Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation
NCT ID: NCT05268757
Last Updated: 2022-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
80 participants
INTERVENTIONAL
2022-01-05
2022-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Oral Probiotics on Oral Homeostasis
NCT04071210
Effects on Tablets Containing Probiotic Candidate Strains
NCT02633345
Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment
NCT05518747
Salivary Bacterial Associations to Short Term Discontinuation of Self-performed Oral Hygiene
NCT02913235
The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
NCT05330793
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care.
Clinical measurements and sampling will be performed at baseline, day 14 and day 28
Primary endpoint: Changes in microbial composition.
Secondary endpoints: Changes in clinical and immunological parameters
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Probiotic
In this group participants will receive probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).
Oral hygiene discontinuation
Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care
Placebo
In this group participants will receiveplacebo twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care).
Oral hygiene discontinuation
Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oral hygiene discontinuation
Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Current smokers
* Any systemic diseases and current use of any medication with known effect on oral health
* Use of systemic antibiotics within the latest three months
* Age \< 18 yrs., and age \> 30 yrs.
18 Years
30 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Deerland Probiotics and Enzymes
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Daniel Belstrøm, DDS, PhD
DDS, PhD, Dr. odont
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Copenhagen, Department of Odontology
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UCPH_01_006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.