Clinical Effects and Metagenomic Analysis of Using an Air Polishing Device With Erythritol Powder Compared to Scaling and Root Planing in Periodontal Maintenance Therapy.

January 8, 2026 updated by: Chirag Sheth, Cardenal Herrera University

Clinical Effects and Metagenomic Analysis of Using an Air Polishing Device With Erythritol Powder Compared to Scaling and Root Planing in Periodontal Maintenance Therapy: A Randomized Clinical Trial

Periodontitis is a chronic, multifactorial disease primarily driven by the accumulation of bacterial deposits. Treatment involves the mechanical removal of the biofilm, traditionally performed by scaling and root planing (SRP). However, SRP is time-consuming and can cause irreversible damage to both hard and soft tissues as well as postoperative sensitivity. Consequently, adjunctive or alternative air-polishing devices have been developed. The objective of this study is to compare the clinical and microbiological efficacy of an erythritol-powder air-polishing device versus SRP in periodontal maintenance therapy.To evaluate patient-reported pain and treatment time for erythritol air-polishing versus SRP. A randomized clinical trial was designed and participants were randomly assigned to one of two groups: Intervention: Perio-Flow® (air + erythritol powder) and PIEZON PS®. Control: Ultrasonic debridement followed by SRP with Gracey curettes.At baseline and at six months, probing depth, clinical attachment level, and bleeding on probing were recorded. Saliva samples were collected to detect the most prevalent periodontal pathogens. Patient discomfort during treatment was measured by a visual analog scale, and procedure duration was timed.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Valencia
      • Alfara del Patriarca, Valencia, Spain, 46115
        • Universidad CEU Cardenal Herrera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have received basic periodontal treatment between 3-6 months before the study.

Exclusion Criteria:

  • Pregnant or breastfeeding patients.
  • Use of systemic antibiotics within 6 months prior to the study.
  • Patients who smoke more than 10 cigarettes/day.
  • Uncontrolled diabetic patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Periodontal maintenance with ultrasonic + scaling and root planning
Periodontal maintenance with ultrasonic scaler and manual curettes in periodontal patients.
Experimental: Periodontal maintenance with erythritol air polishing
Periodontal Maintenance with Erythritol Air Polisher in periodontal patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of clinical periodontal parameter: clinical attachment level
Time Frame: six months
Measurement of clinical attachment level in milimeters
six months
Improvement of clinical periodontal parameter: probing depth
Time Frame: six months
Measurement of probing depth in milimeters
six months
Improvement of clinical periodontal parameter: bleeding index
Time Frame: six months
Measurement of bleeding index in percentage.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in periodontal microbiome
Time Frame: Six months

We will present the following analyses:

  • Overall and differential abundance
  • Comparative relative inter-group community structure differences

The overall and differential abundance of taxa will be analyzed using Kruskal Wallis non-parametric test. FDR Benjamini-Hochberg correction will be used to correct for multiple comparisons.

Differences in community structure between experimental and control groups will be tested using Permanova. Permdisp test will be used to identify location vs. dispersion effects .

The threshold for significance for all analyses will be set at p ≤ 0.05.

'BiodiversityR' version 2.11-1, 'PMCMR' version 4.3 and 'vegan' version 2.5-5 packages of the R software package version 36.6.0 (www.R-project.org) will be used.

Six months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient discomfort
Time Frame: Six months
Measurement of patient discomfort during the treatment by Visual Analogue Scale (VAS) Questionnaire (from no pain (score 0) to maximum pain imaginable (score 7)).
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Isidoro Cortell-Ballester, DDS, MD, PhD, Cardenal Herrera University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

February 1, 2025

Study Completion (Actual)

July 1, 2025

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CEU-Martinez-Gonzalez-Cortell

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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