Status:
COMPLETED
Efficacy of the Disclosing Plaque Agent as a Guide to Remove the Oral Biofilm in Orthodontic Patients.
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions:
Plaque
Eligibility:
All Genders
18-75 years
Phase:
NA
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 pl...
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 to...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05428189
Start Date
October 10 2020
End Date
May 25 2022
Last Update
June 22 2022
Active Locations (1)
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1
Magda
Brescia, Lombardy, Italy, 25123