Plaque Clinical Trial
— ORTOPLAKOfficial title:
Efficacy of the Disclosing Plaque Agent as a Guide to Remove the Oral Biofilm in Orthodontic Patients: a Randomised Controlled Trial Study
NCT number | NCT05428189 |
Other study ID # | ORTOPLAK |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 10, 2020 |
Est. completion date | May 25, 2022 |
Verified date | June 2022 |
Source | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 32 |
Est. completion date | May 25, 2022 |
Est. primary completion date | May 25, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Magda | Brescia | Lombardia |
Lead Sponsor | Collaborator |
---|---|
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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