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Periodontal DiseasesNCT05263622

Guided Biofilm Therapy for Periodontal Patients.

A study testing Split-mouth administration for group B and Split-mouth administration for group A in people with Periodontal Diseases, run by University of Pavia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Periodontal Diseases
What is being tested?
Split-mouth administration for group B and Split-mouth administration for group A
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
22 Mar 2022to 2 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Pavia, Lombardy, 27100

Other trials in Italy

About this study

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

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
Read more

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.

Read the 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.

Being tested
Split-mouth administration for group B, Split-mouth administration for group A
Keywords
Guided Biofilm Therapy
Medical subject headings
Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Split-mouth administration for group BOther

    • 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 AOther

    • 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)
Study groups in NCT05263622
Study groupRoleWhat they receive
Group AExperimentalHalf of patients will be included in this group according to the split-mouth design.
Receives: Other: Split-mouth administration for group A
Group BExperimentalHalf of patients will be included in this group according to the split-mouth design.
Receives: Other: Split-mouth administration for group B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Schiff Air Index - Dental sensitivity test

    Scoring criteria:

    1. the subject did not respond to air blasting;
    2. the subject responded to air blasting;
    3. the subject responded to air blasting and requested discontinuation;
    4. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.

    Measured: Baseline, after 30 and 60 days

  2. 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).

    Measured: Baseline, after 30 and 60 days

  3. 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

    Measured: Baseline, after 30 and 60 days

  4. 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.

    Measured: Baseline, after 30 and 60 days

  5. Change in CAL - Clinical Attachment Loss

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

    Measured: Baseline, after 30 and 60 days

  6. Total time of usage

    Total time of usage of the two handpieces.

    Measured: Baseline

  7. Comfort for the operator

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

    Measured: Baseline

  8. 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

    Measured: Baseline

  9. Satisfactory questionnaire for operator

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start22 Mar 2022
  3. Primary completion29 Aug 2022
  4. Study completion2 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Split-mouth design
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05263622
Sponsor's protocol ID
2022-GBT
Status last verified
Feb 2024
First submitted
20 Feb 2022
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40223867

Questions about this trial

What is this clinical trial studying?

A study testing Split-mouth administration for group B and Split-mouth administration for group A in people with Periodontal Diseases, run by University of Pavia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Schiff Air Index - Dental sensitivity test (time frame: Baseline, after 30 and 60 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05263622, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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