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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:
Follow-ups are scheduled at 2 weeks and 1, 3, 6 and 12 months.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-Mouth Erythritol Powder Air-polishing Therapy (FM-EPAPT) | Experimental | The quadrants allocated to FM-EPAPT underwent the following steps:
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| Ultrasonic debridement and abrasive paste (US+P) | Active Comparator | The quadrants allocated to US+P treatment underwent the following steps:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIRFLOWĀ® with PLUSĀ® powder and PIEZONĀ® scaler | Device | Air-polishing will be use as main instrument for biofilm and stains removal, followed by ultrasonic scaling |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magda Mensi | Asst Degli Spedali Civili Di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magda Mensi | Brescia | Lombardy | 25123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23724545 | Result | Draenert ME, Jakob M, Kunzelmann KH, Hickel R. The prevalence of tooth hypersensitivity following periodontal therapy with special reference to root scaling. A systematic review of the literature. Am J Dent. 2013 Feb;26(1):21-7. | |
| 25619863 | Result | Buhler J, Amato M, Weiger R, Walter C. A systematic review on the patient perception of periodontal treatment using air polishing devices. Int J Dent Hyg. 2016 Feb;14(1):4-14. doi: 10.1111/idh.12119. Epub 2015 Jan 23. |
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Mono-centric, double-blinded, randomized clinical trial (RCT) with a split-mouth design.
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Clinical examination, collection of periodontal parameters and clinical photographs were performed by the same trained dentist blinded to the treatment.
| PIEZONĀ® 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 |
|
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) |
| 21861637 | Result | Flemmig TF, Arushanov D, Daubert D, Rothen M, Mueller G, Leroux BG. Randomized controlled trial assessing efficacy and safety of glycine powder air polishing in moderate-to-deep periodontal pockets. J Periodontol. 2012 Apr;83(4):444-52. doi: 10.1902/jop.2011.110367. Epub 2011 Aug 23. |
| 28390211 | Result | Camboni S, Donnet M. Tooth Surface Comparison after Air Polishing and Rubber Cup: A Scanning Electron Microscopy Study. J Clin Dent. 2016 Mar;27(1):13-18. |
| 29532597 | Result | Kim SY, Kang MK, Kang SM, Kim HE. Effects of ultrasonic instrumentation on enamel surfaces with various defects. Int J Dent Hyg. 2018 May;16(2):219-224. doi: 10.1111/idh.12339. Epub 2018 Mar 13. |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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