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Completed

NCT Number: NCT02913235

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

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.

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Key information

Conditions

Mouth Diseases Stomatognathic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral hygiene discontinuation group

Procedure

Discontinuation of regular oral hygiene for 10 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Rigshospitalet, Denmark
  • The Forsyth Institute

Registry information

Official study title

Does Short Term Discontinuation of Self-performed Oral Hygiene Procedures Influence the Composition of the Salivary Microbiota?

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 23, 2016
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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