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

Last updated: July 6, 2015
Sponsor: Hayat Pharmaceutical Co. PLC
Overall Status: Trial Status Unknown

Phase

4

Condition

Inflammation

Treatment

N/A

Clinical Study ID

NCT02493179
Ser.01
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • participants presented with impacted lower wisdom tooth needs Buccaneers flap withbuccal and distal bone removal.

  • male or female 18-50

  • participant is willing and able to give informed consent for paricipation in thestudy.

  • Able and willing and able with all study requirments.

Exclusion

Exclusion Criteria:

  • other oral surgical procedures during the same session except the removal ofsupernumerary 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 woundhealing process.

Study Design

Total Participants: 112
Study Start date:
June 01, 2015
Estimated Completion Date:
February 29, 2016

Study 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.