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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02520375

Enrollment

Registered

2015-08-11

Start date

Unknown

Completion date

Unknown

Last updated

2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

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.

Interventions

OTHERPrebiotic

OTHERControl

Study design

Allocation

RANDOMIZED

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026