Efficacy Evaluation of the (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
Primary Purpose
Trismus, Swelling, Inflammation
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Serodase 5 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Trismus
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Serodase 5 mg
Placebo
Arm Description
Serodase ( Serratiopeptidase) 5 mg
Placebo
Outcomes
Primary Outcome Measures
Trimus by measuring the interincisal distance
the increase in the interincisal distance will show a positive effect on the Trismus
Swelling by using The Laskin method
the decrease in swelling will shows a positive effect on swelling based distances at predetermined time points .
Secondary Outcome Measures
Post-operative pain
pain will be measured using the numerical pain scale from (0-10) after surgery.
Full Information
NCT ID
NCT02493179
First Posted
April 6, 2015
Last Updated
July 6, 2015
Sponsor
Hayat Pharmaceutical Co. PLC
1. Study Identification
Unique Protocol Identification Number
NCT02493179
Brief Title
Efficacy Evaluation of the (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
Official Title
Efficacy Evaluation of the Dose Regimen of Serratiopeptidase (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hayat Pharmaceutical Co. PLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trismus, Swelling, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Serodase 5 mg
Arm Type
Active Comparator
Arm Description
Serodase ( Serratiopeptidase) 5 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Serodase 5 mg
Other Intervention Name(s)
Serratiopeptidase 5 mg tablets
Intervention Description
Serodase 5mg two tablets three times per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo tablets
Intervention Description
Placebo two tablets three times per day
Primary Outcome Measure Information:
Title
Trimus by measuring the interincisal distance
Description
the increase in the interincisal distance will show a positive effect on the Trismus
Time Frame
5 days
Title
Swelling by using The Laskin method
Description
the decrease in swelling will shows a positive effect on swelling based distances at predetermined time points .
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Post-operative pain
Description
pain will be measured using the numerical pain scale from (0-10) after surgery.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
33653320
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy Evaluation of the (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
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