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Recruiting Phase 3 NCT05681312

Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and QoL After Surgical Extraction of Impacted Mandibular Third Molars

Trial Parameters

Condition Post Operative Pain
Sponsor University of Baghdad
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 55
Sex ALL
Min Age 18 Years
Max Age 40 Years
Start Date 2024-05-08
Completion 2024-09-01
Interventions
systemic proteolytic enzyme (Tibrolin)Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg

Brief 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 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.

Eligibility Criteria

Inclusion Criteria: * 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). Exclusion Criteria: * 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)

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