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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04455269
Acronym
ERICO
Enrollment
41
Registered
2020-07-02
Start date
2017-05-03
Completion date
2019-04-01
Last updated
2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis

Keywords

Gingivitis, GBT, Ultrasonic debridement

Brief summary

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.

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.

Interventions

DEVICEAIRFLOW® with PLUS® powder and PIEZON® scaler

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

DEVICEPIEZON® scaler and rubber cup with abrasive paste

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

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

Clinical examination, collection of periodontal parameters and clinical photographs were performed by the same trained dentist blinded to the treatment.

Intervention model description

Mono-centric, double-blinded, randomized clinical trial (RCT) with a split-mouth design.

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
Change in Bleeding on Probing (BoP)study completion, an average of 18 monthsChange in percentage of sites positive to bleeding on probing

Secondary

MeasureTime frameDescription
Change in residual plaque area (RPA)From baseline to study completion (12 months)Post-treatment residual plaque recorded via plaque disclosing agent, clinical photographs and image software analysis
Change in Periodontal Attachment Level (PAL)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.
Change in Pocket Probing Depth (PPD)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.
Change in Plaque Index (PI)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.
Comfort of the patientFrom 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.
Sensation of cleanlinessFrom 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.
Treatment timeFrom baseline to study completion (12 months)Calculated in minutes, from the opening of the randomisation envelope to the end of the instrumentation.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026