Clinical trial NCT05681312: Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and QoL After Surgical Extraction of Impacted Mandibular Third Molars
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Post Operative Pain
Keywords: systemic proteolytic enzyme
pain
trismus
swelling
tibrolin
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mgand a bioflavonoid (Rutoside 100 mg) .one by one for five day
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain after surgery
timeFrame: 7 Days
measure: Facial swelling
timeFrame: 7 Days
measure: Trismus
timeFrame: 7 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Dunya Abdulmuniem Mahmood
Study officials:
affiliation: University of Baghdad
name: salwan bede
role: STUDY_DIRECTOR
References: