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OpenTrials
Completed

NCT Number: NCT04137419

Probiotics as Adjunct to Nonsurgical Periodontal Treatment

ProlacSan probiotic lozenges and gels contain L. plantarum and L. brevis strains with proven in vitro antimicrobial activity against P. gingivalis. In our study we aim to investigate proposed benefit of ProlacSan as adjunct to conventional initial periodontal treatment in a group (n = 40) of Grade III and IV periodontitis patients. Patients will be randomized in two groups receiving either probiotic (n = 20) or placebo (n = 20) after completion of nonsurgical treatment within 7 days. Before treatment and after three months, standard periodontal parameters will be measured by masked examiner and plaque samples harvested for cultivation of 9 most relevant periodontal pathogens. One lozenge per day of probiotic/placebo will be used during 3 months healing period. Primary outcome measures will be the number of persisting sites per patient that need additional surgical treatment defined as sites with probing depth > 4 mm and bleeding on probing.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Dental Clinic

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • periodontitis stage III or IV
  • at least 20 teeth for evaluation
  • besides solitary crowns, no other prosthodontic tooth replacements
  • good systemic health
  • smoking less than 10 cig/day

Exclusion criteria

  • periodontal treatment lass than 1 year before inclusion
  • antibiotic therapy in the last 6 months
  • chronic systemic diseases with the impact on periodontium or healing process
  • medication with the impact on periodontium or healing process

Treatment and study plan

Probiotic lozenges

Dietary Supplement

Probiotic strains

Other names: ProlacSan

Placebo

Other

Similar to ProlacSan lozenges in taste in colour

Primary outcomes

  1. Residual diseased site number

    Time frame: 3 months

    No of sites with probing pocket depth (PPD) > 4 mm and bleeding on probing after treatment

  2. Gingival bleeding index

    Time frame: 3 months

    Percentage od bleeding sites after gentle probing of gingival sulcus

Secondary outcomes

  1. Probing pocket depth reduction

    Time frame: 3 months

    Change in probing pocket depth

  2. Recession

    Time frame: 3 months

    Change of the position of the gingival margin

  3. Bleeding on probing

    Time frame: 3 months

    Bleeding after measurement of pocket depth

Sponsors and collaborators

Lead sponsor

University of Ljubljana

Other

Registry information

Official study title

Probiotics as Adjunct to Nonsurgical Periodontal Treatment, Double Blinded Randomized Controled Clinical Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 24, 2019
Registry last updated
May 1, 2020

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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