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

Not Applicable

Completed

• Conditions: Probiotic; Periodontitis; Chlorhexidine

• Registration Number: NCT05548361
• Lead Sponsor: Cukurova University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-21
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
probing pocket depth	6 months	the distance between gingival margin and pocket base in millimeters

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Cukurova university Faculty of Dentistry; 🇹🇷 Adana, Turkey