NCT07200284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

August 11, 2025

Last Update Submit

September 26, 2025

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (6)

  • 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.

Study Arms (2)

Control (manual SRP)

ACTIVE COMPARATOR

The gold standard treatment for periodontitis

Procedure: Manual SRP

Airflow

EXPERIMENTAL

An ultrasonic and air-polishing device for periodontal debridement

Procedure: Airpolishing device

Interventions

Airpolishing devicePROCEDURE

The authors will assess biochemical and clinical variables

Also known as: Airflow
Airflow
Manual SRPPROCEDURE

Gold standard

Control (manual SRP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Periodontitis patients

You may not qualify if:

  • Diabetes or other uncontrolled systemic inflammatory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, Spain

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Pulmonary Ventilation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Intern, Dp of Periodontics

Study Record Dates

First Submitted

August 11, 2025

First Posted

October 1, 2025

Study Start

February 1, 2025

Primary Completion

July 1, 2025

Study Completion

August 11, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)