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Salivary Bacterial Associations to Short Term Discontinuation of Self-performed Oral Hygiene

Primary Purpose

Mouth Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral hygiene discontinuation group
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mouth Diseases focused on measuring biofilm, saliva, bacteria, oral hygiene

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Oral hygiene discontinuation group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Comparison of changes in α-diversity in saliva samples before and after discontinuation of regular oral care
    Comparison of α-diversity in saliva samples before and after discontinuation of regular oral hygiene

    Secondary Outcome Measures

    Comparison of species specific changes in saliva samples before and after discontinuation of 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

    Full Information

    First Posted
    September 20, 2016
    Last Updated
    February 2, 2017
    Sponsor
    University of Copenhagen
    Collaborators
    The Forsyth Institute, Rigshospitalet, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02913235
    Brief Title
    Salivary Bacterial Associations to Short Term Discontinuation of Self-performed Oral Hygiene
    Official Title
    Does Short Term Discontinuation of Self-performed Oral Hygiene Procedures Influence the Composition of the Salivary Microbiota?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    January 2, 2017 (Actual)
    Study Completion Date
    January 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Copenhagen
    Collaborators
    The Forsyth Institute, Rigshospitalet, Denmark

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mouth Diseases
    Keywords
    biofilm, saliva, bacteria, oral hygiene

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral hygiene discontinuation group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Oral hygiene discontinuation group
    Intervention Description
    Discontinuation of regular oral hygiene for 10 days
    Primary Outcome Measure Information:
    Title
    Comparison of changes in α-diversity in saliva samples before and after discontinuation of regular oral care
    Description
    Comparison of α-diversity in saliva samples before and after discontinuation of regular oral hygiene
    Time Frame
    10 days of discontinuation of regular oral care and 14 days after resuming regular oral care
    Secondary Outcome Measure Information:
    Title
    Comparison of species specific changes in saliva samples before and after discontinuation of regular oral care
    Description
    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
    Time Frame
    10 days of discontinuation of regular oral care and 14 days after resuming regular oral care

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Belstrøm, DDS, PhD
    Organizational Affiliation
    University of Copenhagen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    29662960
    Citation
    Belstrom D, Sembler-Moller ML, Grande MA, Kirkby N, Cotton SL, Paster BJ, Twetman S, Holmstrup P. Impact of Oral Hygiene Discontinuation on Supragingival and Salivary Microbiomes. JDR Clin Trans Res. 2018 Jan;3(1):57-64. doi: 10.1177/2380084417723625. Epub 2017 Jul 31.
    Results Reference
    derived

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    Salivary Bacterial Associations to Short Term Discontinuation of Self-performed Oral Hygiene

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