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

Gingivitis Clinical Trial

— ERICO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455269
• Other study ID #: ERICO np: 2637
• Status: Completed
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: July 2020
• Source: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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;

Related Conditions & MeSH terms

• Gingivitis

Intervention

Device:
• AIRFLOW® with PLUS® powder and PIEZON® scaler
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
Application of ultrasonic scaler on the entire dentition, followed by residual biofilm and stains removal and polishing

Locations

Country	Name	City	State
Italy	Magda Mensi	Brescia	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Bühler 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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.2 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bleeding on Probing (BoP)	Change in percentage of sites positive to bleeding on probing	study completion, an average of 18 months
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)