Effects of Prebiotic Oral Healthcare Products as an Adjunct to Non-surgical Periodontal Therapy

Study Overview
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Brief Summary
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The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning.

Detailed Description
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The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning. Study design: this study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients. Study population: adults, who consult at the department of Periodontology at the University Hospital Leuven and who fit the inclusion criteria will be asked to participate in this study.

Official Title
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Effects of Prebiotic Oral Healthcare Products as an Adjunct to Non-surgical Periodontal Therapy

Conditions
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Periodontitis

Intervention / Treatment
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* Other: Prebiotic
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 patients ≥ 36 years of age - Page 4 of 4 [DRAFT] - No previous scaling and rootplaning Clinical diagnosis: severe generalized periodontitis characterized by the presence of > 14 affected teeth when > 14 teeth are present (if number of teeth present is < 14, 8-14 teeth need to be affected) with an attachment loss of > 6mm prior to initial non-surgical periodontal therapy. A minimum of 3 natural teeth in every quadrant Willing and able to give written informed consent Exclusion Criteria: Patients with aggressive periodontitis or necrotizing periodontitis Patients who smoke Pregnant or lactating woman A history of diabetes, rheumatic fever, liver or kidney disease, neurological deficiencies, or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, nifedipine, chronic use of non-steroidal antiinflammatory drugs) Patients with poorly controlled diabetes Patients taking bisphosphonate mediation Patient who have taken systemic antibiotics 3 months prior to treatment
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

Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prebiotic<br>This group will be administered a prebiotic mouthrinse and toothpaste | Other: Prebiotic<br> <br> |
| Placebo Comparator: Control<br>This group will be administered a control mouthrinse and toothpaste | Other: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket Probing Depth (PPD) at teeth with residual pockets | Pocket probing depth measured with Merrit B prob | Baseline - 6 months |