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

Sponsor

Cukurova University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05548361

Collaborator

BioGaia AB (Industry), Sunstar (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis Chlorhexidine Probiotic	Combination Product: active chlorhexidine and placebo probiotic Combination Product: placebo chlorhexidine and active probiotic Combination Product: active chlorhexidine and active probiotic	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cukurova university Faculty of Dentistry	Adana		Turkey

Sponsors and Collaborators

Cukurova University
BioGaia AB
Sunstar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mustafa Ozcan, Associate professor, Cukurova University

ClinicalTrials.gov Identifier:

NCT05548361

Other Study ID Numbers:

CukurovaU-PerII

First Posted:

Sep 21, 2022

Last Update Posted:

Sep 21, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Periodontitis

Chlorhexidine

Chlorhexidine gluconate

Study Results

No Results Posted as of Sep 21, 2022