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

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ClinicalTrials.gov Identifier: NCT02913235
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : February 3, 2017
Sponsor:
Collaborators:
The Forsyth Institute
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Daniel Belstrøm, DDS, PhD, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Mouth Diseases Procedure: Oral hygiene discontinuation group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Does Short Term Discontinuation of Self-performed Oral Hygiene Procedures Influence the Composition of the Salivary Microbiota?
Study Start Date : September 2016
Actual Primary Completion Date : January 2, 2017
Actual Study Completion Date : January 2, 2017

Resource links provided by the National Library of Medicine


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.
Procedure: Oral hygiene discontinuation group
Discontinuation of regular oral hygiene for 10 days




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913235


Sponsors and Collaborators
University of Copenhagen
The Forsyth Institute
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Daniel Belstrøm, DDS, PhD University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Belstrøm, DDS, PhD, Assistant professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02913235     History of Changes
Other Study ID Numbers: UCPH_OI_002
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Daniel Belstrøm, DDS, PhD, University of Copenhagen:
biofilm
saliva
bacteria
oral hygiene

Additional relevant MeSH terms:
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Mouth Diseases
Stomatognathic Diseases