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Completed

NCT Number: NCT05263622

Guided Biofilm Therapy for Periodontal Patients.

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. Change in Schiff Air Index - Dental sensitivity test

    Time frame: Baseline, after 30 and 60 days

    Scoring criteria:

    • the subject did not respond to air blasting;
    • the subject responded to air blasting;
    • the subject responded to air blasting and requested discontinuation;
    • the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.

  2. 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).

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

    Time frame: Baseline, after 30 and 60 days

    Scoring criteria:

    0: no bleeding

    • isolated visible spots
    • blood forms a confluent red line on the mucosal margin
    • profuse and copious bleeding

  4. 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.

  5. 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).

  6. Total time of usage

    Time frame: Baseline

    Total time of usage of the two handpieces.

  7. Comfort for the operator

    Time frame: Baseline

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

  8. 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

  9. Satisfactory questionnaire for operator

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

Guided Biofilm Therapy for Periodontal Patients Using Two Different Devices: a Split-mouth Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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