RecruitingPhase 3NCT05681312

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


Sponsor

University of Baghdad

Enrollment

55 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a systemic enzyme therapy (a supplement containing natural enzymes) can reduce inflammation, swelling, and pain after the surgical removal of an impacted lower wisdom tooth — and whether it improves recovery and quality of life afterward. **You may be eligible if...** - You are a healthy adult (18 or older) - You have an impacted lower wisdom tooth that needs to be surgically removed - Your impacted tooth is classified as moderately to partially impacted (Pell and Gregory Class I or II, Position A or B) - You are healthy enough to tolerate the surgery **You may NOT be eligible if...** - You have uncontrolled systemic diseases - You have had chemotherapy or radiation to the head/neck region - You have an active infection at the surgery site - Your wisdom tooth is associated with a cyst or tumor - Your tooth is fully or deeply impacted (Pell and Gregory Class III, Position C) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsystemic proteolytic enzyme (Tibrolin)

Tibrolin is a fixed dose combination of(Trypsin 48 mg, Bromelain 90 mg) and a bioflavonoid (Rutoside 100 mg)

DRUGAmoxicillin 500mg+metronidazole 500mg+ doliprane 100mg

Amoxicillin is given with metronidazole 500mg 1\*3' Doliprane 1000mg is given 1\*1


Locations(1)

Dunya Abdulmuniem Mahmood

Baghdad, Iraq

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NCT05681312


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