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

NCT05681312 | Recruiting Phase 3

• 1 other identifier: 673122
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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. 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.

Conditions

Post Operative Pain

Keywords

systemic proteolytic enzyme; pain; trismus; swelling; tibrolin

Outcome Measures

Primary Outcomes (3)

• Pain after surgery

  pain will be measured on pain rating scale form 0 to 10

  7 Days

• Facial swelling

  swelling will be determined by distance between 3 points

  7 Days

• Trismus

  the degree of trismus will be measured by maximum mouth opening

  7 Days

Study Arms (2)

systemic proteolytic enzyme

ACTIVE COMPARATOR

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

Drug: systemic proteolytic enzyme (Tibrolin)

amoxicillin, metronidazol, doliprane

PLACEBO COMPARATOR

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

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

Interventions

systemic proteolytic enzyme (Tibrolin) DRUG

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

Also known as: tibrolin

systemic proteolytic enzyme

Amoxicillin 500mg+metronidazole 500mg+ doliprane 100mg DRUG

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

amoxicillin, metronidazol, doliprane

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Dunya Abdulmuniem Mahmood

Baghdad, 10011, Iraq

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Pain; Trismus

Interventions

Amoxicillin; Metronidazole

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• salwan bede

  University of Baghdad

  STUDY DIRECTOR

Central Study Contacts

Dunya Abdulmuniem

CONTACT

078018282446; duniamuniem@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: metronidazol 500 mg 1bythree amoxicillin 500 mg 1by three doulprane 1000 mg one by one
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Tibrolin combination of (Trypsin 48 mg, Bromelain 90 mgand a bioflavonoid (Rutoside 100 mg) .one by one for five day

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 12, 2023
• Study Start: May 8, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 9, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

IR (1)