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

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05681312
• Other study ID #: 673122
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: August 2023
• Source: University of Baghdad
• Contact: Dunya Abdulmuniem
• Phone: 078018282446
• Email: duniamuniem[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: January 1, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• systemic proteolytic enzyme (Tibrolin)
Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg)
• Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg
Amoxicillin is given with metronidazole 500mg 1*3' Doliprane 1000mg is given 1*1

Locations

Country	Name	City	State
Iraq	Dunya Abdulmuniem Mahmood	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

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