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

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

1. 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.
2. 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.
3. 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.
4. 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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: systemic proteolytic enzyme (Tibrolin); Drug: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg

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.

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dunya Abdulmuniem; Phone Number: 00964 078018282446; Email: duniamuniem@gmail.com

Study Locations

• Iraq
  • Baghdad, Iraq, 10011
    • Recruiting
    • Dunya Abdulmuniem Mahmood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: systemic proteolytic enzyme; Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg) one by one for five day	Drug: systemic proteolytic enzyme (Tibrolin); Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg); Other Names: tibrolin
Placebo Comparator: amoxicillin, metronidazol, doliprane; amoxicillin 500 mg one by three metronidazol 500 mg one by three doulprane 1000 mg one by one	Drug: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg; Amoxicillin is given with metronidazole 500mg 1*3' Doliprane 1000mg is given 1*1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after surgery	pain will be measured on pain rating scale form 0 to 10	7 Days
Facial swelling	swelling will be determined by distance between 3 points	7 Days
Trismus	the degree of trismus will be measured by maximum mouth opening	7 Days

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Study Director: salwan bede, University of Baghdad

Study record dates

Study Major Dates

• Study Start (Estimated): May 8, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 9, 2024

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: pain; trismus; swelling; systemic proteolytic enzyme; tibrolin
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Amoxicillin
• Other Study ID Numbers: 673122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No