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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548361
• Other study ID #: CukurovaU-PerII
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2023
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chlorhexidine
• Periodontitis
• Probiotic

Intervention

Combination Product:
• active chlorhexidine and placebo probiotic
the randomized patients will be receive active chlorhexidine rinse and placebo probiotic
• placebo chlorhexidine and active probiotic
the randomized patients will receive placebo chlorhexidine rinse and active probiotic
• active chlorhexidine and active probiotic
the randomized patients will receive active chlorhexidine rinse and active probiotic

Locations

Country	Name	City	State
Turkey	Cukurova university Faculty of Dentistry	Adana

Sponsors (3)

Lead Sponsor	Collaborator
Cukurova University	BioGaia AB, Sunstar

Country where clinical trial is conducted

Turkey, 

Outcome

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