GingivitisERICONCT04455269

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

A study testing AIRFLOW® with PLUS® powder and PIEZON® scaler and PIEZON® scaler and rubber cup with abrasive paste in people with Gingivitis, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Gingivitis
What is being tested?: AIRFLOW® with PLUS® powder and PIEZON® scaler and PIEZON® scaler and rubber cup with abrasive paste
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteItaly
Study dates: 3 May 2017to 1 Apr 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

Italy1 site

Magda Mensi
Brescia, Lombardy, 25123

Other trials in Italy

About this study

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.

Read the 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.

Conditions: Gingivitis
Being tested: AIRFLOW® with PLUS® powder and PIEZON® scaler, PIEZON® scaler and rubber cup with abrasive paste
Keywords: Gingivitis, GBT, Ultrasonic debridement
Medical subject headings: Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AIRFLOW® with PLUS® powder and PIEZON® scalerDevice
Air-polishing will be use as main instrument for biofilm and stains removal, followed by ultrasonic scaling
PIEZON® scaler and rubber cup with abrasive pasteDevice
Application of ultrasonic scaler on the entire dentition, followed by residual biofilm and stains removal and polishing

Study groups in NCT04455269
Study group	Role	What they receive
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. Receives: 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 Receives: Device: PIEZON® scaler and rubber cup with abrasive paste

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Bleeding on Probing (BoP)
Change in percentage of sites positive to bleeding on probing
Measured: study completion, an average of 18 months

Secondary outcomes (7)

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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to study completion (12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 20171 Apr 2019

First posted2 Jul 2020
Study start3 May 2017
Primary completion1 Apr 2019
Study completion1 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for GingivitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Mono-centric, double-blinded, randomized clinical trial (RCT) with a split-mouth design.
Masking: Single blind
Who is masked: Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04455269
Sponsor's protocol ID: ERICO np: 2637
Acronym: ERICO
Status last verified: Jul 2020
First submitted: 29 Jun 2020
Last updated: 15 Jul 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 23724545
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.
PubMed 25619863
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.
PubMed 21861637
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.
PubMed 28390211
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.
PubMed 29532597

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
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Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
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All Gingivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Full Mouth Erythritol Powder Air-Polishing Therapy (FM-EPAPT) Versus Traditional Ultrasonic Debridment (UD): a Randomized Controlled Study.
ClinicalTrials.gov ID: NCT04455269
Acronym / sponsor ID: ERICO / ERICO np: 2637
Conditions: Gingivitis
Keywords: Gingivitis, GBT, Ultrasonic debridement
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
Study start: 3 May 2017 (actual)
Primary completion: 1 Apr 2019 (actual)
Study completion: 1 Apr 2019 (actual)
First posted: 2 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: Mono-centric, double-blinded, randomized clinical trial (RCT) with a split-mouth design.

Arm	Type	Receives
Full-Mouth Erythritol Powder Air-polishing Therapy (FM-EPAPT)	Experimental	Device: AIRFLOW® with PLUS® powder and PIEZON® scalerThe 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.
Ultrasonic debridement and abrasive paste (US+P)	Active comparator	Device: PIEZON® scaler and rubber cup with abrasive pasteThe 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

Who may qualify

Ages: 20 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AIRFLOW® with PLUS® powder and PIEZON® scalerAir-polishing will be use as main instrument for biofilm and stains removal, followed by ultrasonic scaling	Device	Full-Mouth Erythritol Powder Air-polishing Therapy (FM-EPAPT)
PIEZON® scaler and rubber cup with abrasive pasteApplication of ultrasonic scaler on the entire dentition, followed by residual biofilm and stains removal and polishing	Device	Ultrasonic debridement and abrasive paste (US+P)

Primary outcome

Change in Bleeding on Probing (BoP)
Time frame: study completion, an average of 18 months
Change in percentage of sites positive to bleeding on probing

7 secondary outcomes

Change in Plaque Index (PI)
Time frame: From baseline to study completion (12 months)
Change in residual plaque area (RPA)
Time frame: From baseline to study completion (12 months)
Change in Periodontal Attachment Level (PAL)
Time frame: From baseline to study completion (12 months)
Change in Pocket Probing Depth (PPD)
Time frame: From baseline to study completion (12 months)
Treatment time
Time frame: From baseline to study completion (12 months)
Comfort of the patient
Time frame: From baseline to study completion (12 months)
Sensation of cleanliness
Time frame: From baseline to study completion (12 months)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
Results publication: PubMed 23724545Draenert 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.
Results publication: PubMed 25619863Buhler 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.
Results publication: PubMed 21861637Flemmig 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.
Results publication: PubMed 28390211Camboni 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.
Results publication: PubMed 29532597Kim 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.
Individual participant dataSharing planned: No

Related trials for Gingivitis

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Magda Mensi principal investigator

Asst Degli Spedali Civili Di Brescia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Bleeding on Probing (BoP) (time frame: study completion, an average of 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04455269, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.