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

University of Baghdad

Status and phase: Enrolling; Phase 3

Conditions: Post Operative Pain

Treatments: Drug: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg; Drug: systemic proteolytic enzyme (Tibrolin)

Study type: Interventional

Funder types: Other

Identifiers

NCT05681312

673122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

55 participants in 2 patient groups, including a placebo group

systemic proteolytic enzyme

Active Comparator group

Description:

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

Treatment:

Drug: systemic proteolytic enzyme (Tibrolin)

amoxicillin, metronidazol, doliprane

Placebo Comparator group

Description:

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

Treatment:

Drug: Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg