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

NCT02913235 | Completed DMC

• 1 other identifier: UCPH_OI_002
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mouth Diseases

Keywords

biofilm; saliva; bacteria; oral hygiene

Outcome Measures

Primary Outcomes (1)

• 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

  10 days of discontinuation of regular oral care and 14 days after resuming regular oral care

Secondary Outcomes (1)

• 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

Study Arms (1)

Oral hygiene discontinuation group

EXPERIMENTAL

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

Interventions

Oral hygiene discontinuation group PROCEDURE

Discontinuation of regular oral hygiene for 10 days

Oral hygiene discontinuation group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Oral and systemically healthy individuals

You may not qualify if:

• Periodontitis
• Dental caries
• Systemic diseases or medications with known associations to oral health
• Antibiotics within the latest 6 month

Sponsors & Collaborators

• University of Copenhagen: lead
• The Forsyth Institute: collaborator
• Rigshospitalet, Denmark: collaborator

Related Publications (1)

• 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.

  PMID: 29662960 DERIVED

MeSH Terms

Conditions

Mouth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

• Daniel Belstrøm, DDS, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2016
• Primary Completion: January 2, 2017
• Study Completion: January 2, 2017
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share