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

Universitaire Ziekenhuizen KU Leuven

Status: Withdrawn

Conditions: Periodontitis

Treatments: Other: Prebiotic; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02520375

s58074

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 40 patients

• ≥ 36 years of age

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• 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

Trial design

0 participants in 2 patient groups, including a placebo group

Prebiotic

Experimental group

Description:

This group will be administered a prebiotic mouthrinse and toothpaste

Treatment:

Other: Prebiotic

Control

Placebo Comparator group

Description:

This group will be administered a control mouthrinse and toothpaste

Treatment:

Other: Control