Guided Biofilm Therapy for Periodontal Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-22

Study Completion Date

2022-09-02

Brief Summary

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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.

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Detailed Description

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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

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split-mouth design

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A

Half of patients will be included in this group according to the split-mouth design.

Group Type EXPERIMENTAL

Split-mouth administration for group A

Intervention Type OTHER

* 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)

Group B

Half of patients will be included in this group according to the split-mouth design.

Group Type EXPERIMENTAL

Split-mouth administration for group B

Intervention Type OTHER

* 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)

Interventions

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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)

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* professional dental hygiene performed at least 6 months before enrollment
* periodontal disease: grading A or B and staging I-III

Exclusion Criteria

* neurologic, psychiatric and mental diseases
* patients taking antibiotics during the study
* pregnant and breastfeeding women
* patients undergoing anticancer treatment
* patients undergoing anticancer therapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No