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.