Clinical trial

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

Name

673122

Description

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.

Trial arms

Trial start

2024-05-08

Estimated PCD

2024-09-01

Trial end

2024-09-09

Status

Recruiting

Phase

Early phase I

Treatment

systemic proteolytic enzyme (Tibrolin)

Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg)

Arms:

systemic proteolytic enzyme

Other names:

tibrolin

Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg

Amoxicillin is given with metronidazole 500mg 1\*3' Doliprane 1000mg is given 1\*1

Arms:

amoxicillin, metronidazol, doliprane

Size

Primary endpoint

Pain after surgery

7 Days

Facial swelling

7 Days

Trismus

7 Days

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mgand a bioflavonoid (Rutoside 100 mg) .one by one for five day', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'metronidazol 500 mg 1bythree amoxicillin 500 mg 1by three doulprane 1000 mg one by one', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 55, 'type': 'ESTIMATED'}}

Updated at

2024-05-08

1 organization

Organization

University of Baghdad