NCT04264624: GBT2017

Efficacy of Sub-gingival Air-polishing With Erythritol in the Treatment of Periodontitis

Completed NA Last updated 18 February 2020

What this trial tests

NA trial testing Perioflow and Erythritol powder and ultrasonic debridement in Periodontitis, Adult in 40 participants. Completed in 10 December 2019.

Timeline

28 February 2018

Primary endpoint
5 October 2019

10 December 2019

Quick facts

Lead sponsor	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	40
Start date	28 February 2018
Primary completion	5 October 2019
Estimated completion	10 December 2019
Sites	1 location across Italy

Drugs / interventions tested

• Perioflow and Erythritol powder and ultrasonic debridement
• Airflow and Erythritol powder and ultrasonic debridement

Conditions studied

• Periodontitis, Adult — all drugs for Periodontitis, Adult →
• Periodontitis, Aggressive — all drugs for Periodontitis, Aggressive →

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — full company profile →

Who can join

Adults 18 to 75, any sex, with Periodontitis, Adult or Periodontitis, Aggressive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

1. The control group, undergoing a standard procedure involving air-polishing supra-gingivally and at healthy sub-gingival sites followed by debridement with an ultrasonic scaler at deep pathological pockets
2. The study group, undergoing the same procedure but with the additional use of a sub-gingival nozzle at deep pathological pockets.

The healing of the experimental sites and the prevalence of residual pockets will be evaluated at 3 months after the initial therapy and compared between the two groups.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of the additional use of subgingival air polishing with erythritol powder in the treatment of periodontitis patients: a randomized controlled clinical trial.
   Mensi M, Scotti E, Sordillo A, Calza S, et al · · 2021 · cited 19× · PMID 33404760 · DOI 10.1007/s00784-020-03648-z
2. 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.
   Mensi M, Caselli E, D'Accolti M, Soffritti I, et al · · 2023 · cited 10× · PMID 36538094 · DOI 10.1007/s00784-022-04811-4