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
1 other identifier
interventional
112
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2015
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJuly 9, 2015
July 1, 2015
7 months
April 6, 2015
July 6, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Post-operative pain
5 days
Study Arms (2)
Serodase 5 mg
ACTIVE COMPARATORSerodase ( Serratiopeptidase) 5 mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Serodase 5mg two tablets three times per day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33653320DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2015
First Posted
July 9, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2016
Study Completion
February 1, 2016
Last Updated
July 9, 2015
Record last verified: 2015-07