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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
55
Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg)
Amoxicillin is given with metronidazole 500mg 1\*3' Doliprane 1000mg is given 1\*1
Dunya Abdulmuniem Mahmood
Baghdad, Iraq
RECRUITINGPain after surgery
pain will be measured on pain rating scale form 0 to 10
Time frame: 7 Days
Facial swelling
swelling will be determined by distance between 3 points
Time frame: 7 Days
Trismus
the degree of trismus will be measured by maximum mouth opening
Time frame: 7 Days
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