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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
Hayat Pharmaceutical Co. PLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trismus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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.

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

    First Posted
    April 6, 2015
    Last Updated
    July 6, 2015
    Sponsor
    Hayat Pharmaceutical Co. PLC
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    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

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    Efficacy Evaluation of the (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery

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