The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis
Primary Purpose
Periodontitis, Chlorhexidine, Probiotic
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
active chlorhexidine and placebo probiotic
placebo chlorhexidine and active probiotic
active chlorhexidine and active probiotic
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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
Sites / Locations
- Cukurova university Faculty of DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Active Chx
Active probiotics
Active Chx & probiotics
Arm Description
This group will receive active chlorhexidine and placebo probiotics
This group will receive placeo chlorhexidine and active probiotics
This group will receive active chlorhexidine and active probiotics
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
probing pocket depth
the distance between gingival margin and pocket base in millimeters
gingival recession
the distance between cementoenamel junction and gingival margin in millimeters
clinical attachment level
the distance between cementoenamel junction and pocket base in millimeters
full mouth bleeding and plaque score
the scores of bleeding on probing (positive or negative)
microbial outcomes
pcr analysis of plaque samples (mean log10 cfg/ml)
Full Information
NCT ID
NCT05548361
First Posted
September 12, 2022
Last Updated
August 31, 2023
Sponsor
Cukurova University
Collaborators
BioGaia AB, Sunstar
1. Study Identification
Unique Protocol Identification Number
NCT05548361
Brief Title
The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis
Official Title
The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
Collaborators
BioGaia AB, Sunstar
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Chlorhexidine, Probiotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Chx
Arm Type
Experimental
Arm Description
This group will receive active chlorhexidine and placebo probiotics
Arm Title
Active probiotics
Arm Type
Experimental
Arm Description
This group will receive placeo chlorhexidine and active probiotics
Arm Title
Active Chx & probiotics
Arm Type
Experimental
Arm Description
This group will receive active chlorhexidine and active probiotics
Intervention Type
Combination Product
Intervention Name(s)
active chlorhexidine and placebo probiotic
Intervention Description
the randomized patients will be receive active chlorhexidine rinse and placebo probiotic
Intervention Type
Combination Product
Intervention Name(s)
placebo chlorhexidine and active probiotic
Intervention Description
the randomized patients will receive placebo chlorhexidine rinse and active probiotic
Intervention Type
Combination Product
Intervention Name(s)
active chlorhexidine and active probiotic
Intervention Description
the randomized patients will receive active chlorhexidine rinse and active probiotic
Primary Outcome Measure Information:
Title
percentage of patients in low risk for disease progression
Description
having less than 5 sites with probing pocket depth of 5 mm or more at the end of the trial.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
probing pocket depth
Description
the distance between gingival margin and pocket base in millimeters
Time Frame
6 months
Title
gingival recession
Description
the distance between cementoenamel junction and gingival margin in millimeters
Time Frame
6 months
Title
clinical attachment level
Description
the distance between cementoenamel junction and pocket base in millimeters
Time Frame
6 months
Title
full mouth bleeding and plaque score
Description
the scores of bleeding on probing (positive or negative)
Time Frame
6 months
Title
microbial outcomes
Description
pcr analysis of plaque samples (mean log10 cfg/ml)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cukurova university Faculty of Dentistry
City
Adana
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cenk Haytac, Professor
Phone
+905324315743
Email
cenkhaytac@cu.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis
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