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Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and QoL After Surgical Extraction of Impacted Mandibular Third Molars

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Phase 3
Locations
Iraq
Study Type
Interventional
Intervention
systemic proteolytic enzyme (Tibrolin)
Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring systemic proteolytic enzyme, pain, trismus, swelling, tibrolin

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Healthy patients over 18 years old of either gender. Patients who have impacted mandibular third molar. Ability to tolerate surgical procedure. Pell and Gregory's classification (Class I and class II, position A and B). Exclusion Criteria: Patients with uncontrolled systemic diseases. Patients with history of chemotherapy or radiotherapy therapy to the head and neck region. Acute infection at the surgical site at time of operation. The presence of cysts or tumors associated with the impacted teeth. Pell and Gregory's classification (class III Position C)

Sites / Locations

  • Dunya Abdulmuniem MahmoodRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

systemic proteolytic enzyme

amoxicillin, metronidazol, doliprane

Arm Description

Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) one by one for five day

amoxicillin 500 mg one by three metronidazol 500 mg one by three doulprane 1000 mg one by one

Outcomes

Primary Outcome Measures

Pain after surgery
pain will be measured on pain rating scale form 0 to 10
Facial swelling
swelling will be determined by distance between 3 points
Trismus
the degree of trismus will be measured by maximum mouth opening

Secondary Outcome Measures

Full Information

First Posted
December 13, 2022
Last Updated
August 18, 2023
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05681312
Brief Title
Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and QoL After Surgical Extraction of Impacted Mandibular Third Molars
Official Title
Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and Quality of Life After Surgical Extraction of Impacted Mandibular Third Molars
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To compare the postoperative pain between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day. To compare the postoperative swelling (edema) between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day. To compare the degree of trismus between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day. Measure patients' perceptions of changes in their quality of life in the postoperative period and compare it between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
Detailed Description
Evaluation of the effect of systemic proteolytic enzyme therapy on postoperative inflammatory response and quality of life after surgical extraction of impacted mandibular third molar. The aim of this study is to evaluate the effect of systemic enzyme therapy(TibrolinTM) on the postoperative inflammatory response and the quality of life after surgical removal of impacted third molar. The study is designed and was implemented as a randomized controlled clinical study guided by Consolidated Standards of Reporting Trials (CONSORT) guidelines . Patients were randomly allocated to two groups (25patients per group). Group A included administration of SET after surgery and continued for 5 days post-surgery; Group B, a control group that would not receive the systemic enzyme therapy . The predictor variable was The use of systemic proteolytic enzyme (Tibrolin) or not .The primary outcome variables were pain and swelling , trismus,quality of life measured on 1st day (day of surgery), third day, and 7th after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
systemic proteolytic enzyme, pain, trismus, swelling, tibrolin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mgand a bioflavonoid (Rutoside 100 mg) .one by one for five day
Masking
Participant
Masking Description
metronidazol 500 mg 1bythree amoxicillin 500 mg 1by three doulprane 1000 mg one by one
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
systemic proteolytic enzyme
Arm Type
Active Comparator
Arm Description
Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) one by one for five day
Arm Title
amoxicillin, metronidazol, doliprane
Arm Type
Placebo Comparator
Arm Description
amoxicillin 500 mg one by three metronidazol 500 mg one by three doulprane 1000 mg one by one
Intervention Type
Drug
Intervention Name(s)
systemic proteolytic enzyme (Tibrolin)
Other Intervention Name(s)
tibrolin
Intervention Description
Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg)
Intervention Type
Drug
Intervention Name(s)
Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg
Intervention Description
Amoxicillin is given with metronidazole 500mg 1*3' Doliprane 1000mg is given 1*1
Primary Outcome Measure Information:
Title
Pain after surgery
Description
pain will be measured on pain rating scale form 0 to 10
Time Frame
7 Days
Title
Facial swelling
Description
swelling will be determined by distance between 3 points
Time Frame
7 Days
Title
Trismus
Description
the degree of trismus will be measured by maximum mouth opening
Time Frame
7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy patients over 18 years old of either gender. Patients who have impacted mandibular third molar. Ability to tolerate surgical procedure. Pell and Gregory's classification (Class I and class II, position A and B). Exclusion Criteria: Patients with uncontrolled systemic diseases. Patients with history of chemotherapy or radiotherapy therapy to the head and neck region. Acute infection at the surgical site at time of operation. The presence of cysts or tumors associated with the impacted teeth. Pell and Gregory's classification (class III Position C)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dunya Abdulmuniem
Phone
078018282446
Ext
00964
Email
duniamuniem@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
salwan bede
Organizational Affiliation
University of Baghdad
Official's Role
Study Director
Facility Information:
Facility Name
Dunya Abdulmuniem Mahmood
City
Baghdad
ZIP/Postal Code
10011
Country
Iraq
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and QoL After Surgical Extraction of Impacted Mandibular Third Molars

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