Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment
Primary Purpose
Periodontitis
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Periodontitis stage 2-3, Grade B-C, generalized
Exclusion Criteria:
- • Use of systemic antibiotics within the latest three months.
Sites / Locations
- University of Copenhagen, Department of OdontologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks
In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks
Outcomes
Primary Outcome Measures
Changes in microbial composition in dental plaque
Changes in alpha and beta diversity of microbial composition
Secondary Outcome Measures
Changes in dental plaque
Changes in mean level of dental plaque
Changes in bleeding on probing
Changes in mean level of bleeding on probing
Changes in probing pocket depth
Changes in mean level of probing pocket depth
Changes in clinical attachment level
Changes in mean level of clinical attachment level
Changes in salivary levels of inflammatory cytokines
Changes in mean salivary levels of selected inflammatory cytokines
Full Information
NCT ID
NCT05518747
First Posted
August 22, 2022
Last Updated
November 1, 2022
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT05518747
Brief Title
Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment
Official Title
Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.
Detailed Description
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks
. 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks.
Clinical measurements and sampling will be performed at baseline, week 6 and week 12.
Primary endpoint: Changes in microbial composition.
Secondary endpoints: Changes in clinical and immunological parameters
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded randomized clinical trial with a test and placebo group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Computerized randomization only known to the principal investigator, who are not directly involved in data collection or data analysis
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
In this group participants will receive probiotic supplements twice a day (morning and evening) for a period of 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
In this group participants will receive placebo twice a day (morning and evening) for at period of 12 weeks.
Primary Outcome Measure Information:
Title
Changes in microbial composition in dental plaque
Description
Changes in alpha and beta diversity of microbial composition
Time Frame
Baseline vs. week 6 and week 12
Secondary Outcome Measure Information:
Title
Changes in dental plaque
Description
Changes in mean level of dental plaque
Time Frame
Baseline vs. week 6 and week 12
Title
Changes in bleeding on probing
Description
Changes in mean level of bleeding on probing
Time Frame
Baseline vs. week 6 and week 12
Title
Changes in probing pocket depth
Description
Changes in mean level of probing pocket depth
Time Frame
Baseline vs. week 6 and week 12
Title
Changes in clinical attachment level
Description
Changes in mean level of clinical attachment level
Time Frame
Baseline vs. week 6 and week 12
Title
Changes in salivary levels of inflammatory cytokines
Description
Changes in mean salivary levels of selected inflammatory cytokines
Time Frame
Baseline vs. week 6 and week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Periodontitis stage 2-3, Grade B-C, generalized
Exclusion Criteria:
• Use of systemic antibiotics within the latest three months.
Facility Information:
Facility Name
University of Copenhagen, Department of Odontology
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Belstrøm, DDS, PhD
Phone
+45 21300580
Email
dbel@sund.ku.dk
First Name & Middle Initial & Last Name & Degree
Merete Markvart, DDS, PhD
Phone
+45 35 33 77 65
Email
mema@sund.ku.dk
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All microbial data will be shared, as these will be uploaded to a publically accessible database.
In accordance with GDPR, immunological and clinical data will only be shared as mean (range) values.
Learn more about this trial
Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment
We'll reach out to this number within 24 hrs