Skip to main content
OpenTrials
Completed

NCT Number: NCT07344805

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad CEU Cardenal Herrera

Alfara del Patriarca, Valencia, 46115, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AIRFLOW® Prophylaxis Master

Device

Periodontal Maintenance with Erythritol Air Polisher in periodontal patients.

Cavitron® ultrasonic scaler

Device

Periodontal maintenance with ultrasonic scaler and manual curettes in periodontal patients.

Primary outcomes

  1. Improvement of clinical periodontal parameter: clinical attachment level

    Time frame: six months

    Measurement of clinical attachment level in milimeters

  2. Improvement of clinical periodontal parameter: probing depth

    Time frame: six months

    Measurement of probing depth in milimeters

  3. Improvement of clinical periodontal parameter: bleeding index

    Time frame: six months

    Measurement of bleeding index in percentage.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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)).

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.