Using a special gel to improve recovery after wisdom tooth extraction
Effects of the Application of a Hyper-oxygenated Gel After Extraction of Impacted Lower Third Molars: Randomized Controlled Study
This study is testing whether a special gel can help people recover better after having their wisdom teeth removed by reducing pain and swelling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera di Perugia Academic / other |
| Locations | 1 site (Perugia) |
| Trial ID | NCT06458478 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of a hyper-oxygenated gel, Novox®, applied to surgical wounds following the extraction of lower third molars. The study will compare outcomes such as pain, facial swelling, and muscle spasms in patients using the gel versus those receiving a placebo. Participants will be randomly assigned to one of two groups, with the trial conducted at a maxillofacial surgery clinic starting in July 2024. The gel is designed to enhance healing by promoting microcirculation and preventing infection.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18 to 35 who require extraction of impacted lower third molars.
Not a fit: Patients with systemic health issues such as diabetes, hypertension, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce post-operative pain and swelling for patients undergoing wisdom tooth extraction.
How similar studies have performed: While similar approaches have been explored, the specific use of this hyper-oxygenated gel in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * good systemic and local health conditions of the patient; * age between 18 and 35 years; * understanding of the Italian language, * indications for the extraction of impacted bilateral lower third molars (38 and 48) according to the criteria reported in the classifications of Winter and that of Pell and Gregory; * the root of the impacted third molars is completely formed. Exclusion Criteria: * diabetes mellitus; * systemic arterial hypertension; * hyperthyroidism; * osteoporosis; * immunosuppressed; * osteonecrosis of the jaws; * pregnancy; * patients with mandibular third molars in position C according to "the Pell \& Gregory Classification" on the radiological measurements (angles and positions) for which third molar extraction surgery is required.; * local alterations such as pericoronitis, odontogenic cysts and tumors in relation to the third molars; * allergies; * ordinary use of analgesics or antibiotics by the patient.
Where this trial is running
Perugia
- Ospedale Santa Maria della Misericordia — Perugia, Italy (Recruiting)
Study contacts
- Principal investigator: Massimiliano Gilli, Dr — Azienda Ospedaliera Perugia
- Study coordinator: valeria mitro, Dr
- Email: valeria.mitro@ospedale.perugia.it
- Phone: +393494509722
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.