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

Not Applicable

Withdrawn

• Conditions: Periodontitis
• Interventions: Other: Prebiotic; Other: Control

• Registration Number: NCT02520375
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-14
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prebiotic	Prebiotic	This group will be administered a prebiotic mouthrinse and toothpaste
Control	Control	This group will be administered a control mouthrinse and toothpaste

Primary Outcome Measures

Name	Time	Method
Pocket Probing Depth (PPD) at teeth with residual pockets	Baseline - 6 months	Pocket probing depth measured with Merrit B prob