| Registry | NCT05548361 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 90 (Actual) |
| Sponsor | Cukurova University (Other); collaborators: BioGaia AB, Sunstar |
| Conditions | Periodontitis, Chlorhexidine, Probiotic |
| Interventions | active chlorhexidine and placebo probiotic, placebo chlorhexidine and active probiotic, active chlorhexidine and active probiotic (Combination product) |
| Dates | start 2022-04-01, primary completion 2024-12-01, completion 2024-12-01, first posted 2022-09-21, last updated 2025-06-15 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Periodontitis All trials for Chlorhexidine All trials of active chlorhexidine and placebo probiotic All trials of placebo chlorhexidine and active probiotic
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Active Chx | Experimental | Combination Product: active chlorhexidine and placebo probiotic | This group will receive active chlorhexidine and placebo probiotics |
| Active probiotics | Experimental | Combination Product: placebo chlorhexidine and active probiotic | This group will receive placeo chlorhexidine and active probiotics |
| Active Chx & probiotics | Experimental | Combination Product: active chlorhexidine and active probiotic | This group will receive active chlorhexidine and active probiotics |
Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Cukurova university Faculty of Dentistry | Adana | Turkey (Türkiye) |