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OpenTrials
Completed

NCT Number: NCT02490618

The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy

The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZLeuven

Leuven, 3000, Belgium

About this study

The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.

Recruitment: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial with within each patient a split mouth design. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients.

Selection of the 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 40 patients
  • ≥ 18 years of age
  • scaling and rootplaning received at least 3 months ago
  • Patients diagnosed with residual pockets (at least 2), with the definition of residual pockets:> 5mm or 5 and BOP+
  • Willing and able to give written informed consent

Exclusion criteria

  • patients with aggressive periodontitis
  • patients who smoke
  • pregnant or lactating woman
  • patients with poorly controlled diabetes
  • patients taking bisphosphonate mediation
  • patient who had taken systemic antibiotics 3 months prior to treatment

Treatment and study plan

Probiotic tablet- Biogaia

Other

Placebo tablet

Other

Primary outcomes

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

    Time frame: 3-6 months

  2. Recessions (REC) at teeth with residual pockets

    Time frame: 3-6 months

  3. Clinical Attachment Loss (CAL) at teeth with residual pockets

    Time frame: 3-6 months

Secondary outcomes

  1. Plaque at teeth with residual pockets

    Time frame: 3-6 months

  2. Bleeding on Probing (BoP) at teeth with residual pockets

    Time frame: 3-6 months

  3. Overall PPD, REC, CAL

    Time frame: 3-6 months

  4. Microbial samples: deepest pocket, saliva, tongue

    Time frame: 3-6 months

  5. Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)

    Time frame: 3-6 months

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • BioGaia AB

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2015
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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