Guided Biofilm Therapy for Periodontal Patients.

Study Overview
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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.

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.

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

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Other: Split-mouth administration for group B
* Other: Split-mouth administration for group A


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split-mouth design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Half of patients will be included in this group according to the split-mouth design. | Other: Split-mouth administration for group A<br>* 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)<br>|
| Experimental: Group B<br>Half of patients will be included in this group according to the split-mouth design. | Other: Split-mouth administration for group B<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Schiff Air Index - Dental sensitivity test | Scoring criteria: 0. the subject did not respond to air blasting; the subject responded to air blasting; the subject responded to air blasting and requested discontinuation; the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful. | Baseline, after 30 and 60 days | 
| Change in BOP - Bleeding on Probing (percentage) | Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 4 sites (mesial, distal, vestibular, palatal/lingual). | Baseline, after 30 and 60 days | 
| Change in Bleeding Score (BS - Mombelli et al.) | Scoring criteria: 0: no bleeding isolated visible spots blood forms a confluent red line on the mucosal margin profuse and copious bleeding | Baseline, after 30 and 60 days | 
| Change in Probing Pocket Depth (PPD) | Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites. | Baseline, after 30 and 60 days | 
| Change in CAL - Clinical Attachment Loss | Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ). | Baseline, after 30 and 60 days | 
| Total time of usage | Total time of usage of the two handpieces. | Baseline | 
| Comfort for the operator | Evaluation of the comfort of the operator from 0 to 10 during professional procedures. | Baseline | 
| Satisfactory questionnaire for patients | Choice of a score from 0 to 10 for all the following questions: Is the time for the procedures appropriate? Is the quantity of droplets adequate? Dental sensitivity Pain with the first instrument Pain with the second instrument General pain | Baseline | 
| Satisfactory questionnaire for operator | Comfort (from 0 to 10) Timing (from 0 to 10) | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guided Biofilm Therapy