Methodological issues in randomized trials assessing probiotics for periodontal treatment

BACKGROUND AND OBJECTIVE: Probiotics traditionally used in medicine field are now being used in an attempt to control and treat periodontal disease. However, the trials used to analyze the effects of probiotics have been subject to methodological criticism. The aim of this review was to assess the methodological deficiencies in randomized controlled trials evaluating the efficacy and safety of oral administration of probiotics for the treatment of periodontal disease.

MATERIAL AND METHODS: A manual and electronic literature search (of MEDLINE and The Cochrane Library) was made, to March 2011, for randomized controlled trials presenting clinical, microbiological, immunological and patient-centered data for the efficacy of probiotics compared with a placebo/standard periodontal therapy for the treatment of periodontal disease.

RESULTS: The literature search yielded only four randomized double-blind, placebo-controlled studies that evaluated the efficacy of probiotics (using Lactobacillus reuteri and Lactobacillus salivarius probiotic strains) in patients with gingivitis. The studies were too methodologically flawed (of mediocre quality) with a high risk of bias for any meaningful conclusions to be reached. These studies lacked adequate descriptions of appropriate randomization, allocation concealment, blinding, formulation and dosage of probiotic and placebo, extent and severity of periodontal disease in patient populations, patient-centered outcomes, results data and potential confounding factors.

CONCLUSION: The existing randomized controlled trials have important methodological limitations; consequently, there is insufficient evidence to support the efficacy of probiotics in treating periodontal disease. More rigorous scientific research, in accordance with existing guidelines and research recommendations of the present review, is required to examine the safety and efficacy of probiotics before they are embraced in periodontal therapy.

Contributors

Dhingra, K.

Publication

Journal: Journal of Periodontal Research
Volume: 47
Issue: 1
Pages: 15 - 26
Year: 2012
DOI: 10.1111/j.1600-0765.2011.01399.x

Further Study Information

Current Stage: Not Applicable
Date:
Funding source(s): None stated.


Health Area

Disease Category: Dentistry & oral health

Disease Name: Periodontal disease

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Diet and nutrition

Stakeholders Involved

- None

Study Type

- Recommendations made
- Systematic review of outcomes measured in trials

Method(s)

- Systematic review

The PubMed (MEDLINE) database of the US National Library of Medicine and The Cochrane Library of the Cochrane Collaboration (CENTRAL) were utilized as the electronic databases and a literature search was accomplished on articles published in English from 1990 to March 2011. Articles available online in electronic form before their publication in material form (according to the so-called ‘Epub ahead of print’ or ‘early online Articles’) were considered eligible for inclusion in this review. The electronic search was carried out by applying the MeSH terms. In addition, a hand search (up to March 2011) of the following journals was performed: Journal of Periodontology, Journal of Clinical Periodontology, Journal of Periodontal Research, Molecular Oral Microbiology, Oral Diseases and Periodontology 2000.

The reference lists of review articles were scanned and the reference lists of articles selected for inclusion in the present review were screened. Reports were included only if the study design was identified as an RCT, if it was published as a full-text article, if blinded evaluation was implemented and if the effect (clinical, microbiological, immunological and patient-centered outcomes) of oral administration of probiotic was compared with administration of a placebo or standard periodontal therapy in the treatment of gingivitis and chronic and aggressive periodontitis. Case series, uncontrolled studies and articles published as abstract only, editorials, news and correspondence sections were excluded.

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