Guided Biofilm Therapy for Periodontal Patients.

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05263622
• Other study ID #: 2022-GBT
• Status: Completed
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: September 2, 2022

Study information

• Verified date: February 2024
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2, 2022
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

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)
• 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)

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Total time of usage	Total time of usage of the two handpieces.	Baseline
Primary	Comfort for the operator	Evaluation of the comfort of the operator from 0 to 10 during professional procedures.	Baseline
Primary	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
Primary	Satisfactory questionnaire for operator	Comfort (from 0 to 10) Timing (from 0 to 10)	Baseline