PeriodontitisNCT07200284
Periodontal Air-Polishing Device Versus Manual Scaling and Root Planing
A study testing Airpolishing device and Manual SRP in people with Periodontitis, run by Universidad de Granada at 1 site in Spain.
Trial summary
This study looks at two common ways to perform deep cleaning of the gums in people with periodontitis: Airflow® (a spray system that uses fine powder and water) and hand scaling (cleaning with metal instruments). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Airpolishing device and Manual SRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2025to 11 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontitis patients
Who cannot join
- Diabetes or other uncontrolled systemic inflammatory diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periodontal Air-Polishing Device Reduces Tissue Damage and Improves Clinical Outcomes and Exosomal Modulation. A Randomized Clinical Trial
This study looks at two common ways to perform deep cleaning of the gums in people with periodontitis: Airflow® (a spray system that uses fine powder and water) and hand scaling (cleaning with metal instruments). The investigators want to see how each treatment affects inflammation at the molecular level by measuring exosomes (tiny particles released by cells that carry signals) and cytokines (proteins that help regulate inflammation) in the fluid around the gums.
Participants will receive one of the two standard treatments and will have samples taken from the mouth (saliva and/or gum fluid) at specific times before and after treatment. The authors will also record clinical measurements such as bleeding, gum pocket depth, and attachment loss, as well as simple questionnaires about symptoms.
- Conditions
- Periodontitis
- Being tested
- Airpolishing device, Manual SRP
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airpolishing deviceProcedure or surgery
Also called Airflow
The authors will assess biochemical and clinical variables
Manual SRPProcedure or surgery
Gold standard
| Study group | Role | What they receive |
|---|---|---|
| Control (manual SRP) | Active comparator | The gold standard treatment for periodontitis Receives: Procedure: Manual SRP |
| Airflow | Experimental | An ultrasonic and air-polishing device for periodontal debridement Receives: Procedure: Airpolishing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing (BOP)
Description: Proportion of sites showing bleeding upon gentle probing. Unit of Measure: Percentage (%)
Measured: Pre-treatment and Re-Evaluation (4-6 weeks after treatment)
Biochemical variables
Concentration of exosomes and cytokines using a commercial kit, measured in pg/mL. Gingival Crevicular Fluid will be obtained using the Mombelli technique (introducing an absorbent paper point inside the periodontal pocket)
Measured: Pre-treatment and Re-Evaluation (4-6 weeks after treatment).
Periodontal Pocket Depth (PPD)
Description: Depth of periodontal pockets measured at six sites per tooth using a PCPUNC-15 probe.
Unit of Measure: Millimeters (mm)
Measured: Pre.treatment and 4-6 weeks after treatment
Clinical Attachment Loss (CAL)
Description: Distance from the cementoenamel junction to the base of the pocket.
Unit of Measure: Millimeters (mm)
Measured: Pre-treatment and 4-6 weeks after treatment.
Periodontal Inflammation Severity Index (PIRIM, modified)
Description: Calculated as the sum of periodontal pocket depth, normalized by the number of teeth.
Unit of Measure: Index score (continuous variable, unitless)
Measured: Pre-treatment and 4-6 weeks after treatment.
Visible Plaque Index (VPI)
Description: Proportion of sites with visible plaque. Unit of Measure: Percentage (%)
Measured: Pre-treatment and 4-6 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Feb 2025
- Primary completion1 Jul 2025
- Study completion11 Aug 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Bonilla, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200284
- Sponsor's protocol ID
- 4566/CEIH/2024
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Air-Polishing Device Reduces Tissue Damage and Improves Clinical Outcomes and Exosomal Modulation. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07200284
- Acronym / sponsor ID
- 4566/CEIH/2024
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 1 Oct 2025 (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.
This study looks at two common ways to perform deep cleaning of the gums in people with periodontitis: Airflow® (a spray system that uses fine powder and water) and hand scaling (cleaning with metal instruments). The investigators want to see how each treatment affects inflammation at the molecular level by measuring exosomes (tiny particles released by cells that carry signals) and cytokines (proteins that help regulate inflammation) in the fluid around the gums.
Participants will receive one of the two standard treatments and will have samples taken from the mouth (saliva and/or gum fluid) at specific times before and after treatment. The authors will also record clinical measurements such as bleeding, gum pocket depth, and attachment loss, as well as simple questionnaires about symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (manual SRP) | Active comparator | Procedure: Manual SRPThe gold standard treatment for periodontitis |
| Airflow | Experimental | Procedure: Airpolishing deviceAn ultrasonic and air-polishing device for periodontal debridement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Periodontitis patients
Key exclusion criteria (1 listed)
- Diabetes or other uncontrolled systemic inflammatory diseases
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 |
|---|---|---|
| Airpolishing deviceAlso: AirflowThe authors will assess biochemical and clinical variables | Procedure or surgery | Airflow |
| Manual SRPGold standard | Procedure or surgery | Control (manual SRP) |
Primary outcome
Bleeding on Probing (BOP)
Time frame: Pre-treatment and Re-Evaluation (4-6 weeks after treatment)
Description: Proportion of sites showing bleeding upon gentle probing. Unit of Measure: Percentage (%)
Biochemical variables
Time frame: Pre-treatment and Re-Evaluation (4-6 weeks after treatment).
Concentration of exosomes and cytokines using a commercial kit, measured in pg/mL. Gingival Crevicular Fluid will be obtained using the Mombelli technique (introducing an absorbent paper point inside the periodontal pocket)
Periodontal Pocket Depth (PPD)
Time frame: Pre.treatment and 4-6 weeks after treatment
Description: Depth of periodontal pockets measured at six sites per tooth using a PCPUNC-15 probe. Unit of Measure: Millimeters (mm)
Clinical Attachment Loss (CAL)
Time frame: Pre-treatment and 4-6 weeks after treatment.
Description: Distance from the cementoenamel junction to the base of the pocket. Unit of Measure: Millimeters (mm)
Periodontal Inflammation Severity Index (PIRIM, modified)
Time frame: Pre-treatment and 4-6 weeks after treatment.
Description: Calculated as the sum of periodontal pocket depth, normalized by the number of teeth. Unit of Measure: Index score (continuous variable, unitless)
Visible Plaque Index (VPI)
Time frame: Pre-treatment and 4-6 weeks after treatment.
Description: Proportion of sites with visible plaque. Unit of Measure: Percentage (%)
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 1 Oct 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airpolishing device and Manual SRP in people with Periodontitis, run by Universidad de Granada 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 1 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 1 Oct 2025. 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?
Bleeding on Probing (BOP) (time frame: Pre-treatment and Re-Evaluation (4-6 weeks after treatment)). The study lists 6 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 1 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.