Does a probiotic (L. reuteri) lozenge taken twice daily over 3-4 weeks reduce probing pocket depth in patients with chronic periodontitis after 3 months? A systematic review of clinical trials (Protocol)

Abstract

Introduction: Chronic periodontitis is a slow progressing, multifactorial inflammatory disease of the periodontium that may lead to its destruction, which is detectable as increasing probing pocket depth (PPD), subsequent tooth mobility and tooth loss. The purpose of this systematic review is to update and appraise the current trial evidence to the question do probiotic (L. reuteri) lozenge taken twice daily over 3 to 4 weeks reduce probing pocket depth in patients with chronic periodontitis after 3 months. Methods and analysis: We will conduct reference checks of previous systematic review and trial reports to the topic. PubMed, Scopus, Cochrane library and the Directory of Open Access Journals (DOAJ) will be searched. All selected trial reports will be independently appraised by two reviewers, using the CQS2B trial appraisal tool. Metaanalysis will be conducted using a random effect model with inverse variance method, stratified according to CQS2B corroboration levels (C1 to 4). The I square test with 95% Confidence Interval will be used to establish whether any statistical heterogeneity between datasets exist. Sensitivity analysis will be conducted for metaanalysis results of trials that were rated with onescore at all four CQS2B appraisal criteria, by excluding trials in which: Patients were smokers; Patients were Type II diabetics; Adjunctive antibiotic therapy was provided. For meta-analyses including data of at least four trials, which have been rated with a 1-score for all four appraisal criteria, the results will be further statistically tested for possible selection bias. Publication bias risk will be quantitatively assessed by use of Eggers regression. Ethics and dissemination: Ethical approval is not required for literature-based studies. The results will be disseminated as a prior preprint version and subsequent peer-reviewed publication.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present work are contained in the manuscript

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