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

NCT04455269 | Completed DMC

• 1 other identifier: ERICO np: 2637
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Keywords

Gingivitis; GBT; Ultrasonic debridement

Outcome Measures

Primary Outcomes (1)

• Change in Bleeding on Probing (BoP)

  Change in percentage of sites positive to bleeding on probing

  study completion, an average of 18 months

Secondary Outcomes (7)

• Change in Plaque Index (PI)

  From baseline to study completion (12 months)

• Change in residual plaque area (RPA)

  From baseline to study completion (12 months)

• Change in Periodontal Attachment Level (PAL)

  From baseline to study completion (12 months)

• Change in Pocket Probing Depth (PPD)

  From baseline to study completion (12 months)

• Treatment time

  From baseline to study completion (12 months)

Study Arms (2)

Full-Mouth Erythritol Powder Air-polishing Therapy (FM-EPAPT)

EXPERIMENTAL

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

Ultrasonic debridement and abrasive paste (US+P)

ACTIVE COMPARATOR

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

Interventions

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

Full-Mouth Erythritol Powder Air-polishing Therapy (FM-EPAPT)

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

Ultrasonic debridement and abrasive paste (US+P)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Magda Mensi

Brescia, Lombardy, 25123, Italy

Location

Related Publications (5)

• 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.

  PMID: 23724545 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.

  PMID: 25619863 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.

  PMID: 21861637 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.

  PMID: 28390211 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.

  PMID: 29532597 RESULT

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Magda Mensi

  ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Clinical examination, collection of periodontal parameters and clinical photographs were performed by the same trained dentist blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

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

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: May 3, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)