical session followed by standard postoperative medication alone. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 to 25 years
- ASA physical status I
- Bilateral impacted mandibular third molars of comparable surgical difficulty (Pell and Gregory Class A-B, Position I)
- Non-smoker
- Good oral hygiene
Key exclusion criteria (11 listed)
- Pregnancy or lactation
- Acute pericoronitis
- Periodontal disease of the adjacent teeth
- Allergy to bromelain, pineapple, or any of the study drugs
- Systemic inflammatory or immunological disease
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 |
|---|---|---|
| BromelainOral 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. | Dietary supplement | Bromelain + standard care |
| Standard postoperative medicationAmoxicillin-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. | Drug | Bromelain + standard care, Standard care |
Primary outcome
Facial Swelling
Time frame: Baseline (preoperative), postoperative day 2, and postoperative day 7
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.
3 secondary outcomes
Trismus (Maximum Interincisal Opening)
Time frame: Baseline (preoperative), postoperative day 2, and postoperative day 7
Postoperative Pain
Time frame: 2, 6, 12, 24, 48, and 72 hours and day 7 after surgery
Analgesic Consumption
Time frame: First 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
Emine tuna Demir, DDS, PhD principal investigator
Istanbul Kent University
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 and Standard postoperative medication in people with Impacted Third Molar Tooth and Postoperative Pain Control, run by Istanbul Kent University at 1 site in Turkey (Türkiye).
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 26 Oct 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Swelling (time frame: Baseline (preoperative), postoperative day 2, and postoperative day 7). 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 26 Oct 2026.