Guided Biofilm Therapy for Periodontal Patients.

NCT05263622 | Completed

• 1 other identifier: 2022-GBT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

Guided Biofilm Therapy

Outcome Measures

Primary Outcomes (9)

• Change in Schiff Air Index - Dental sensitivity test

  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.

  Baseline, after 30 and 60 days

• 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).

  Baseline, after 30 and 60 days

• Change in Bleeding Score (BS - Mombelli et al.)

  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

  Baseline, after 30 and 60 days

• 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.

  Baseline, after 30 and 60 days

• Change in CAL - Clinical Attachment Loss

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

  Baseline, after 30 and 60 days

• Total time of usage

  Total time of usage of the two handpieces.

  Baseline

• Comfort for the operator

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

  Baseline

• 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

  Baseline

• Satisfactory questionnaire for operator

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

  Baseline

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: Split-mouth administration for group A

Group B

EXPERIMENTAL

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

Other: Split-mouth administration for group B

Interventions

Split-mouth administration for group B OTHER

* 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)

Group B

Split-mouth administration for group A OTHER

* 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)

Group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• professional dental hygiene performed at least 6 months before enrollment
• periodontal disease: grading A or B and staging I-III

You may not qualify if:

• neurologic, psychiatric and mental diseases
• patients taking antibiotics during the study
• pregnant and breastfeeding women
• patients undergoing anticancer treatment
• patients undergoing anticancer therapy

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

Related Publications (1)

• Chiesa A, Pascadopoli M, Butera A, Monticone M, Mirando M, Vezzoni F, Kertalli A, Scribante A, Nardi GM. Differences Between Two Devices With Function of Periopolishing and Piezoelectric Scaler: A Randomized Clinical Trial. Int J Dent. 2025 Mar 4;2025:7131637. doi: 10.1155/ijod/7131637. eCollection 2025.

  PMID: 40223867 DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD, MS

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Model Details: Split-mouth design

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 2, 2022
• Study Start: March 22, 2022
• Primary Completion: August 29, 2022
• Study Completion: September 2, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

IT (1)