Chlorhexidine, Periodontitis, Probiotic
Conditions
Brief summary
The aim of this study is determining the additional effect of a 2-week home usage of chlorhexidine in periodontitis patients undergoing scaling and root planing supplemented with a dual-strain probiotic lozenge.
Interventions
COMBINATION_PRODUCTactive chlorhexidine and placebo probiotic
the randomized patients will be receive active chlorhexidine rinse and placebo probiotic
COMBINATION_PRODUCTplacebo chlorhexidine and active probiotic
the randomized patients will receive placebo chlorhexidine rinse and active probiotic
COMBINATION_PRODUCTactive chlorhexidine and active probiotic
the randomized patients will receive active chlorhexidine rinse and active probiotic
Sponsors
BioGaia AB
Sunstar
Cukurova University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosed with generalized (\>30% of teeth affected) periodontitisstage III and IV periodontitis, grade B or C (C only with smoker modifier) = generalized chronic periodontitis including smokers * A minimum of three natural teeth in each quadrant, excluding third molars * Willing and able to give informed consent * Not more than 50% of the patients in each group will be smokers. * Smokers should smoke between 10 to 40 cigarettes a day
Exclusion criteria
* Patients with localized periodontitis or periodontitis stage I or II or grade A or grade C or grade C with diabetes modifier * Patients with orthodontic appliances (removable or fixed) * Pregnant or lactating woman * Patients with a history of systemic diseases that may correlate with periodontal health, such as diabetesrheumatic fever, liver or kidney disease, and neurological deficiencies * Patients taking medication which may affect the periodontium (bisphosphonates, phenytoin, cyclosporin, nifidepine, chronic use of non-steroidal anti-inflammatory drugs) * Patient who had taken systemic antibiotics up to 3 months prior to treatment or medical conditions requiring prophylactic antibiotic coverage * Participation in any other clinical study * Tobacco chewing or sniffing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| probing pocket depth | 6 months | the distance between gingival margin and pocket base in millimeters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients in low risk for disease progression | 6 months | having less than 5 sites with probing pocket depth of 5 mm or more at the end of the trial. |
| gingival recession | 6 months | the distance between cementoenamel junction and gingival margin in millimeters |
| clinical attachment level | 6 months | the distance between cementoenamel junction and pocket base in millimeters |
| full mouth bleeding and plaque score | 6 months | the scores of bleeding on probing (positive or negative) |
| microbial outcomes | 6 months | pcr analysis of plaque samples (mean log10 cfg/ml) |
Countries
Turkey (Türkiye)
Outcome results
None listed