Study on the efficacy of a food supplement, in the form of chewing gum, based on extracts of Scutellaria lateriflora L. and Cistus x incanus L., in adults who have gingivitis as a risk factor for periodontitis, on the symptoms associated with this condition: placebo-controlled, single-centre clinical study, randomized, in parallel groups, double-blind

Epo S.r.l.0 个研究点目标入组 60 人开始时间: 2023年8月9日最近更新: 2024年4月8日

适应症

试验速览

2024 Results article in https://doi.org/10.3390/nu16060862 (added 28/03/2024)

•1. Aged 18-70 years of both sexes
•2. Able to understand and sign informed consent
•3. Have symptomatic gingivitis
•4. Absence of diagnosed periodontitis or loss of teeth caused by periodontal disease
•5. Cut-off value for QGBI index score =1
•6. Cut-off value for MGI index score =1
•7. Score >2 on the question Did you have gum bleeding problems? in completing the questionnaire OH-15
•8. At least 20 teeth for people older than 60 years

•1. Aged <18 and >70 years
•2. Have a medical history or condition that could affect the subject's safety or negatively impact the validity of the study results
•3. Pregnant or breastfeeding women
•4. Cognitive impairments which could hinder the response to questionnaires
•5. History of allergy to ingredients contained in the study treatments (dietary supplement and placebo)
•6. Suffering from periodontitis
•7. Suffering from pathologies of the oral cavity (tongue cancer, glossitis, dry mouth)
•8. Have undergone dental cleaning or scaling within 2 months of enrollment
•9. Have undergone antibiotic therapy within 2 months of enrollment
•10. Current use or in the week preceding the recruitment of prescription or over-the-counter drugs, which may affect inflammatory levels (NSAIDs and others)
•11. History of addiction or abuse of drugs, drugs, or alcohol
•12. Heavy smokers (> 10 cigarettes/day)
•13. Genetic-metabolic diseases
•14. Diabetes
•15. Rheumatic disorders
•16. Neuropsychiatric/neurologic disorders

发起方

Epo S.r.l.