GBT2017
Sponsor study identifier
interventional
40
1 country
1
Study Start
February 28, 2018
Actual (reported)Primary Completion
October 5, 2019
Actual (reported)Study Completion
December 10, 2019
Actual (reported)The first step in the management of periodontal disease involves the non-surgical removal of the soft and hard bacterial deposits at all supra- and sub-gingival sites, especially into deep pockets, which can be carried on with different instruments. Unfortunately it seems that, after the initial therapy, many patients still present with active pockets (residual pockets) requiring further treatment and posing a risk of disease progression. This might be due to limitations of the instruments applied and patient-related factors. Air-polishing with low-abrasiveness powders seems to be very effective in the removal of supra- and sub-gingival biofilm and could provide additional benefits during the treatment of pockets. The hypothesis of the present randomized controlled trial was that the adjunctive use of a sub-gingival nozzle for air-polishing with erythritol powder in pockets with probing depth of 5-9mm and with bleeding (experimental sites) can bring clinical and microbiological advantages during the active therapy of periodontal disease, and reduce the number of residual pockets. To test this hypothesis, the patients, upon initial evaluation, were divided in 2 study groups:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 10, 2019
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 28, 2018
Actual (reported)June 24, 2019
Actual (reported)October 5, 2019
Actual (reported)December 10, 2019
Actual (reported)February 11, 2020
Actual (reported)Primary outcome measure:3 month and to the end of study ( 1 years)
Sites characterized by PD 5-9 mm and BoP+ will be therefore identified as "experimental sites".
through study completion, an average of 1 year
The entire mouth will be treated (supra-/subgingival) in a single session. If the patient has been identified to receive the adjunctive treatment, he/she will also receive subgingival biofilm removal with Perioflow combined with Erythritol powder at sites with PD≥ 5 mm, including the experimental sites, prior to subgingival biofilm removal with USD.
The entire mouth will be treated (supra-/subgingival) in a single session. If the patient has been identified to receive the control treatment, all teeth present will receive the application of disclosing agent, full-mouth supragingival and intra-sulcular biofilm removal with Airflow at sites with PD up to 4 mm, full mouth supra gingival calculus removal with USD, and subgingival biofilm removal with USD at sites with PD\> 4 mm, including the experimental sites, as required.
Airflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy
Airflow combined with Erythritol powder will be used as an adjunct therapy
Magda Mensi
Brescia, Lombardy, 25124, Italy
Mensi M, Caselli E, D'Accolti M, Soffritti I, Farina R, Scotti E, Guarnelli ME, Fabbri C, Garzetti G, Marchetti S, Sordillo A, Trombelli L. Efficacy of the additional use of subgingival air-polishing with erythritol powder in the treatment of periodontitis patients: a randomized controlled clinical trial. Part II: effect on sub-gingival microbiome. Clin Oral Investig. 2023 Jun;27(6):2547-2563. doi: 10.1007/s00784-022-04811-4. Epub 2022 Dec 20.
Mensi M, Scotti E, Sordillo A, Calza S, Guarnelli ME, Fabbri C, Farina R, Trombelli L. Efficacy of the additional use of subgingival air polishing with erythritol powder in the treatment of periodontitis patients: a randomized controlled clinical trial. Clin Oral Investig. 2021 Feb;25(2):729-736. doi: 10.1007/s00784-020-03648-z. Epub 2021 Jan 6.
Magda Mensi
Asst Degli Spedali Civili Di Brescia
40 participants (actual enrollment reported by the registry).
First Submitted
June 24, 2019
First Posted
February 11, 2020
Study Start
February 28, 2018
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 5, 2019
Actual (reported)Study Completion
December 10, 2019
Actual (reported)Last Updated
February 18, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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