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

NCT06936306 | Completed

• 1 other identifier: CE-FMDUL 202155
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque; Gum Bleed

Keywords

Guided Biofilm Therapy; Dental plaque; Oral Hygiene; Air Polishing; Confort; Biofilm disclosing

Outcome Measures

Primary Outcomes (1)

• GBI

  Ainamo \& Bay gingival bleeding index

  4 weeks

Secondary Outcomes (2)

• PCR

  4 weeks

• PI

  4 weeks

Study Arms (2)

Test

EXPERIMENTAL

GBT Protocol

Procedure: GBT; Device: Master

Control

ACTIVE COMPARATOR

Scalling and polishing

Procedure: scalling

Interventions

GBT PROCEDURE

GBT Protocol

Also known as: GBT Protocol

Test

Master DEVICE

Use master piezon

Test

scalling PROCEDURE

scalling

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lisbon: lead
• E.M.S. Electro Medical Systems S.A.: collaborator

Study Sites (1)

University Lisbon

Lisbon, Portugal

Location

MeSH Terms

Conditions

Dental Plaque; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Mouth Diseases; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: April 20, 2025
• Study Start: March 17, 2022
• Primary Completion: April 29, 2022
• Study Completion: October 1, 2022
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)