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

NCT04264624 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-02-18

No results posted yet for this study

Summary

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.

Conditions

  • Periodontitis, Adult
  • Periodontitis, Aggressive

Interventions

DEVICE

Perioflow and Erythritol powder and ultrasonic debridement

Airflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy

DEVICE

Airflow and Erythritol powder and ultrasonic debridement

Airflow combined with Erythritol powder will be used as an adjunct therapy

Sponsors & Collaborators

  • Università degli Studi di Ferrara

    collaborator OTHER

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    lead OTHER

Principal Investigators

  • Magda Mensi · ASST Spedali Civili di Brescia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2019-10-05
Completion
2019-12-10

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04264624 on ClinicalTrials.gov