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

Not Applicable

Recruiting

• Conditions: Probiotic; Periodontitis; Chlorhexidine
• Interventions: Combination Product: active chlorhexidine and placebo probiotic; Combination Product: placebo chlorhexidine and active probiotic; Combination Product: active chlorhexidine and active probiotic

• 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
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• 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

Arm && Interventions

Group	Intervention	Description
Active Chx	active chlorhexidine and placebo probiotic	This group will receive active chlorhexidine and placebo probiotics
Active probiotics	placebo chlorhexidine and active probiotic	This group will receive placeo chlorhexidine and active probiotics
Active Chx & probiotics	active chlorhexidine and active probiotic	This group will receive active chlorhexidine and active probiotics

Primary 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.

Secondary Outcome Measures

Name	Time	Method
microbial outcomes	6 months	pcr analysis of plaque samples (mean log10 cfg/ml)
gingival recession	6 months	the distance between cementoenamel junction and gingival margin in millimeters
full mouth bleeding and plaque score	6 months	the scores of bleeding on probing (positive or negative)
probing pocket depth	6 months	the distance between gingival margin and pocket base in millimeters
clinical attachment level	6 months	the distance between cementoenamel junction and pocket base in millimeters

Trial Locations

Locations (1)

Cukurova university Faculty of Dentistry; 🇹🇷 Adana, Turkey