Guided Biofilm Therapy for Periodontal Patients Using Two Different Devices: a Split-mouth Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Periodontal Diseases
- Sponsor
- University of Pavia
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in BOP - Bleeding on Probing (percentage)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in BOP - Bleeding on Probing (percentage)
Time Frame: Baseline, after 30 and 60 days
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 Schiff Air Index - Dental sensitivity test
Time Frame: Baseline, after 30 and 60 days
Scoring criteria: 0. the subject did not respond to air blasting; 1. the subject responded to air blasting; 2. the subject responded to air blasting and requested discontinuation; 3. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
Change in Bleeding Score (BS - Mombelli et al.)
Time Frame: Baseline, after 30 and 60 days
Scoring criteria: 0: no bleeding 1. isolated visible spots 2. blood forms a confluent red line on the mucosal margin 3. profuse and copious bleeding
Change in CAL - Clinical Attachment Loss
Time Frame: Baseline, after 30 and 60 days
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Total time of usage
Time Frame: Baseline
Total time of usage of the two handpieces.
Satisfactory questionnaire for operator
Time Frame: Baseline
Comfort (from 0 to 10) Timing (from 0 to 10)
Comfort for the operator
Time Frame: Baseline
Evaluation of the comfort of the operator from 0 to 10 during professional procedures.
Satisfactory questionnaire for patients
Time Frame: Baseline
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
Change in Probing Pocket Depth (PPD)
Time Frame: Baseline, after 30 and 60 days
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.