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Efficacy of GBT vs SRP+US, in the Treatment of Severe Generalized Periodontitis.

NCT05112471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-11-08

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 aim of this randomized, controlled, split-mouth study was to compare the efficacy of full-mouth air-polishing followed by ultrasonic debridement (GBT) versus traditional Scaling and Root Planing (SRP), in terms of pocket closure in patients with stage III-IV periodontitis.

To test this hypothesis, the mouth of each patients, upon initial evaluation, were divided in 2 parts:

1. The control group undergoing a standard procedure: ultrasonic debridement with an ultrasonic scaler for remove supra and sub gingival calculus, manual debridement with curettes at deep pathological pockets (PPD \> 4mm) and rubber cup with polishing to remove supra gingival biofilm and plaque.
2. The study group undergoing the innovative air polishing procedure: airflow with erythritol powder to remove supra and sub gingival biofilm and plaque, perioflow at deep pathological pockets (PPD \> 4mm) and ultrasonic debridement with an ultrasonic scaler for remove supra and sub gingival calculus.

The prevalence of residual pockets will be evaluated at 6 weeks and 3 months after the initial therapy and compared between the two groups.

Conditions

  • Periodontitis, Aggressive
  • Periodontal Diseases
  • Periodontitis

Interventions

DEVICE

Airflow, Perioflow and Erythritol powder and ultrasonic debridement

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

DEVICE

Ultrasonic debridement and curettes

traditional Scaling and Root Planing with curettes and ultrasonic scaler

Sponsors & Collaborators

  • 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
2016-11-22
Primary Completion
2018-09-04
Completion
2020-04-04

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 NCT05112471 on ClinicalTrials.gov