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

NCT ID: NCT06936306

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-17
• Study Completion Date: 2022-10-01

Brief 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.

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

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.

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.

Conditions

Dental Plaque; Gum Bleed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Test

GBT Protocol

Group Type: EXPERIMENTAL

GBT

Intervention Type: PROCEDURE

GBT Protocol

Master

Intervention Type: DEVICE

Use master piezon

Control

Scalling and polishing

Group Type: ACTIVE_COMPARATOR

scalling

Intervention Type: PROCEDURE

scalling

Interventions

GBT

GBT Protocol

Intervention Type: PROCEDURE

Master

Use master piezon

Intervention Type: DEVICE

scalling

scalling

Intervention Type: PROCEDURE

Other Intervention Names

GBT Protocol

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

E.M.S. Electro Medical Systems S.A.

UNKNOWN

Sponsor Role: collaborator

University of Lisbon

OTHER

Sponsor Role: lead

Responsible Party

João Nascimento

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Lisbon

Lisbon, , Portugal

Countries

Portugal

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CE-FMDUL 202155

Identifier Type: -

Identifier Source: org_study_id