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

NCT05548361 — Not applicable, Completed, 90 participants, Cukurova University

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RegistryNCT05548361
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment90 (Actual)
SponsorCukurova University (Other); collaborators: BioGaia AB, Sunstar
ConditionsPeriodontitis, Chlorhexidine, Probiotic
Interventionsactive chlorhexidine and placebo probiotic, placebo chlorhexidine and active probiotic, active chlorhexidine and active probiotic (Combination product)
Datesstart 2022-04-01, primary completion 2024-12-01, completion 2024-12-01, first posted 2022-09-21, last updated 2025-06-15
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Periodontitis All trials for Chlorhexidine All trials of active chlorhexidine and placebo probiotic All trials of placebo chlorhexidine and active probiotic

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Active ChxExperimentalCombination Product: active chlorhexidine and placebo probioticThis group will receive active chlorhexidine and placebo probiotics
Active probioticsExperimentalCombination Product: placebo chlorhexidine and active probioticThis group will receive placeo chlorhexidine and active probiotics
Active Chx & probioticsExperimentalCombination Product: active chlorhexidine and active probioticThis group will receive active chlorhexidine and active probiotics
  • 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

+Outcome measures

Primary outcomes

  • probing pocket depth [6 months]: the distance between gingival margin and pocket base in millimeters

Secondary outcomes

  • percentage of patients in low risk for disease progression [6 months]: having less than 5 sites with probing pocket depth of 5 mm or more at the end of the trial.
  • gingival recession [6 months]: the distance between cementoenamel junction and gingival margin in millimeters
  • clinical attachment level [6 months]: the distance between cementoenamel junction and pocket base in millimeters
  • full mouth bleeding and plaque score [6 months]: the scores of bleeding on probing (positive or negative)
  • microbial outcomes [6 months]: pcr analysis of plaque samples (mean log10 cfg/ml)

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Cukurova university Faculty of DentistryAdanaTurkey (Türkiye)