Efficacy Evaluation of the (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy Evaluation of the Dose Regimen of Serratiopeptidase (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery

Conditions
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Trismus, Swelling, Inflammation

Intervention / Treatment
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* Drug: Serodase 5 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants presented with impacted lower wisdom tooth needs Buccaneers flap with buccal and distal bone removal. male or female 18-50 participant is willing and able to give informed consent for paricipation in the study. Able and willing and able with all study requirments. Exclusion Criteria: other oral surgical procedures during the same session except the removal of supernumerary third molars. female subject who is pregnant or lactating subjects has participated in any clinical research study within the previous 8 weeks. subjects on anti coagulant drugs . Unwilling participants to continue the study and those with abnormality of wound healing process.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Serodase 5 mg<br>Serodase ( Serratiopeptidase) 5 mg | Drug: Serodase 5 mg<br>* Serodase 5mg two tablets three times per day<br>* Other names: Serratiopeptidase 5 mg tablets;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo two tablets three times per day<br>* Other names: Placebo tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | pain will be measured using the numerical pain scale from (0-10) after surgery. | 5 days |