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The purpose of this study is to examine the efficacy of dose regimen of serratiopeptidase (serodase 5 mg) as a prospective, randomized, parallel, double blind Placebo- controlled study.
A prospective, randomized, parallel, double blind Placebo- controlled study to examine the efficacy of dose regimen of serratiopeptidase (serodase 5 mg) on 112 males and females volunteers in the treatment of inflammation after third molar surgery, comparing drug treatment vs placebo over a period of 20 weeks To assess the dose effectiveness of the dose regimen of Serodase 5 mg; the primary outcomes are trismus and swelling while inflammation is a secondary outcome.the expected duration of participants participation will be around 5 days divided into 4 visits, the time point of the measurment are (0,2,4 and 5 days).
The results are expected to assess the improvement of the maximal interincisal distance, reduction of swelling and improvment in the sensation of post-operative pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serodase 5 mg | Active Comparator | Serodase ( Serratiopeptidase) 5 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serodase 5 mg | Drug | Serodase 5mg two tablets three times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trimus by measuring the interincisal distance | the increase in the interincisal distance will show a positive effect on the Trismus | 5 days |
| Swelling by using The Laskin method | the decrease in swelling will shows a positive effect on swelling based distances at predetermined time points . | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | pain will be measured using the numerical pain scale from (0-10) after surgery. | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33653320 | Derived | Tamimi Z, Al Habashneh R, Hamad I, Al-Ghazawi M, Roqa'a AA, Kharashgeh H. Efficacy of serratiopeptidase after impacted third molar surgery: a randomized controlled clinical trial. BMC Oral Health. 2021 Mar 2;21(1):91. doi: 10.1186/s12903-021-01451-0. |
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| ID | Term |
|---|---|
| D014313 | Trismus |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C022640 | serratiopeptidase |
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| Placebo | Drug | Placebo two tablets three times per day |
|
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |