Periodontitis Oral Health
Conditions
Interventions
The study is randomized into four groups, using the IBM SPSS Statistics 21.0 software or equivalent program (eg https://www.random.org/lists/), including probiotics/placebo groups in patients with per
Sponsors
Instituto Superior de Ciências da Saúde Egas Moniz
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-65 years old diagnosed with untreated periodontitis 2. Adults aged 18-65 years old without periodontitis (health periodontal)
Exclusion criteria
Exclusion criteria: 1. Unsigned informed consent 2. Pregnant and lactating women 3. Systemic diseases (eg inflammatory bowel diseases, diabetes, infectious diseases, transplant recipients, etc.) 4. Use of certain medications (eg corticoids, cyclosporine, xerostomy medications, NSAIDs, etc.) 5. Taking antibiotics and/or probiotics in the last 3 months 6. Use of antiseptics 7. Drug and/or alcohol abuse, smoking 8. Chemotherapy, radiotherapy for less than 1 year 9. Periodontal treatment for less than 6 months 10. Mental illness 11. Intolerance to lactose, gluten or tablet component 12. Participants with incomplete data or not using ¼ of the pills
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following outcomes will be measured at baseline, 3 and 6 months: 1. Clinical outcomes: IP, IG, PPD, BoP/suppuration (%); PPD, REC, CAL (mm) measured using a CP12 Hu-Friedy periodontal probe (0.06 mm diameter - 0.25N force) and a periodontal chart 2. Microbiological outcomes: subgingival microbiome, samples of subgingival plaque will be collected with Gracey curettes at an affected site (with PPD=/>6mm with or without BoP), placed in tubes containing DNA/RNA stabilizers and stored at -80ºC until shipment to a Canadian company Microbiome Insight. Microbiome Insight will perform DNA extraction and sequencing of the V4 region of the 16S rRNA coding gene to identify and quantify the microbial communities present in the samples and to compare the microbial profile changes between the study groups before and after the probiotic/placebo implementation 3. Immunological outcomes: cytokines (IL1-ß, IL-6 and TNF-a [pg/ml]) and other markers (MMP-8 and PGE2 [pg/ml]) in gingival crevicular fluid. Samples of gingival crevicular fluid will be collected with sterile absorbent paper strips, and placed for 30 sec in contact with an affected site (bag with PPD=/>6mm with or without BoP). Then, they will be inserted into the Periotron 8000 (Periotron Ide-interstate, NY, USA) to quantify the volume collected. Afterwards, they will be placed in an Eppendorf tube with a filter and stored at -80ºC until they are sent to the Complutense University of Madrid, Spain, which will analyze the concentration of mediators by enzyme immunoassay ELISA | — |
Secondary
| Measure | Time frame |
|---|---|
| The following outcomes will be measured at baseline, 3 and 6 months: 1. Adverse effects measured using a questionnaire (nature/severity/duration) 2. Adherence rate measured using a questionnaire and by calculating the remaining tablet numbers | — |
Countries
Portugal
Outcome results
None listed