The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis

Study Overview
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Brief Summary
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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.

Official Title
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The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis

Conditions
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Periodontitis, Chlorhexidine, Probiotic

Intervention / Treatment
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* Combination Product: active chlorhexidine and placebo probiotic
* Combination Product: placebo chlorhexidine and active probiotic
* Combination Product: active chlorhexidine and active probiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Chx<br>This group will receive active chlorhexidine and placebo probiotics | Combination Product: active chlorhexidine and placebo probiotic<br>* the randomized patients will be receive active chlorhexidine rinse and placebo probiotic<br>|
| Experimental: Active probiotics<br>This group will receive placeo chlorhexidine and active probiotics | Combination Product: placebo chlorhexidine and active probiotic<br>* the randomized patients will receive placebo chlorhexidine rinse and active probiotic<br>|
| Experimental: Active Chx & probiotics<br>This group will receive active chlorhexidine and active probiotics | Combination Product: active chlorhexidine and active probiotic<br>* the randomized patients will receive active chlorhexidine rinse and active probiotic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients in low risk for disease progression | having less than 5 sites with probing pocket depth of 5 mm or more at the end of the trial. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing pocket depth | the distance between gingival margin and pocket base in millimeters | 6 months | 
| gingival recession | the distance between cementoenamel junction and gingival margin in millimeters | 6 months | 
| clinical attachment level | the distance between cementoenamel junction and pocket base in millimeters | 6 months | 
| full mouth bleeding and plaque score | the scores of bleeding on probing (positive or negative) | 6 months | 
| microbial outcomes | pcr analysis of plaque samples (mean log10 cfg/ml) | 6 months |