Inflammation, Swelling, Trismus
Conditions
Brief 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.
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.
Interventions
DRUGSerodase 5 mg
Serodase 5mg two tablets three times per day
DRUGPlacebo
Placebo two tablets three times per day
Sponsors
Hayat Pharmaceutical Co. PLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trimus by measuring the interincisal distance | 5 days | the increase in the interincisal distance will show a positive effect on the Trismus |
| Swelling by using The Laskin method | 5 days | the decrease in swelling will shows a positive effect on swelling based distances at predetermined time points . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 5 days | pain will be measured using the numerical pain scale from (0-10) after surgery. |
Outcome results
None listed