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

Phase 4

• Conditions: Swelling; Trismus; Inflammation
• Interventions: Drug: Placebo; Drug: Serodase 5 mg

• Registration Number: NCT02493179
• Lead Sponsor: Hayat Pharmaceutical Co. PLC

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-04-06
• Study Start: 2015-06
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-06
• Last Update Submitted: 2015-07-06
• Study First Posted: 2015-07-09
• Last Update Posted: 2015-07-09
• Primary Completion: 2016-01
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Serodase 5 mg	Serodase 5 mg	Serodase ( Serratiopeptidase) 5 mg

Primary Outcome Measures

Name	Time	Method
Trimus by measuring the interincisal distance	5 days	the increase in the interincisal distance will show a positive effect on the Trismus
Swelling by using The Laskin method	5 days	the decrease in swelling will shows a positive effect on swelling based distances at predetermined time points .

Secondary Outcome Measures

Name	Time	Method
Post-operative pain	5 days	pain will be measured using the numerical pain scale from (0-10) after surgery.