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Dental PlaqueNCT06936306

Effect of Professional Prophylaxis on Clinical Parameters and Patient Comfort: Randomized Slipt-Mouth Clinical Trial

A study testing GBT, Master and scalling in people with Dental Plaque and Gum Bleed, run by University of Lisbon at 1 site in Portugal.

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

The goal of this clinical trial is to evaluate whether the Guided Biofilm Therapy (GBT) protocol can improve or maintain oral health and whether it provides more comfort to patients compared to a conventional protocol. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dental Plaque, Gum Bleed
What is being tested?
GBT, Master and scalling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 sitePortugal
Study dates
17 Mar 2022to 1 Oct 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • healthy, unmedicated, without periodontitis, and with more than 20 natural teeth

Who cannot join

  • dental implants, with periodontal pockets equal to or greater than 4, with fixed orthodontic appliances, with special needs, with some medical pathology, taking antibiotics 3 months before the study, smokers, with known hypersensitivity to erythritol and patients who did not complete the follow-up.

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • University Lisbon

    Lisbon

Other trials in Portugal

About this study

The goal of this clinical trial is to evaluate whether the Guided Biofilm Therapy (GBT) protocol can improve or maintain oral health and whether it provides more comfort to patients compared to a conventional protocol.

The study involved 25 adult patients aged 18 years or older, healthy, unmedicated, with more than 20 natural teeth, and no periodontitis.

Read more

Main Questions it Aims to Answer:

  • Does the GBT protocol improve or maintain oral health compared to a conventional protocol?
  • Is the GBT protocol more comfortable for patients than the conventional protocol? Comparison Group: Researchers compared the conventional protocol (used in quadrants I and III for Group A, and in quadrants II and IV for Group B) to the test GBT protocol (used in the opposite quadrants) to see if the GBT protocol results in improved clinical outcomes and better patient comfort.

Participants Will:

  • Undergo two different protocols for oral prophylaxis (GBT and conventional protocols) on separate quadrants of their mouth.
  • Have their clinical parameters assessed at three time points: baseline (T0), one week (T1), and three weeks (T2) after the intervention.
  • Rate the comfort of the intervention using a Visual Analog Scale (VAS) on a Likert scale from 0 to 10 for each quadrant.
Read the detailed description

After the initial evaluation of the participants and their inclusion in the study, the participants were randomized in blocks into group A where a conventional protocol was used in quadrants I and III and the test protocol in quadrants II and IV, and group B where a conventional protocol was used in quadrants II and IV and the test protocol in quadrants I and III.

The observations were made at three different times: baseline, one week after the intervention, and three weeks after the intervention. (Figure 1) The clinical assessment of each participant was performed using the the Ainamo \& Bay gingival bleeding index (GBI), the O'Leary plaque control record (PCR) and the Silness and Löe plaque index (PI). (26-28) The primary outcome variable of the study was the Gingival Bleeding Index (GBI) with the Plaque Index (PI) as a secondary outcome variable.

Hard and soft deposits were removed according to the protocol assigned in one appointment performed by the principal investigator the day after the first data collection. The control protocol consisted of mechanical scaling with Woodpecker® scaler (Guilin, Guangxi, 541004 P.R.China) at power 1, followed by stain removal and polishing with R\&S RUBBER DOME (R\&S® Dental products 25, Rue Bleue - 75009 Paris) with Prophy Paste CCS® polishing paste RDA 250 (Directa AB P.O. Box 723, SE-194 27 Upplands Väsby, Sweden) at a speed of 10,000 rotations per minute.

The test protocol consisted in an assessment of the periodontal status following the application of the plaque discloser (Biofilm Discloser, Dr. Wittmann GmbH \& Co KG 64673 Zwingenberg - Germany), followed by oral hygiene instructions and biofilm removal with an erythritol jet (Airflow Plus Powder®, Electro Medical Systems S.A.), Chemin de la Vuarpillière, 31, 1260 Nyon - Switzerland) with the Airflow Prophylaxis Master® device (Electro Medical Systems S.A., Chemin de la Vuarpillière, 31, 1260 Nyon - Switzerland). The jet stream was used at a power of 3 and the irrigation at a power of 10. Calculus removal was then performed with the piezon scaller of the same device using a PS scaler tip (Electro Medical Systems® S.A., Chemin de la Vuarpillière, 31, 1260 Nyon - Switzerland).

The first follow-up assessment (T1) was performed one week after the intervention, and the second follow-up assessment (T2) was performed 3 weeks after the intervention performed by the same research assistant that performed the initial assessment (T0). indecesThe precision and accuracy of the data collection was ensured by calibrating the instruments used and the investigators to minimize and control possible measurement errors. The assistant investigator underwent calibration before the start of the study to train the indeces, followed by a discussion of the criteria with the principal investigator.

After the appointment the participant rated comfort using a Visual Analog Scale measured on a Likert scale of 0 to 10 for each quadrant.

Being tested
GBT, Master, scalling
Keywords
Guided Biofilm Therapy, Dental plaque, Oral Hygiene, Air Polishing, Confort, Biofilm disclosing
Medical subject headings
Dental Plaque, Gingival Hemorrhage

What participants receive

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

  • GBTProcedure or surgery

    Also called GBT Protocol

    GBT Protocol

  • MasterDevice

    Use master piezon

  • scallingProcedure or surgery

    scalling

Study groups in NCT06936306
Study groupRoleWhat they receive
TestExperimentalGBT Protocol
Receives: Procedure: GBT; Device: Master
ControlActive comparatorScalling and polishing
Receives: Procedure: scalling

What is being measured

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

  1. GBI

    Ainamo \& Bay gingival bleeding index

    Measured: 4 weeks

Secondary outcomes (2)
  1. PCR

    O'Leary plaque control record

    Measured: 4 weeks

  2. PI

    Silness and Löe plaque index

    Measured: 4 weeks

Timeline

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

  1. First posted20 Apr 2025
  2. Study start17 Mar 2022
  3. Primary completion29 Apr 2022
  4. Study completion1 Oct 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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06936306
Sponsor's protocol ID
CE-FMDUL 202155
Status last verified
Apr 2025
First submitted
30 Nov 2024
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing GBT, Master and scalling in people with Dental Plaque and Gum Bleed, run by University of Lisbon at 1 site in Portugal.

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 1 inclusion and 1 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 24 Apr 2025. 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 Portugal. 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?

GBI (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 24 Apr 2025.

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