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Completed

NCT Number: NCT04455269

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

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magda Mensi

Brescia, Lombardy, 25123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

AIRFLOW® with PLUS® powder and PIEZON® scaler

Device

Air-polishing will be use as main instrument for biofilm and stains removal, followed by ultrasonic scaling

PIEZON® scaler and rubber cup with abrasive paste

Device

Application of ultrasonic scaler on the entire dentition, followed by residual biofilm and stains removal and polishing

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Acronym: ERICO

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2020
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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