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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Chlorhexidine; Probiotic
• Intervention / Treatment: Combination product: active chlorhexidine and placebo probiotic; Combination product: placebo chlorhexidine and active probiotic; Combination product: active chlorhexidine and active probiotic

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey
    • Recruiting
    • Cukurova university Faculty of Dentistry
    • Contact: Cenk Haytac, Professor; Phone Number: +905324315743; Email: cenkhaytac@cu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Chx; This group will receive active chlorhexidine and placebo probiotics	Combination product: active chlorhexidine and placebo probiotic; the randomized patients will be receive active chlorhexidine rinse and placebo probiotic
Experimental: Active probiotics; This group will receive placeo chlorhexidine and active probiotics	Combination product: placebo chlorhexidine and active probiotic; the randomized patients will receive placebo chlorhexidine rinse and active probiotic
Experimental: Active Chx & probiotics; This group will receive active chlorhexidine and active probiotics	Combination product: active chlorhexidine and active probiotic; the randomized patients will receive active chlorhexidine rinse and active probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients in low risk for disease progression	having less than 5 sites with probing pocket depth of 5 mm or more at the end of the trial.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cukurova University
• Collaborators: BioGaia AB; Sunstar

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: CukurovaU-PerII

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No