The Oral Microbiota as Reservoir for Systemic Opportunistic Pathogens

NCT02619903 | Completed DMC

• 1 other identifier: 2015-279
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

Brief Summary

Small pilot studies with approximately 20 people per group support that eradication of the oral flora causes fewer exacerbations in chronic obstructive pulmonary disease (COPD) patients. The biological underpinning put forward is that eradicating the oral microbiome will eliminate a source of re-infection as the concentration of antibiotics prescribed to treat COPD exacerbations are not able to inhibit the bacteria in the oral biofilms that require 250 times higher concentration. The specific aim is to investigate if adding advanced dental cleaning to COPD treatment can (i) lower the number of exacerbations and (ii) improve the COPD symptoms the coming 12 months. In an effort to explain the underpinning mechanism we will collect oral dental biofilm samples at baseline and follow up in the treatment and control group to investigate changes in the composition of the biofilm. The subjects are selected by experienced COPD nurses. Exclusion criteria are having metastatic cancer or dementia. The COPD clinic informs the dental personal about COPD parameters, including spirometry data. At the dental clinic the patient answers a questionnaire, including a COPD assessment test (CAT) which has been validated extensively. The patients undergo a dental examination and are then randomized to test or control group. The test group go through supra- and subgingival scaling and scraping of the tongue as well as chlorhexidine rinse. The control group attends all visits. All subjects go through the intervention after 6 months and are followed up after 12 and 24 months using questionnaire, dental plaque sampling and spirometry. The COPD nurses reviewing their medical records assess number of exacerbations. A confirmation of the study hypothesis will be important in lowering the number of exacerbations in COPD patients, causing less suffering, less costs and less usage of antibiotics. If dental treatment is beneficial for exacerbation frequency it could be argued that dental treatment should be subsidized in this patient category.

Conditions

COPD Exacerbation; Pulmonary Disease, Chronic Obstructive; Dental Plaque

Outcome Measures

Primary Outcomes (1)

• COPD exacerbations in 12 months

  We will ask the patients how many exacerbations they had and go through medical records.

  12 months

Secondary Outcomes (1)

• COPD symptoms

  12 months

Other Outcomes (1)

• Changes in oral microbiome

  12 months

Study Arms (2)

COPD Control

NO INTERVENTION

Subjects with COPD recieve no treatment. When exiting the trial after 12 months, they do however receive the intervention.

COPD Test

ACTIVE COMPARATOR

Subjects with COPD that do get the additional dental cleaning, as well as dental examination.

Procedure: Dental cleaning

Interventions

Dental cleaning PROCEDURE

Dental scaling and cleaning to remove dental plaque as well as removing the tongue biofilm.

COPD Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD arm - COPD Gold standard 1-4.

You may not qualify if:

• Physically unable to make it to the dental clinic.

Sponsors & Collaborators

• Malmö University: lead
• Lund University: collaborator

Study Sites (2)

Folktandvarden Skane

Malmo, Sweden

Location

Orebro Specialisttandvard

Örebro, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dental Plaque

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Daniel Jönsson, DDS, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Test versus control for dental treatment in attenuating exacerbations in COPD.

Study Record Dates

• First Submitted: November 29, 2015
• First Posted: December 2, 2015
• Study Start: February 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)