Post Operative PainPhase 3NCT05681312
Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and QoL After Surgical Extraction of Impacted Mandibular Third Molars
A Phase 3 study testing systemic proteolytic enzyme (Tibrolin) and Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg in people with Post Operative Pain, run by University of Baghdad at 1 site in Iraq.
Trial summary
1. To compare the postoperative pain between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day. 2. To compare the postoperative swelling (edema) between the patients who receive the systemic enzyme therapy and patients in the control group in the third… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- systemic proteolytic enzyme (Tibrolin) and Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteIraq
- Study dates
- 8 May 2024to 9 Sep 2024
- Phase
- Phase 3
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy patients over 18 years old of either gender.
- Patients who have impacted mandibular third molar.
- Ability to tolerate surgical procedure.
- Pell and Gregory's classification (Class I and class II, position A and B).
Who cannot join
- Patients with uncontrolled systemic diseases.
- Patients with history of chemotherapy or radiotherapy therapy to the head and neck region.
- Acute infection at the surgical site at time of operation.
- The presence of cysts or tumors associated with the impacted teeth.
- Pell and Gregory's classification (class III Position C)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and Quality of Life After Surgical Extraction of Impacted Mandibular Third Molars
- To compare the postoperative pain between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
- To compare the postoperative swelling (edema) between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
- To compare the degree of trismus between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
- Measure patients' perceptions of changes in their quality of life in the postoperative period and compare it between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
Read the detailed description
Evaluation of the effect of systemic proteolytic enzyme therapy on postoperative inflammatory response and quality of life after surgical extraction of impacted mandibular third molar.
The aim of this study is to evaluate the effect of systemic enzyme therapy(TibrolinTM) on the postoperative inflammatory response and the quality of life after surgical removal of impacted third molar. The study is designed and was implemented as a randomized controlled clinical study guided by Consolidated Standards of Reporting Trials (CONSORT) guidelines . Patients were randomly allocated to two groups (25patients per group). Group A included administration of SET after surgery and continued for 5 days post-surgery; Group B, a control group that would not receive the systemic enzyme therapy . The predictor variable was The use of systemic proteolytic enzyme (Tibrolin) or not .The primary outcome variables were pain and swelling , trismus,quality of life measured on 1st day (day of surgery), third day, and 7th after surgery.
- Conditions
- Post Operative Pain
- Being tested
- systemic proteolytic enzyme (Tibrolin), Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg
- Keywords
- systemic proteolytic enzyme, pain, trismus, swelling, tibrolin
- Medical subject headings
- Pain, Postoperative, Pain, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systemic proteolytic enzyme (Tibrolin)Drug
Also called tibrolin
Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg)
Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mgDrug
Amoxicillin is given with metronidazole 500mg 1*3' Doliprane 1000mg is given 1*1
| Study group | Role | What they receive |
|---|---|---|
| systemic proteolytic enzyme | Active comparator | Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) one by one for five day Receives: Drug: systemic proteolytic enzyme (Tibrolin) |
| amoxicillin, metronidazol, doliprane | Placebo comparator | amoxicillin 500 mg one by three metronidazol 500 mg one by three doulprane 1000 mg one by one Receives: Drug: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after surgery
pain will be measured on pain rating scale form 0 to 10
Measured: 7 Days
Facial swelling
swelling will be determined by distance between 3 points
Measured: 7 Days
Trismus
the degree of trismus will be measured by maximum mouth opening
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start8 May 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion9 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mgand a bioflavonoid (Rutoside 100 mg) .one by one for five day
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dunya Abdulmuniem, University of Baghdad
- Investigators
- salwan bede, Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681312
- Sponsor's protocol ID
- 673122
- Status last verified
- May 2024
- First submitted
- 13 Dec 2022
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and Quality of Life After Surgical Extraction of Impacted Mandibular Third Molars
- ClinicalTrials.gov ID
- NCT05681312
- Acronym / sponsor ID
- 673122
- Conditions
- Post Operative Pain
- Keywords
- systemic proteolytic enzyme, pain, trismus, swelling, tibrolin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 8 May 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 9 Sep 2024 (estimated)
- First posted
- 12 Jan 2023 (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.
- To compare the postoperative pain between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
- To compare the postoperative swelling (edema) between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
- To compare the degree of trismus between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
- Measure patients' perceptions of changes in their quality of life in the postoperative period and compare it between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
Detailed description
Evaluation of the effect of systemic proteolytic enzyme therapy on postoperative inflammatory response and quality of life after surgical extraction of impacted mandibular third molar.
The aim of this study is to evaluate the effect of systemic enzyme therapy(TibrolinTM) on the postoperative inflammatory response and the quality of life after surgical removal of impacted third molar. The study is designed and was implemented as a randomized controlled clinical study guided by Consolidated Standards of Reporting Trials (CONSORT) guidelines . Patients were randomly allocated to two groups (25patients per group). Group A included administration of SET after surgery and continued for 5 days post-surgery; Group B, a control group that would not receive the systemic enzyme therapy . The predictor variable was The use of systemic proteolytic enzyme (Tibrolin) or not .The primary outcome variables were pain and swelling , trismus,quality of life measured on 1st day (day of surgery), third day, and 7th after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mgand a bioflavonoid (Rutoside 100 mg) .one by one for five day
| Arm | Type | Receives |
|---|---|---|
| systemic proteolytic enzyme | Active comparator | Drug: systemic proteolytic enzyme (Tibrolin)Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) one by one for five day |
| amoxicillin, metronidazol, doliprane | Placebo comparator | Drug: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mgamoxicillin 500 mg one by three metronidazol 500 mg one by three doulprane 1000 mg one by one |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy patients over 18 years old of either gender.
- Patients who have impacted mandibular third molar.
- Ability to tolerate surgical procedure.
- Pell and Gregory's classification (Class I and class II, position A and B).
Key exclusion criteria (5 listed)
- Patients with uncontrolled systemic diseases.
- Patients with history of chemotherapy or radiotherapy therapy to the head and neck region.
- Acute infection at the surgical site at time of operation.
- The presence of cysts or tumors associated with the impacted teeth.
- Pell and Gregory's classification (class III Position C)
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 |
|---|---|---|
| systemic proteolytic enzyme (Tibrolin)Also: tibrolinTibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) | Drug | systemic proteolytic enzyme |
| Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mgAmoxicillin is given with metronidazole 500mg 1*3' Doliprane 1000mg is given 1*1 | Drug | amoxicillin, metronidazol, doliprane |
Primary outcome
Pain after surgery
Time frame: 7 Days
pain will be measured on pain rating scale form 0 to 10
Facial swelling
Time frame: 7 Days
swelling will be determined by distance between 3 points
Trismus
Time frame: 7 Days
the degree of trismus will be measured by maximum mouth opening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
salwan bede study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing systemic proteolytic enzyme (Tibrolin) and Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg in people with Post Operative Pain, run by University of Baghdad at 1 site in Iraq.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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 Iraq. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dunya Abdulmuniem (078018282446 ext. 00964, duniamuniem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after surgery (time frame: 7 Days). The study lists 3 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 8 May 2024.