Periodontal Air-Polishing Device Versus Manual Scaling and Root Planing

Not Applicable

Completed

• Conditions: Periodontitis

• Registration Number: NCT07200284
• Lead Sponsor: Universidad de Granada

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-11
• Study First Submitted: 2025-08-11
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Periodontitis patients

Exclusion Criteria

• Diabetes or other uncontrolled systemic inflammatory diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 (%)
Periodontal Pocket Depth (PPD)	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)
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)
Biochemical variables	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)
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)
Visible Plaque Index (VPI)	Pre-treatment and 4-6 weeks after treatment.	Description: Proportion of sites with visible plaque. Unit of Measure: Percentage (%)

Trial Locations

Locations (1)

University of Granada; 🇪🇸 Granada, Spain