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

Not Applicable

Completed

• Conditions: Mouth Diseases
• Interventions: Procedure: Oral hygiene discontinuation group

• Registration Number: NCT02913235
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Primary Completion: 2017-01-02
• Study Completion: 2017-01-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral hygiene discontinuation group	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.

Primary Outcome Measures

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

Name	Time	Method
Comparison of species specific changes in saliva samples before and after discontinuation of regular oral care	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