Preventing periodontitis in individuals with symptomatic gingivitis Oral Health
Conditions
Interventions
Participants will consume a food supplement, in chewing gum form, based on Scutellaria lateriflora L. and Cistus x incanus L. extracts, or a placebo, for 90 days, based on the randomization group.
Th
after 60 days of treatment = t2
after 90 days of treatment = t3) in an outpatient setting. After each clinical visit, all data are filled in the CRF by physicians.
During the screening visit, subjects will undergo the following inv
Sponsors
Epo S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Aged 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gum health assessed using the Quantitative Gingival Bleeding Index (QGBI) at t0 (baseline), t1 (30 days of treatment), t2 (60 days of treatments), t3 (90 days of treatments) 2. Symptoms of discomfort at the level of the oral cavity in the 7 days prior to completion, assessed using Oral Health 15 items (OH-15) at t0 (baseline), t1 (30 days of treatment), t2 (60 days of treatments), t3 (90 days of treatments) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Oral microbiota composition assessed using next-generation sequencing (NGS) on saliva samples at t0 (baseline) and t3 (90 days of treatment). Ribosomal RNA 16 s (16s rRNA) analysis of oral microbial species and strains, through PCR. 2. Pain assessed using the Visual Analogue Scale (VAS) at t0 (baseline), t1 (30 days of treatment), t2 (60 days of treatments), t3 (90 days of treatments) 3. General oral health condition assessed using the Clinical Global Impression Scale for Severity of Illness (CGI-S) at t0 (baseline), t1 (30 days of treatment), t2 (60 days of treatments), t3 (90 days of treatments) 4. General condition of gingivitis assessed using the Clinical Global Impression Scale for Improvement (CGI-I) at t0 (baseline), t1 (30 days of treatment), t2 (60 days of treatments), t3 (90 days of treatments) | — |
Countries
Italy
Contacts
Public ContactAlessandra Baldi
Outcome results
None listed