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Guided Biofilm Therapy for Periodontal Patients.

Primary Purpose

Periodontal Diseases

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Split-mouth administration for group B

Split-mouth administration for group A

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Guided Biofilm Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Group B

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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).

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

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.

Change in CAL - Clinical Attachment Loss

Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).

Total time of usage

Total time of usage of the two handpieces.

Comfort for the operator

Evaluation of the comfort of the operator from 0 to 10 during professional procedures.

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

Satisfactory questionnaire for operator

Comfort (from 0 to 10) Timing (from 0 to 10)

Secondary Outcome Measures

Full Information

NCT ID

NCT05263622

First Posted

February 20, 2022

Last Updated

September 7, 2022

Sponsor

University of Pavia

1. Study Identification

Unique Protocol Identification Number

NCT05263622

Brief Title

Guided Biofilm Therapy for Periodontal Patients.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 22, 2022 (Actual)

Primary Completion Date

August 29, 2022 (Actual)

Study Completion Date

September 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases

Keywords

Guided Biofilm Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Split-mouth design

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Split-mouth administration for group B

Intervention Description

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

Intervention Name(s)

Split-mouth administration for group A

Intervention Description

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)

Primary Outcome Measure Information:

Title

Change in Schiff Air Index - Dental sensitivity test

Description

Time Frame