Evidence map›Paper›PMID 36823669›Full record

Trial reportTrials2023

The impact of gingivitis reduction on lung function: a randomized trial under intensified oral hygiene.

Jan Kühnisch, Tianyu Zhao, Randi J Bertelsen, Rudolf A Jörres, Dennis Nowak, Joachim Heinrich

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact, top 98% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 0 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Jan KühnischDepartment of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians University Munich, Germany, Munich, Germany. jkuehn@dent.med.uni-muenchen.de.ORCID http://orcid.org/0000-0003-4063-2291
Tianyu ZhaoInstitute and Clinic for Occupational, Social and Environmental Medicine, University Hospital, Ludwig-Maximilians University Munich, Germany, Munich, Germany.
Randi J BertelsenDepartment of Clinical Science, University of Bergen, Bergen, Norway.
Rudolf A JörresInstitute and Clinic for Occupational, Social and Environmental Medicine, University Hospital, Ludwig-Maximilians University Munich, Germany, Munich, Germany.
Dennis NowakInstitute and Clinic for Occupational, Social and Environmental Medicine, University Hospital, Ludwig-Maximilians University Munich, Germany, Munich, Germany.
Joachim HeinrichInstitute and Clinic for Occupational, Social and Environmental Medicine, University Hospital, Ludwig-Maximilians University Munich, Germany, Munich, Germany.
Ludwig-Maximilians-Universität München · DEUniversity of Bergen · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeriodontal disease and lung function impairment were found to be associated with low-grade systemic or local inflammation, and it might be that gingival/periodontal inflammation triggers lung function due to systemic inflammation or the transfer of oral bacteria or its components to the lung. A recent observational study in non-smoking subjects showed that lung volumes and flow rates were significantly reduced by 71-185 ml for severe gingivitis regardless of the adjustment for potential confounders. The result did not show any confounding by smoking, and the association between gingivitis and lower lung function was not modified by systemic inflammation. The designed interventional trial primarily aims to test the hypothesis that gingivitis reduction by optimized daily oral hygiene, professional tooth cleaning and antibacterial chlorhexidine (CHX)-containing mouth rinse improves lung function in terms of forced vital capacity (FVC) by at least 2%. The secondary objective will test the hypothesis that gingivitis reduction improves forced expiratory volume in 1 s (FEV1) and forced expiratory flow at 25-75% of the pulmonary volume (FEF25-75) by at least 2%. Furthermore, the influence of the oral microbiome will be taken into account.

methodsThe study has to include 120 non-smoking subjects aged between 18 and 30 years with biofilm-induced gingivitis. The chosen "waiting control group design" will compare the immediate intervention group with the delayed intervention group, which serves as a control group. Dental and gingival status, lung function and oral microbiome will be recorded. The intensified preventive intervention-professional tooth cleaning, one-stage full-mouth disinfection with CHX and safeguarding an optimal daily oral hygiene by each subject-cannot be blinded, but the outcome measurement in terms of lung function tests is blind. DISCUSSION: This proposed multidisciplinary study has several strengths. Only one previous intervention study with patients with severe periodontitis (mostly smokers) has been performed. It is novel to include non-smoking subjects with mild and potentially reversible oral inflammation. Furthermore, this research is innovative, because it includes evidence-based interventions for gingivitis reduction, standardized measures of the outcome on lung function and oral microbiome and combines expertise from dentistry, lung physiology, oral microbiology and epidemiology/statistical modelling.

trial registrationGerman Clinical Trial Register DRKS00028176. Registered on February 2022.

Indexed as

GingivitisOral HygieneAdolescentAdultChlorhexidineHumansInflammationLungMouthwashesYoung AdultChlorhexidineMouthwashesGingivitisLung functionMicrobiomeOral healthPeriodontitisSpirometry

Identifiers

PMID36823669
PMCPMC9949689
OpenAlexW4321607219

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.