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Periodontal Air-Polishing Device Versus Manual Scaling and Root Planing

Periodontal Air-Polishing Device Reduces Tissue Damage and Improves Clinical Outcomes and Exosomal Modulation. A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07200284
Enrollment
36
Registered
2025-10-01
Start date
2025-02-01
Completion date
2025-08-11
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Brief 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). 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.

Interventions

PROCEDUREAirpolishing device

The authors will assess biochemical and clinical variables

PROCEDUREManual SRP

Gold standard

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Periodontitis patients

Exclusion criteria

* Diabetes or other uncontrolled systemic inflammatory diseases

Design outcomes

Primary

MeasureTime frameDescription
Bleeding on Probing (BOP)Pre-treatment and Re-Evaluation (4-6 weeks after treatment)Description: Proportion of sites showing bleeding upon gentle probing. Unit of Measure: Percentage (%)
Biochemical variablesPre-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)Pre.treatment and 4-6 weeks after treatmentDescription: Depth of periodontal pockets measured at six sites per tooth using a PCPUNC-15 probe. Unit of Measure: Millimeters (mm)
Clinical Attachment Loss (CAL)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)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)Pre-treatment and 4-6 weeks after treatment.Description: Proportion of sites with visible plaque. Unit of Measure: Percentage (%)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026