Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and QoL After Surgical Extraction of Impacted Mandibular Third Molars
NCT ID: NCT05681312
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
55 participants
INTERVENTIONAL
2024-05-08
2024-09-09
Brief Summary
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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 and seventh day.
3. 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.
4. 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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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systemic proteolytic enzyme
Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) one by one for five day
systemic proteolytic enzyme (Tibrolin)
Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg)
amoxicillin, metronidazol, doliprane
amoxicillin 500 mg one by three metronidazol 500 mg one by three doulprane 1000 mg one by one
Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg
Amoxicillin is given with metronidazole 500mg 1\*3' Doliprane 1000mg is given 1\*1
Interventions
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systemic proteolytic enzyme (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 100mg
Amoxicillin is given with metronidazole 500mg 1\*3' Doliprane 1000mg is given 1\*1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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)
18 Years
40 Years
ALL
No
Sponsors
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University of Baghdad
OTHER
Responsible Party
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Dunya Abdulmuniem
Principal investigator
Principal Investigators
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salwan bede
Role: STUDY_DIRECTOR
University of Baghdad
Locations
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Dunya Abdulmuniem Mahmood
Baghdad, , Iraq
Countries
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Central Contacts
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Other Identifiers
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673122
Identifier Type: -
Identifier Source: org_study_id
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