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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| systemic proteolytic enzyme | Active Comparator | Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) one by one for five day |
|
| amoxicillin, metronidazol, doliprane | Placebo Comparator | amoxicillin 500 mg one by three metronidazol 500 mg one by three doulprane 1000 mg one by one |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| systemic proteolytic enzyme (Tibrolin) | Drug | Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dunya Abdulmuniem | Contact | 078018282446 | 00964 | duniamuniem@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| salwan bede | University of Baghdad | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dunya Abdulmuniem Mahmood | Recruiting | Baghdad | 10011 | Iraq |
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Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mgand a bioflavonoid (Rutoside 100 mg) .one by one for five day
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metronidazol 500 mg 1bythree amoxicillin 500 mg 1by three doulprane 1000 mg one by one
|
| Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg | Drug | Amoxicillin is given with metronidazole 500mg 1*3' Doliprane 1000mg is given 1*1 |
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D014313 | Trismus |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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