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

Inclusion Criteria4

  • 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 Criteria5

  • 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)

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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