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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02493179
• Other study ID #: Ser.01
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 6, 2015
• Last updated: July 6, 2015
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: July 2015
• Source: Hayat Pharmaceutical Co. PLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Jordanian Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Swelling
• Trismus

Intervention

Drug:
• Serodase 5 mg
Serodase 5mg two tablets three times per day
• Placebo
Placebo two tablets three times per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hayat Pharmaceutical Co. PLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trimus by measuring the interincisal distance	the increase in the interincisal distance will show a positive effect on the Trismus	5 days	Yes
Primary	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	Yes
Secondary	Post-operative pain	pain will be measured using the numerical pain scale from (0-10) after surgery.	5 days	Yes