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

Hayat Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Inflammation; Swelling; Trismus

Treatments: Drug: Serodase 5 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02493179

Ser.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 2 patient groups, including a placebo group

Serodase 5 mg

Active Comparator group

Description:

Serodase ( Serratiopeptidase) 5 mg

Treatment:

Drug: Serodase 5 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Sponsor of this trial

Lead Sponsor

Hayat Pharmaceutical