Ent Clinic ASST Settelaghi, University of Insubriae
Varese, Italy
NCT Number: NCT07198607
This retrospective, observational, case-control clinical study evaluated the safety and efficacy of nasal drops containing Pistacia lentiscus oil in preventing recurrence of chronic rhinosinusitis during long-term therapy. Adult patients with chronic rhinosinusitis who received isotonic saline wash plus Pistacia lentiscus oil drops were retrospectively compared with patients who received isotonic saline wash alone, with a total treatment duration of 12 months. The primary outcome was change in Sino-Nasal Outcome Test-22 (SNOT-22) scores, while secondary outcomes included ciliary motility, nasal secretion, biofilm presence, cytological changes, adverse events, and safety/tolerability.
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Notify Me18 year and older
All sexes
Observational
Varese, Italy
Chronic rhinosinusitis (CRS) is a common and recurrent condition associated with significant morbidity and impaired quality of life. Standard treatment approaches often provide only partial or temporary relief, and recurrence rates remain high. Pistacia lentiscus oil has demonstrated anti-inflammatory and mucosal protective properties, supporting its potential role as a preventive tool in CRS management.
This monocenter, non-profit, retrospective observational case-control clinical study was conducted to evaluate the long-term preventive effect of Pistacia lentiscus oil nasal drops on CRS recurrence. One hundred patients aged ≥18 years with diagnosed CRS were retrospectively evaluated and compared between patients receiving isotonic saline wash plus Pistacia lentiscus oil drops (5 drops per nostril twice daily for 30 days, followed by maintenance treatment for 15 days per month over 11 months) and patients receiving isotonic saline wash alone on the same schedule.
The primary endpoint was the change in disease-specific quality of life, measured by the Sino-Nasal Outcome Test-22 (SNOT-22) from baseline to 12 months. Secondary endpoints included assessments of ciliary motility, nasal secretion, presence of biofilm, supranuclear striae, bacterial cells, variations in inflammatory cellularity (neutrophils, eosinophils, mast cells), safety, and tolerability.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bactorinol® nasal drops (medical device containing ultra-fractioned and winterized Pistacia lentiscus oil). Participants received isotonic saline nasal wash plus 5 drops per nostril twice daily for 30 days, followed by 5 drops per nostril twice daily for 15 days per month for the subsequent 11 months.
Other names: Winterized Pistacia lentiscus oil; Bactorinol®
Participants received isotonic saline nasal wash alone according to the same administration schedule used in the comparison group.
Time frame: Baseline, 1 month, and 1 year
The SNOT-22 questionnaire measures disease-specific quality of life in chronic rhinosinusitis patients. Scores range from 0 (no symptoms) to 110 (worst symptoms).
Time frame: Baseline, 1 month, and 1 year
Assessment of ciliary beat frequency and duration using phase contrast optical microscopy; considered normal if beating lasts >10 minutes.
Time frame: Baseline, 1 month, and 1 year
Presence or absence of nasal secretion, assessed by anterior rhinoscopy.
Time frame: Baseline, 1 month, and 1 year
Nasal secretion characteristics (clear, mucopurulent, or purulent) will be graded by anterior rhinoscopy using standardized clinical evaluation.
Time frame: Baseline, 1 month, and 1 year
Cytological evaluation of mucosal samples stained for biofilm, identified by cyan-colored areas.
Time frame: Baseline, 1 month, and 1 year
Microscopic evaluation of nasal mucosa samples for supranuclear striae.
Time frame: Baseline, 1 month, and 1 year
Cytological evaluation of mucosal samples for bacterial cells.
Time frame: Baseline, 1 month, and 1 year
Quantitative cytology of neutrophils, eosinophils, and mast cells from nasal mucosa samples.
Time frame: Throughout study period (up to1 year)
Safety will be assessed by recording all adverse events (local and systemic) related to nasal drop use, as evaluated by the investigator.
Time frame: Baseline, 1 month, and 1 year
Local tolerability will be assessed by anterior rhinoscopy for signs of nasal irritation (redness, swelling, mucosal damage) and patient-reported nasal discomfort using a Visual Analogue Scale (0-10).
Liaquat University of Medical & Health Sciences
Other
The Role of Pistacia Lentiscus Oil in the Prevention of Chronic Rhinosinusitis Recurrence During Long-Term Therapy: A Retrospective Observational Case-Control Study
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