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WithdrawnNCT02520375Updated Mar 14, 2017

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

An interventional study of Prebiotic and Control in Periodontitis, sponsored by Universitaire Ziekenhuizen KU Leuven. Withdrawn. Per ClinicalTrials.gov, last updated 2017-03-14.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Periodontitis

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03

In context

Periodontitis

1,664 studies on the registry are indexed under Periodontitis; 328 are open to participants now.

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Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 958 studies on the registry; 263 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Allocation
Randomized
Masking
Double
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Prebiotic

    This group will be administered a prebiotic mouthrinse and toothpaste

    Other: Prebiotic

  • Placebo comparator
    Control

    This group will be administered a control mouthrinse and toothpaste

    Other: Control

Interventions

  • OtherPrebiotic
  • OtherControl
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What researchers measure

Primary outcomes

  1. Pocket Probing Depth (PPD) at teeth with residual pockets

    Pocket probing depth measured with Merrit B prob

    Time frame: Baseline - 6 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02520375
Responsible party
Sponsor
First posted
Aug 11, 2015
Primary completion
Dec 2017 (estimated)
Last update
Mar 14, 2017
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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