Assessment of Locked Nose Improvement in patients who received a Nasal Implant
- Conditions
- Other specified disorders of the nose and paranasal sinuses
- Registration Number
- RBR-34tv3fz
- Lead Sponsor
- Pontifícia Universidade Católica do Paraná
- Brief Summary
Introduction: Nasal valve dysfunction is one of the main structural causes of nasal obstruction. Objective: To clinically test a bioabsorbable nasal implant in the treatment of nasal obstruction caused by nasal valve insufficiency. Materials and Methods: A double-blind randomized clinical trial was carried out to test the functionality of the implant with 12 participants divided into an implanted group A (n = 6) and a control group B (n = 6). The patients underwent clinical examinations and assessment using NOSE, Visual Analog and Ottawa scales immediately after the intervention and after 15, 30, 90 and 180 days. Statistical analyzes of clinical outcomes and a satisfaction survey through a questionnaire were carried out. Results: According to the NOSE scale, group A showed improvement in nasal obstruction in 50% (p = 0.075) and group B in 16.7% (p = 0.083) of cases soon after the intervention. After 15 days, group A improved by 100% and group B maintained 16.7% (p = 0.083) of improvement. After 30 days, group A remained at 100% and group B increased the improvement to 33.3% (p = 0.273). In the evaluations after 90 and 180 days of the intervention, group A maintained the 100% improvement obtained and group B presented a 16.7% improvement (p = 0.083) of the obstruction. The mean differences in the Visual Analog Scale (VAS) between the initial visit and the other visits in group A (p = 0.006) were much higher than the mean differences in group B (= 1). It was observed that the greater the degree of severity in the NOSE scale, the greater the degree reported in the EVA. According to the OTTAWA scale, all participants in group A obtained an improvement in the degree of collapse of the nasal lateral wall compared to those in group B, who remained indifferent. Conclusions: Bioabsorbable poly(e-caprolactone) (PCL) implant proved to be safe and effective for 6 months in the treatment of nasal valve dysfunction, proving its functionality and can be considered as a new option in the treatment of nasal obstruction caused by insufficiency of the nasal valve.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Patients aged between 50 and 79 years; with insufficiency of the nasal lateral wall confirmed through the positive Modified Cottle maneuver; with severe or extreme nasal obstruction in the evaluation by the NOSE Scale (Nasal Obstruction Symptom Evaluation Scale) (score = 55); impossibility or refusal to perform functional rhinoplasty; and lack of significant improvement after clinical treatment for at least four continuous months.
Smoking patients; with decompensated chronic rhinitis; with nasosinusal polyposis; with nasal granulomatous diseases; with any inflammatory or infectious diseases or conditions in the nasal or facial region; with a history of nasal implants or some type of nasal filling; with immunosuppressive disease; with healing disorders; with uncontrolled systemic diseases such as diabetes or heart disease.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in nasal obstruction symptoms measured by the NOSE (Nose Obstruction Symptom Evaluation) and EVA (Visual Analog Scale) scales after 6 months of placement of a bioabsorbable nasal implant.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are not expected.