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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Gingivitis

Intervention / Treatment
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* Device: AIRFLOW® with PLUS® powder and PIEZON® scaler
* Device: PIEZON® scaler and rubber cup with abrasive paste


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Mono-centric, double-blinded, randomized clinical trial (RCT) with a split-mouth design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full-Mouth Erythritol Powder Air-polishing Therapy (FM-EPAPT)<br>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<br>* Air-polishing will be use as main instrument for biofilm and stains removal, followed by ultrasonic scaling<br>|
| Active Comparator: Ultrasonic debridement and abrasive paste (US+P)<br>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<br>* Application of ultrasonic scaler on the entire dentition, followed by residual biofilm and stains removal and polishing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bleeding on Probing (BoP) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingivitis, GBT, Ultrasonic debridement