Guided Biofilm Therapy for Periodontal Patients.

University of Pavia

Status: Completed

Conditions: Periodontal Diseases

Treatments: Other: Split-mouth administration for group A; Other: Split-mouth administration for group B

Study type: Interventional

Funder types: Other

Identifiers

NCT05263622

2022-GBT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Other: Split-mouth administration for group A

Group B

Experimental group

Description:

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

Treatment:

Other: Split-mouth administration for group B