Efficacy of Sub-gingival Air-polishing With Erythritol in the Treatment of Periodontitis (GBT2017)

February 14, 2020 updated by: Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OUTCOME

  1. Primary outcome measure: 3-month change in the number of sites with probing depth (PD) 5-9 mm and positive to bleeding upon probing (BoP). Sites characterized by PD 5-9 mm and BoP+ will be therefore identified as "experimental sites".
  2. Secondary outcomes: 3-month changes in the following clinical parameters assessed at experimental sites: clinical attachment level (CAL), PD, number of sites harboring supra-gingival plaque.
  3. Other evaluations: Pocket microbiological (subgingival plaque) samples at one (interproximal) experimental site for analysis of periodontal pathogens at baseline and 3 months following treatment.

STUDY POPULATION Forty (40) adults, aged 18-75 years, will be entered into study (randomized). It is expected that at least thirty-two (32) subjects will complete the study.

Randomized subjects who deviate from the protocol (major protocol deviation) and, for this reason, are excluded from the analysis, will be replaced to guarantee that the sample required for the analysis (32) is reached.

Inclusion Characteristics

  • Signed Informed Consent Form.
  • Male and female subjects, aged 18-75 years, inclusive.
  • Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
  • Moderate to severe periodontitis
  • At least 8 experimental sites (PD 5-9 mm and BoP+).
  • Availability for the 3-month duration of the study for an assigned subject.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Brescia, Lombardia, Italy, 25124
        • Magda Mensi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed Informed Consent Form.
  • Male and female subjects, aged 18-75 years, inclusive.
  • Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
  • Moderate to severe periodontitis
  • At least 8 experimental sites (PD 5-9 mm and BoP+).
  • Availability for the 3-month duration of the study for an assigned subject.

Exclusion Criteria:

  • Presence of orthodontic appliances.
  • Chronic obstructive pulmonary disease and asthma.
  • Tumors or significant pathology of the soft or hard tissues of the oral cavity.
  • Current radiotherapy or chemotherapy.
  • Pregnant or lactating women.
  • Current or past (within 3 months prior to enrolment) assumption of medications that may influence periodontal conditions and/or interfere with healing following periodontal treatment (i.e., corticosteroids, calcium channel blockers, systemic antibiotics, ...).
  • History of allergy to Erythritol.
  • Restorations on the teeth to be treated which may interfere with treatment administration and/or scoring procedures, at the discretion of the examiner.
  • Non-surgical and/or surgical mechanical/manual periodontal debridement within 3 months prior to enrolment.
  • Use of systemically administered antibacterial agents to treat periodontal disease or dental prophylaxis within 3 months prior to enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guided Biofilm Therapy with Perioflow
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.
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
Active Comparator: Guided Biofilm Therapy without Perioflow
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.
Device: Airflow and Erythritol powder and ultrasonic debridement
Airflow combined with Erythritol powder will be used as an adjunct therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome measure:3 month and to the end of study ( 1 years)
Time Frame: through study completion, an average of 1 year
Sites characterized by PD 5-9 mm and BoP+ will be therefore identified as "experimental sites".
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Collaborators

Università degli Studi di Ferrara

Investigators

  • Principal Investigator: Magda Mensi, ASST Spedali Civili di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2018

Primary Completion (Actual)

October 5, 2019

Study Completion (Actual)

December 10, 2019

Study Registration Dates

First Submitted

June 24, 2019

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 14, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBT2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontitis, Aggressive

Clinical Trials on Perioflow and Erythritol powder and ultrasonic debridement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe