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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02520375
• Other study ID #: s58074
• Status: Withdrawn
• Phase: N/A
• First received: July 1, 2015
• Last updated: March 10, 2017

Study information

• Verified date: March 2017
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Other:
• Prebiotic

• Control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

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