Clinical trial NCT05263622: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Guided Biofilm Therapy
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Schiff Air Index - Dental sensitivity test
timeFrame: Baseline, after 30 and 60 days
measure: Change in BOP - Bleeding on Probing (percentage)
timeFrame: Baseline, after 30 and 60 days
measure: Change in Bleeding Score (BS - Mombelli et al.)
timeFrame: Baseline, after 30 and 60 days
measure: Change in Probing Pocket Depth (PPD)
timeFrame: Baseline, after 30 and 60 days
measure: Change in CAL - Clinical Attachment Loss
timeFrame: Baseline, after 30 and 60 days
measure: Total time of usage
timeFrame: Baseline
measure: Comfort for the operator
timeFrame: Baseline
measure: Satisfactory questionnaire for patients
timeFrame: Baseline
measure: Satisfactory questionnaire for operator
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: