Effect of enzyme therapy on pain and recovery after wisdom tooth surgery
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
This study is testing if a new enzyme treatment can help people recover faster and feel less pain after having their wisdom teeth removed.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Baghdad Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Baghdad) |
| Trial ID | NCT05681312 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of systemic proteolytic enzyme therapy (Tibrolin) on postoperative pain, swelling, trismus, and quality of life in patients undergoing surgical extraction of impacted mandibular third molars. Patients are randomly assigned to receive either the enzyme therapy or standard care, with outcomes measured on the day of surgery, and on the third and seventh days post-surgery. The study aims to determine if enzyme therapy can improve recovery and reduce inflammation compared to a control group.
Who should consider this trial
Good fit: Ideal candidates are healthy adults over 18 years old with impacted mandibular third molars.
Not a fit: Patients with uncontrolled systemic diseases or those with a history of head and neck chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce postoperative pain and improve recovery quality for patients undergoing wisdom tooth extraction.
How similar studies have performed: Other studies have shown promising results with systemic enzyme therapies in reducing postoperative inflammation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Baghdad
- Dunya Abdulmuniem Mahmood — Baghdad, Iraq (Recruiting)
Study contacts
- Study coordinator: Dunya Abdulmuniem
- Email: duniamuniem@gmail.com
- Phone: 078018282446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.