The Efficacy of Full Mouth Erythritol Powder Air-Polishing Therapy (FM-EPAPT) Versus Traditional Ultrasonic Debridment (UD): a Randomized Controlled Study. (ERICO)

July 13, 2020 updated by: Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Traditional methods for plaque and calculus removal involve the use of mechanical and/or manual instruments, followed by surface polishing with rubber cups and low abrasive pastes. These instruments may cause the unintended removal of hard dental tissue, such as enamel, cementum and dentine, increasing surface roughness. Moreover, they can lead to gingival recession and consequent hypersensitivity and discomfort during treatment. New minimally-invasive approaches to biofilm removal have been recently introduced with the aim to limit the negative impact on the oral tissue. Air-polishing with low-abrasiveness powders are proven suitable for both for supra- and sub-gingival plaque removal. The use of low-abrasiveness powders could lead to several advantages, such as reduction of treatment discomfort, shorter treatment time, the possibility of cleaning areas with difficult access and minor damage on soft and hard tissues.

Aim: the aim of this study is to evaluate the efficacy of the Full Mouth Erithrytol Powder Air-Polishing Therapy compared to traditional ultrasonic debridment (UD) and polishing in patient affected by gingivitis.

Test hypotesis: there is no difference in clinical outcome between two methods against the hypothesis of a difference in terms of changes in Blending on Probing (BOP).

To test this hypothesis, the patients, upon initial evaluation, were treated in split mouth:

  • The control group undergoing the standard procedure with full-mouth ultrasonic debridement and polishing with rubber cup and abrasive paste.
  • The study group undergoing an innovative procedure involving full-mouth air-polishing followed by ultrasonic calculus removal.

Follow-ups are scheduled at 2 weeks and 1, 3, 6 and 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

TRIAL DESIGN:

Mono-centric, pragmatic, double-blinded, randomized clinical trial (RCT) with split-mouth design. The trial will have a one year of duration.

PRIMARY OUTCOME:

- Change in BoP: change in percentage of sites positive to bleeding on probing.

SECONDARY OUTCOMES:

  • Change in Plaque Index (PI): change in percentage of sites with presence of plaque. Baseline values will be compared to the values recorded at follow-up visits.
  • Change in Residual Plaque Area (RPA): Post-treatment percentage of tooth area with residual plaque, visualised via plaque disclosing agent. This will be calculated with computer software analysis (ImageJ) on clinical photographs.
  • Change in Periodontal Attachment Level (PAL): change in mean value for each patient will be calculated. Baseline values will be compared to the values recorded at follow-up visits.
  • Change in (Pocket Probing Depth) PPD: change in mean value for each patient will be calculated. Baseline values will be compared to the values recorded at follow-up visits.
  • Duration of the treatment: calculated in minutes. Time will be recorded starting from the opening the randomisation envelope until the clinician is satisfied with the clinical result.
  • Comfort of the patient: an anonymous questionnaire will be administered at baseline and each recall appointment.
  • Sensation of cleanliness: an anonymous questionnaire will be administered at baseline and each recall appointment.

STUDY POPULATION:

41 Systemically healthy patients affected by gingivitis will be included in this study. Presence of gingivitis is defined as: absence of Probing pocket depth (PPD) > 4mm and presence of BoP >25%.

INCLUSION CRITERIA:

  • Patients affected by gingivitis (BoP >25%);
  • Patients with at least 5 teeth per quadrant;
  • Systemically healthy;
  • Age > 18 years;
  • Smoking less than 10 cigarettes a day.

Study Type

Interventional

Enrollment (Actual)

41

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, 25123
        • 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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of gingivitis (BoP > 25%);
  • Presence of at least 5 teeth per quadrant;
  • Systemically healthy;
  • Age between 20 and 40 years old.

Exclusion Criteria:

  • Presence of periodontal disease, defined as >3 mm of clinical attachment loss at any site;
  • Presence of fixed retainers, orthodontic appliances or complex prothetic restorations;
  • Presence of crowding;
  • Pregnant or lactating;
  • Allergy to chlorhexidine or erythritol;
  • Smoking >10 cigarettes per day;
  • Unwillingness to undergo the proposed treatment and recalls;

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full-Mouth Erythritol Powder Air-polishing Therapy (FM-EPAPT)

The quadrants allocated to FM-EPAPT underwent the following steps:

  • Decontamination of soft tissues with air-polishing and erythritol powder;
  • Supra-gingival removal biofilm with air-polishing and erythritol powder;
  • Sub-gingival removal of biofilm with air-polishing and erythritol;
  • Calculus removal with a piezoceramic scaler.
Device: AIRFLOW® with PLUS® powder and PIEZON® scaler
Air-polishing will be use as main instrument for biofilm and stains removal, followed by ultrasonic scaling
Active Comparator: Ultrasonic debridement and abrasive paste (US+P)

The quadrants allocated to US+P treatment underwent the following steps:

  • Full-mouth ultrasonic debridement with piezoceramic scaler;
  • Plaque removal and polishing with soft rubber cup and low-RDA polishing paste
Device: PIEZON® scaler and rubber cup with abrasive paste
Application of ultrasonic scaler on the entire dentition, followed by residual biofilm and stains removal and polishing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bleeding on Probing (BoP)
Time Frame: study completion, an average of 18 months
Change in percentage of sites positive to bleeding on probing
study completion, an average of 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Plaque Index (PI)
Time Frame: From baseline to study completion (12 months)
Change in percentage of site with plaque. Baseline values will be compared to the values recorded in the follow-up visits.
From baseline to study completion (12 months)
Change in residual plaque area (RPA)
Time Frame: From baseline to study completion (12 months)
Post-treatment residual plaque recorded via plaque disclosing agent, clinical photographs and image software analysis
From baseline to study completion (12 months)
Change in Periodontal Attachment Level (PAL)
Time Frame: From baseline to study completion (12 months)
Change in mean PAL value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.
From baseline to study completion (12 months)
Change in Pocket Probing Depth (PPD)
Time Frame: From baseline to study completion (12 months)
Change in mean PPD value for each patient. Baseline values will be compared to the values recorded in the follow-up visits.
From baseline to study completion (12 months)
Treatment time
Time Frame: From baseline to study completion (12 months)
Calculated in minutes, from the opening of the randomisation envelope to the end of the instrumentation.
From baseline to study completion (12 months)
Comfort of the patient
Time Frame: From baseline to study completion (12 months)
An anonymous questionnaire will be administered at baseline and each recall appointment. The score is on a scale: from 0 to 5, where 0 is the minimum discomfort and 5 the maximum discomfort.
From baseline to study completion (12 months)
Sensation of cleanliness
Time Frame: From baseline to study completion (12 months)
An anonymous questionnaire will be administered at baseline and each recall appointment. The score is on a scale of 5 feelings: insufficient, sufficient, average, good and optimal.
From baseline to study completion (12 months)

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

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)

May 3, 2017

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERICO np: 2637

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.

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