NCT05263622

Guided Biofilm Therapy for Periodontal Patients.

Guided Biofilm Therapy for Periodontal Patients Using Two Different Devices: a Split-mouth Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Periodontal patients will be treated with Guided Biofilm Therapy. At the baseline (T0), the following clinical indices will be collected: BoP, BS, CAL, PPD. A plaque disclosing agents will be used to instruct the patients to proper oral hygiene procedures. At this stage, using a split-mouth design, quadrants will be randomized to: * Airflow and Scaling and calculus removal with EMS Prophylaxis Master handpiece * Airflow and calculus removal with Mectron Combi handpiece Patients will be visited after 1 month (T1) and 2 months (T2), in which the periodontal indexes will be collected again. After all the procedures, VAS for pain will be assessed, with Schiff Air Index, comfort (patients), comfort (operator), timing for the procedures (minutes), satisfaction questionnaire (for patients and for the operator), consumption of the powders for the two handpiece.

Detailed description

Periodontal patients that respond to the inclusion criteria and agree to participate in the study will be treated with Guided Biofilm Therapy. At the baseline (T0), the following clinical indices will be collected: BoP, BS, CAL, PPD. A plaque disclosing agents will be used to instruct the patients to proper oral hygiene procedures. At this stage, using a split-mouth design, quadrants will be randomized to: * Airflow and calculus removal with EMS Prophylaxis Master handpiece * Airflow and calculus removal with Mectron Combi handpiece Patients will be visited after 1 month (T1) and 2 months (T2), in which the periodontal indexes will be collected again. Together with periodontal assessment, VAS for pain will be assessed, with Schiff Air Index, comfort (patients), comfort (operator), timing for the procedures (minutes), satisfaction questionnaire (for patients and for the operator), consumption of the powders for the two handpieces.

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
OTHER	Split-mouth administration for group B	* Plaque disclosing agent application and instructions to patients for a correct oral hygiene; * Airflow deplaquing with EMS handpiece (quadrants Q1 and Q3) and with Mectron handpiece (quadrants Q2 and Q4) * Calculus removal with EMS ultrasound handpiece (Q1 and Q3) and with Mectron handpiece (Q2 and Q4)
OTHER	Split-mouth administration for group A	* Plaque disclosing agent application and instructions to patients for a correct oral hygiene; * Airflow deplaquing with EMS handpiece (quadrants Q2 and Q4) and with Mectron handpiece (quadrants Q1 and Q3) * Calculus removal with EMS ultrasound handpiece (Q2 and Q4) and with Mectron handpiece (Q1 and Q3)

Timeline

• Start date: 2022-03-22
• Primary completion: 2022-08-29
• Completion: 2022-09-02
• First posted: 2022-03-02
• Last updated: 2024-02-20

Locations

1 site across 1 country: Italy