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Completed

NCT Number: NCT07200284

Periodontal Air-Polishing Device Versus Manual Scaling and Root Planing

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Periodontitis patients

Exclusion criteria

  • Diabetes or other uncontrolled systemic inflammatory diseases

Treatment and study plan

Airpolishing device

Procedure

The authors will assess biochemical and clinical variables

Other names: Airflow

Manual SRP

Procedure

Gold standard

Primary outcomes

  1. 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 (%)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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 (%)

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

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.

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