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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (manual SRP) | Active Comparator | The gold standard treatment for periodontitis |
|
| Airflow | Experimental | An ultrasonic and air-polishing device for periodontal debridement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airpolishing device | Procedure | The authors will assess biochemical and clinical variables |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on Probing (BOP) | Description: Proportion of sites showing bleeding upon gentle probing. Unit of Measure: Percentage (%) | 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) | 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) | 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) | 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) | Pre-treatment and 4-6 weeks after treatment. |
| Visible Plaque Index (VPI) | Description: Proportion of sites with visible plaque. Unit of Measure: Percentage (%) | Pre-treatment and 4-6 weeks after treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Granada | Granada | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 1, 2025 | Sep 19, 2025 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012123 | Pulmonary Ventilation |
| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Manual SRP | Procedure | Gold standard |
|
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |