Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment
1 other identifier
interventional
60
1 country
1
Brief Summary
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedNovember 2, 2022
November 1, 2022
10 months
August 22, 2022
November 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in microbial composition in dental plaque
Changes in alpha and beta diversity of microbial composition
Baseline vs. week 6 and week 12
Secondary Outcomes (5)
Changes in dental plaque
Baseline vs. week 6 and week 12
Changes in bleeding on probing
Baseline vs. week 6 and week 12
Changes in probing pocket depth
Baseline vs. week 6 and week 12
Changes in clinical attachment level
Baseline vs. week 6 and week 12
Changes in salivary levels of inflammatory cytokines
Baseline vs. week 6 and week 12
Study Arms (2)
Probiotic
EXPERIMENTALIn this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks
Placebo
PLACEBO COMPARATORIn this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Periodontitis stage 2-3, Grade B-C, generalized
You may not qualify if:
- Use of systemic antibiotics within the latest three months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Copenhagen, Department of Odontology
Copenhagen, 2200, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Computerized randomization only known to the principal investigator, who are not directly involved in data collection or data analysis
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor, dr. odont., PhD, DDS
Study Record Dates
First Submitted
August 22, 2022
First Posted
August 29, 2022
Study Start
September 1, 2022
Primary Completion
July 1, 2023
Study Completion
December 31, 2023
Last Updated
November 2, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share
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.