Efficacy of the Disclosing Plaque Agent as a Guide to Remove the Oral Biofilm in Orthodontic Patients.

NCT05428189 | Completed DMC

• 1 other identifier: ORTOPLAK
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

It is more difficult to perform excellent professional oral hygiene in patients wearing orthodontic appliances. The hypothesis of the present randomized controlled trial is that the application of plaque disclosing agent allows better biofilm removal. To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups:

• CONTROL GROUP will receive professional oral hygiene without disclosing agent
• TEST GROUP will receive professional oral hygiene guided by plaque disclosing agent At the end of the professional oral hygiene session, the disclosing agent is re-applied in all patients and the percentage of residual plaque area is calculated though image software analysis (ImageJ).

Conditions

Plaque

Keywords

Oral Hygiene; Dental Care; Orthodontic Patient; Disclosing Plaque Agent

Outcome Measures

Primary Outcomes (1)

• Residual Plaque Area (RPA)

  The percentage of area in which plaque is still present, as revealed by re-application of plaque disclosing agent, in both groups at the end of the treatment session

  At the end of the treatment session

Study Arms (2)

Guided Biofilm Therapy (GBT)

EXPERIMENTAL

The subjects receive professional oral hygiene guided by plaque a disclosing agent, using air-polishing and a ultrasonic device

Diagnostic Test: Plaque Disclosing Agent; Device: Airpolishing and ultrasonic debridement

Air Polishing and Ultrasonic Debridment

ACTIVE COMPARATOR

The subject receive professional oral hygiene using air-polishing and a ultrasonic device

Device: Airpolishing and ultrasonic debridement

Interventions

Plaque Disclosing Agent DIAGNOSTIC_TEST

A plaque disclosing agent is applied on teeth to detect plaque. Air-polishing will be used as main instrument for biofilm and stains removal, followed by ultrasonic scaling.

Guided Biofilm Therapy (GBT)

Airpolishing and ultrasonic debridement DEVICE

Air-polishing will be used as main instrument for biofilm and stains removal, followed by ultrasonic scaling.

Air Polishing and Ultrasonic Debridment; Guided Biofilm Therapy (GBT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form;
• Male and female subjects, aged 18-75 years, inclusive;
• Presence of orthodontic appliances;
• Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives);
• Generalized gingivitis;
• Plaque index (PI) above 25%;
• Availability for session of the study for an assigned subject;
• Presence of all inferior and superior anterior teeth from canine to canine;
• Smoking less than 10 cigarettes a day.

You may not qualify if:

• Chronic obstructive pulmonary disease and asthma;
• Patients with periodontally disease defined as presence of PPD \>= 4mm and /or PAL of \>=3m;
• Splinted teeth;
• Presence of prosthesis;
• Tumors or significant pathology of the soft or hard tissues of the oral cavity;
• Current radiotherapy or chemotherapy;
• Pregnant or lactating women;
• History of allergy to Erythritol;
• History of adverse reactions to lactose or fermented milk products;
• Restorations on the teeth to be treated which may interfere with treatment administration and/or scoring procedures, at the discretion of the examiner;
• Not willing to follow the agreed protocol.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Magda

Brescia, Lombardy, 25123, Italy

Location

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Magda Mensi

  ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Monocetric, single blinded, randomized clinical trial, parallel design.

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 22, 2022
• Study Start: October 10, 2020
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)