NCT07344805

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

November 19, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

periodontal maintenanceerythritolpowder air polishing

Outcome Measures

Primary Outcomes (3)

  • Improvement of clinical periodontal parameter: clinical attachment level

    Measurement of clinical attachment level in milimeters

    six months

  • Improvement of clinical periodontal parameter: probing depth

    Measurement of probing depth in milimeters

    six months

  • Improvement of clinical periodontal parameter: bleeding index

    Measurement of bleeding index in percentage.

    six months

Secondary Outcomes (1)

  • Changes in periodontal microbiome

    Six months

Other Outcomes (1)

  • Patient discomfort

    Six months

Study Arms (2)

Periodontal maintenance with ultrasonic + scaling and root planning

ACTIVE COMPARATOR
Device: Cavitron® ultrasonic scaler

Periodontal maintenance with erythritol air polishing

EXPERIMENTAL
Device: AIRFLOW® Prophylaxis Master

Interventions

Periodontal Maintenance with Erythritol Air Polisher in periodontal patients.

Periodontal maintenance with erythritol air polishing

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

Periodontal maintenance with ultrasonic + scaling and root planning

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU Cardenal Herrera

Alfara del Patriarca, Valencia, 46115, Spain

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Isidoro Cortell-Ballester, DDS, MD, PhD

    Cardenal Herrera University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 19, 2025

First Posted

January 15, 2026

Study Start

July 1, 2023

Primary Completion

February 1, 2025

Study Completion

July 1, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations