The beneficial effect on gingivitis of a food supplement based on botanical extracts

Not Applicable

Completed

• Conditions: Preventing periodontitis in individuals with symptomatic gingivitis; Oral Health

• Registration Number: ISRCTN16727861
• Lead Sponsor: Epo S.r.l.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-09
• Study Completion: 2023-10-11
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>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)<br>

Secondary Outcome Measures

Name	Time	Method
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.<br>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)<br>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)<br>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)