TrismusPhase 4NCT02493179
Efficacy Evaluation of the (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
A Phase 4 study testing Serodase 5 mg in people with Trismus and Swelling, run by Hayat Pharmaceutical Co. PLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Trismus, Swelling, Inflammation
- What is being tested?
- Serodase 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Efficacy Evaluation of the Dose Regimen of Serratiopeptidase (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
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.
Read the 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.
- Conditions
- Trismus, Swelling, Inflammation
- Being tested
- Serodase 5 mg, Placebo
- Medical subject headings
- Trismus, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serodase 5 mgDrug
Also called Serratiopeptidase 5 mg tablets
Serodase 5mg two tablets three times per day
PlaceboDrug
Also called Placebo tablets
Placebo two tablets three times per day
| Study group | Role | What they receive |
|---|---|---|
| Serodase 5 mg | Active comparator | Serodase ( Serratiopeptidase) 5 mg Receives: Drug: Serodase 5 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trimus by measuring the interincisal distance
the increase in the interincisal distance will show a positive effect on the Trismus
Measured: 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 .
Measured: 5 days
Secondary outcomes (1)
Post-operative pain
pain will be measured using the numerical pain scale from (0-10) after surgery.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TrismusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayat Pharmaceutical Co. PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493179
- Sponsor's protocol ID
- Ser.01
- Status last verified
- Jul 2015
- First submitted
- 6 Apr 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33653320
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of the Dose Regimen of Serratiopeptidase (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
- ClinicalTrials.gov ID
- NCT02493179
- Acronym / sponsor ID
- Ser.01
- Conditions
- Trismus, Swelling, Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Hayat Pharmaceutical Co. PLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serodase 5 mg | Active comparator | Drug: Serodase 5 mgSerodase ( Serratiopeptidase) 5 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serodase 5 mgAlso: Serratiopeptidase 5 mg tabletsSerodase 5mg two tablets three times per day | Drug | Serodase 5 mg |
| PlaceboAlso: Placebo tabletsPlacebo two tablets three times per day | Drug | Placebo |
Primary outcome
Trimus by measuring the interincisal distance
Time frame: 5 days
the increase in the interincisal distance will show a positive effect on the Trismus
Swelling by using The Laskin method
Time frame: 5 days
the decrease in swelling will shows a positive effect on swelling based distances at predetermined time points .
1 secondary outcome
Post-operative pain
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
- Derived from this study: PubMed 33653320Tamimi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Serodase 5 mg in people with Trismus and Swelling, run by Hayat Pharmaceutical Co. PLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trimus by measuring the interincisal distance (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02493179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.