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

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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Trismus; Swelling
• Intervention / Treatment: Drug: Serodase 5 mg; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo two tablets three times per day; Other Names: Placebo tablets
Active Comparator: Serodase 5 mg; Serodase ( Serratiopeptidase) 5 mg	Drug: Serodase 5 mg; Serodase 5mg two tablets three times per day; Other Names: Serratiopeptidase 5 mg tablets

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hayat Pharmaceutical Co. PLC

Publications and helpful links

General Publications

• Tamimi Z, Al Habashneh R, Hamad I, Al-Ghazawi M, Roqa'a AA, Kharashgeh H. Efficacy of serratiopeptidase after impacted third molar surgery: a randomized controlled clinical trial. BMC Oral Health. 2021 Mar 2;21(1):91. doi: 10.1186/s12903-021-01451-0.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: April 6, 2015
• First Submitted That Met QC Criteria: July 6, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Estimate): July 9, 2015
• Last Update Submitted That Met QC Criteria: July 6, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Spasm; Inflammation; Trismus; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Serratiopeptidase
• Other Study ID Numbers: Ser.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No