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OpenTrials
Completed

NCT Number: NCT05548361

The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis

The aim of this study is determining the additional effect of a 2-week home usage of chlorhexidine in periodontitis patients undergoing scaling and root planing supplemented with a dual-strain probiotic lozenge.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova university Faculty of Dentistry

Adana, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosed with generalized (>30% of teeth affected) periodontitisstage III and IV periodontitis, grade B or C (C only with smoker modifier) = generalized chronic periodontitis including smokers
  • A minimum of three natural teeth in each quadrant, excluding third molars
  • Willing and able to give informed consent
  • Not more than 50% of the patients in each group will be smokers.
  • Smokers should smoke between 10 to 40 cigarettes a day

Exclusion criteria

  • Patients with localized periodontitis or periodontitis stage I or II or grade A or grade C or grade C with diabetes modifier
  • Patients with orthodontic appliances (removable or fixed)
  • Pregnant or lactating woman
  • Patients with a history of systemic diseases that may correlate with periodontal health, such as diabetesrheumatic fever, liver or kidney disease, and neurological deficiencies
  • Patients taking medication which may affect the periodontium (bisphosphonates, phenytoin, cyclosporin, nifidepine, chronic use of non-steroidal anti-inflammatory drugs)
  • Patient who had taken systemic antibiotics up to 3 months prior to treatment or medical conditions requiring prophylactic antibiotic coverage
  • Participation in any other clinical study
  • Tobacco chewing or sniffing

Treatment and study plan

active chlorhexidine and placebo probiotic

Combination Product

the randomized patients will be receive active chlorhexidine rinse and placebo probiotic

placebo chlorhexidine and active probiotic

Combination Product

the randomized patients will receive placebo chlorhexidine rinse and active probiotic

active chlorhexidine and active probiotic

Combination Product

the randomized patients will receive active chlorhexidine rinse and active probiotic

Primary outcomes

  1. probing pocket depth

    Time frame: 6 months

    the distance between gingival margin and pocket base in millimeters

Secondary outcomes

  1. percentage of patients in low risk for disease progression

    Time frame: 6 months

    having less than 5 sites with probing pocket depth of 5 mm or more at the end of the trial.

  2. gingival recession

    Time frame: 6 months

    the distance between cementoenamel junction and gingival margin in millimeters

  3. clinical attachment level

    Time frame: 6 months

    the distance between cementoenamel junction and pocket base in millimeters

  4. full mouth bleeding and plaque score

    Time frame: 6 months

    the scores of bleeding on probing (positive or negative)

  5. microbial outcomes

    Time frame: 6 months

    pcr analysis of plaque samples (mean log10 cfg/ml)

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Collaborators

  • BioGaia AB
  • Sunstar

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2022
Registry last updated
Jun 15, 2025

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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