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

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ClinicalTrials.gov Identifier: NCT02493179
Recruitment Status : Unknown
Verified July 2015 by Hayat Pharmaceutical Co. PLC.
Recruitment status was:  Not yet recruiting
First Posted : July 9, 2015
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Trismus Swelling Inflammation Drug: Serodase 5 mg Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy Evaluation of the Dose Regimen of Serratiopeptidase (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
Study Start Date : June 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : February 2016

Arm Intervention/treatment
Active Comparator: Serodase 5 mg
Serodase ( Serratiopeptidase) 5 mg
Drug: Serodase 5 mg
Serodase 5mg two tablets three times per day
Other Name: Serratiopeptidase 5 mg tablets

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo two tablets three times per day
Other Name: Placebo tablets




Primary Outcome Measures :
  1. Trimus by measuring the interincisal distance [ Time Frame: 5 days ]
    the increase in the interincisal distance will show a positive effect on the Trismus

  2. Swelling by using The Laskin method [ Time Frame: 5 days ]
    the decrease in swelling will shows a positive effect on swelling based distances at predetermined time points .


Secondary Outcome Measures :
  1. Post-operative pain [ Time Frame: 5 days ]
    pain will be measured using the numerical pain scale from (0-10) after surgery.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Responsible Party: Hayat Pharmaceutical Co. PLC
ClinicalTrials.gov Identifier: NCT02493179     History of Changes
Other Study ID Numbers: Ser.01
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Trismus
Inflammation
Pathologic Processes
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Serratiopeptidase
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents