NCT05428189

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

Efficacy of the Disclosing Plaque Agent as a Guide to Remove the Oral Biofilm in Orthodontic Patients: a Randomised Controlled Trial Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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).

Detailed description

Oral biofilm is not always visible, so its complete removal can be challenging. Applying a plaque disclosing agent before the therapy might serve as a guide to better remove biofilm. Thanks to this tool, the clinicians can clearly see where the plaque is, so its removal can be more thorough. In orthodontic patients, it is even more difficult to remove biofilm and plaque, as the fixed appliances pose an obstacle. The hypothesis is that using a plaque disclosing agent as a guide to the operator, better removal of the biofilm can be achieved. The study will be performed to assess the efficacy of disclosing plaque agent as a guide to remove biofilm and plaque in orthodontic patients during professional oral hygiene, performed with air-polishing with erythritol powder and a ultrasonic device. TRIAL DESIGN: Monocetric, pragmatic, single blinded, randomized clinical trial (RCT) of parallel design.The trial will have one-year duration. STUDY POPULATION: Orthodontic patients with plaque index above the 25% and without periodontal disease. PRIMARY OUTCOME: the percentage of area in which the disclosing plaque agent is present after the treatment (RPA: Residual Plaque Area). RPA: residual plaque area: percentage of area with residual plaque coloured by plaque disclosing agent. This will be analysed and calculated with a image analysis software (ImageJ).

Conditions

• Plaque

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Plaque Disclosing Agent	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.
DEVICE	Airpolishing and ultrasonic debridement	Air-polishing will be used as main instrument for biofilm and stains removal, followed by ultrasonic scaling.

Timeline

• Start date: 2020-10-10
• Primary completion: 2022-05-25
• Completion: 2022-05-25
• First posted: 2022-06-22
• Last updated: 2022-06-22

Locations

1 site across 1 country: Italy