Salivary Bacterial Associations to Short Term Discontinuation of Self-performed Oral Hygiene
February 2, 2017 updated by: Daniel Belstrøm, DDS, PhD, University of Copenhagen
Does Short Term Discontinuation of Self-performed Oral Hygiene Procedures Influence the Composition of the Salivary Microbiota?
The purpose of the present investigation is to record and compare bacterial compositions in supragingival plaque samples and saliva samples in subjects discontinuing regular oral hygiene for 10 days.
The hypothesis is that the composition of the salivary microbiota might reflect local bacterial alterations in relation to discontinuation of oral hygiene.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
35 orally healthy individuals will be enrolled in this study, in which they will discontinue regular oral hygiene procedures for a period of 10 days.
Clinical registrations and collection of microbiological samples (supragingival and saliva) will be performed at baseline and 4, 7 and 10 days after discontinuation of regular oral hygiene, and will be repeated 14 days after regular oral hygiene has been resumed.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Oral and systemically healthy individuals
Exclusion Criteria:
- Periodontitis
- Dental caries
- Systemic diseases or medications with known associations to oral health
- Antibiotics within the latest 6 month
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Oral hygiene discontinuation group
The intervention of the present study is discontinuation of regular oral hygiene procedures for a period of 10 days.
Discontinuation of oral hygiene will allow undisturbed biofilm formation (supragingival dental plaque) along the gingival margin of the teeth.
After 10 days all individuals will resume regular oral hygiene.
Clinical registrations and collection of microbiological samples (supragingival and saliva) will be performed at baseline and 4, 7 and 10 days after discontinuation of regular oral hygiene, and will be repeated 14 days after regular oral hygiene has been resumed.
|
Discontinuation of regular oral hygiene for 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of changes in α-diversity in saliva samples before and after discontinuation of regular oral care
Time Frame: 10 days of discontinuation of regular oral care and 14 days after resuming regular oral care
|
Comparison of α-diversity in saliva samples before and after discontinuation of regular oral hygiene
|
10 days of discontinuation of regular oral care and 14 days after resuming regular oral care
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of species specific changes in saliva samples before and after discontinuation of regular oral care
Time Frame: 10 days of discontinuation of regular oral care and 14 days after resuming regular oral care
|
Comparison of relative abundance of bacterial species in saliva samples at baseline to samples collected 10 days after discontinuation of regular oral hygiene and to samples collected 14 days after oral hygiene procedures has been resumed
|
10 days of discontinuation of regular oral care and 14 days after resuming regular oral care
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Belstrøm, DDS, PhD, University of Copenhagen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
January 2, 2017
Study Completion (Actual)
January 2, 2017
Study Registration Dates
First Submitted
September 20, 2016
First Submitted That Met QC Criteria
September 21, 2016
First Posted (Estimate)
September 23, 2016
Study Record Updates
Last Update Posted (Estimate)
February 3, 2017
Last Update Submitted That Met QC Criteria
February 2, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCPH_OI_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.