Guided Biofilm Therapy for Periodontal Patients.

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Other: Split-mouth administration for group B; Other: Split-mouth administration for group A

• Registration Number: NCT05263622
• Lead Sponsor: University of Pavia

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.

Study Timeline

• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-02
• Study Start: 2022-03-22
• Primary Completion: 2022-08-29
• Study Completion: 2022-09-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Split-mouth administration for group B	Half of patients will be included in this group according to the split-mouth design.
Group A	Split-mouth administration for group A	Half of patients will be included in this group according to the split-mouth design.

Primary Outcome Measures

Name	Time	Method
Change in BOP - Bleeding on Probing (percentage)	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	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.)	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	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	Baseline	Total time of usage of the two handpieces.
Satisfactory questionnaire for operator	Baseline	Comfort (from 0 to 10) Timing (from 0 to 10)
Comfort for the operator	Baseline	Evaluation of the comfort of the operator from 0 to 10 during professional procedures.
Satisfactory questionnaire for patients	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)	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.

Trial Locations

Locations (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy