Guided Biofilm Therapy for Periodontal Patients.

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Other: Split-mouth administration for group A; Other: Split-mouth administration for group B

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Half of patients will be included in this group according to the split-mouth design.	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)
Experimental: Group B; Half of patients will be included in this group according to the split-mouth design.	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, MS, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): August 29, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Guided Biofilm Therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 2022-GBT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No