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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: systemic proteolytic enzyme (Tibrolin)
* Drug: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mgand a bioflavonoid (Rutoside 100 mg) .one by one for five day
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: systemic proteolytic enzyme<br>Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) one by one for five day | Drug: systemic proteolytic enzyme (Tibrolin)<br>* Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg)<br>* Other names: tibrolin;|
| Placebo Comparator: amoxicillin, metronidazol, doliprane<br>amoxicillin 500 mg one by three metronidazol 500 mg one by three doulprane 1000 mg one by one | Drug: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg<br>* Amoxicillin is given with metronidazole 500mg 1*3' Doliprane 1000mg is given 1*1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after surgery | pain will be measured on pain rating scale form 0 to 10 | 7 Days | 
| Facial swelling | swelling will be determined by distance between 3 points | 7 Days | 
| Trismus | the degree of trismus will be measured by maximum mouth opening | 7 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic proteolytic enzyme, pain, trismus, swelling, tibrolin