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

Mouth Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913235
• Other study ID #: UCPH_OI_002
• Status: Completed
• Phase: N/A
• First received: September 20, 2016
• Last updated: February 2, 2017
• Start date: September 2016
• Est. completion date: January 2, 2017

Study information

• Verified date: February 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2, 2017
• Est. primary completion date: January 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Mouth Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Rigshospitalet, Denmark, The Forsyth Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of changes in a-diversity in saliva samples before and after discontinuation of regular oral care	Comparison of a-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	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	10 days of discontinuation of regular oral care and 14 days after resuming regular oral care