PeriodontitisNCT07344805
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 study testing AIRFLOW® Prophylaxis Master and Cavitron® ultrasonic scaler in people with Periodontitis, run by Cardenal Herrera University at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- AIRFLOW® Prophylaxis Master and Cavitron® ultrasonic scaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2023to 1 Jul 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have received basic periodontal treatment between 3-6 months before the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad CEU Cardenal Herrera
Alfara del Patriarca, Valencia, 46115
About this study
Official 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
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.
- Conditions
- Periodontitis
- Being tested
- AIRFLOW® Prophylaxis Master, Cavitron® ultrasonic scaler
- Keywords
- periodontal maintenance, erythritol, powder air polishing
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIRFLOW® Prophylaxis MasterDevice
Periodontal Maintenance with Erythritol Air Polisher in periodontal patients.
Cavitron® ultrasonic scalerDevice
Periodontal maintenance with ultrasonic scaler and manual curettes in periodontal patients.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal maintenance with ultrasonic + scaling and root planning | Active comparator | Not described Receives: Device: Cavitron® ultrasonic scaler |
| Periodontal maintenance with erythritol air polishing | Experimental | Not described Receives: Device: AIRFLOW® Prophylaxis Master |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of clinical periodontal parameter: clinical attachment level
Measurement of clinical attachment level in milimeters
Measured: six months
Improvement of clinical periodontal parameter: probing depth
Measurement of probing depth in milimeters
Measured: six months
Improvement of clinical periodontal parameter: bleeding index
Measurement of bleeding index in percentage.
Measured: six months
Secondary outcomes (1)
Changes in periodontal microbiome
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jul 2023
- Primary completion1 Feb 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chirag Sheth, Cardenal Herrera University
- Investigators
- Isidoro Cortell-Ballester, DDS, MD, PhD, Study director, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344805
- Sponsor's protocol ID
- CEU-Martinez-Gonzalez-Cortell
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07344805
- Acronym / sponsor ID
- CEU-Martinez-Gonzalez-Cortell
- Conditions
- Periodontitis
- Keywords
- periodontal maintenance, erythritol, powder air polishing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 15 Jan 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have received basic periodontal treatment between 3-6 months before the study.
Key exclusion criteria (4 listed)
- 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.
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® Prophylaxis MasterPeriodontal Maintenance with Erythritol Air Polisher in periodontal patients. | Device | Periodontal maintenance with erythritol air polishing |
| Cavitron® ultrasonic scalerPeriodontal maintenance with ultrasonic scaler and manual curettes in periodontal patients. | Device | Periodontal maintenance with ultrasonic + scaling and root planning |
Primary outcome
Improvement of clinical periodontal parameter: clinical attachment level
Time frame: six months
Measurement of clinical attachment level in milimeters
Improvement of clinical periodontal parameter: probing depth
Time frame: six months
Measurement of probing depth in milimeters
Improvement of clinical periodontal parameter: bleeding index
Time frame: six months
Measurement of bleeding index in percentage.
1 secondary outcome
Changes in periodontal microbiome
Time frame: Six 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 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Isidoro Cortell-Ballester, DDS, MD, PhD study director
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIRFLOW® Prophylaxis Master and Cavitron® ultrasonic scaler in people with Periodontitis, run by Cardenal Herrera University at 1 site in Spain.
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 1 inclusion and 4 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 Jan 2026. 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 Spain. 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?
Improvement of clinical periodontal parameter: clinical attachment level (time frame: six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2026.