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The aim of this study is to investigate the bacterial loads present on essix retainers in patients' contention therapy. Patients are randomly divided into three groups, depending on the product used for the cleansing of the retainers: Geldis, Polident tablets and water. Microbiological samples were taken from the retainers at the baseline, after 1 and after 2 months, together with Bleeding Index, Plaque Index, BEWE Index and Schiff Air Sensitivity test.
The aim of this study is to investigate the bacterial loads present on essix retainers in patients' contention therapy. Patients who wear essix retainers for contention therapy are randomly divided into three groups, depending on the product used for the cleansing of the retainers: Geldis, Polident tablets and water. Periodontal evaluation and microbiological samples are conducted at the baseline, after 1 and after 2 months.
Bacterial loads are collected from essix retainers, whereas Bleeding Index, Plaque Index, BEWE Index and Schiff Air Sensitivity test are assessed from the patients' mouth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geldis® gel | Experimental | Patients will brush their essix retainers with a toothbrush and with Geldis® gel. |
|
| Tablets | Active Comparator | Patients will leave their essix retainers in a glass with water and Polident tablets. |
|
| Water | Active Comparator | Patients will brush essix retainers with a toothbrush under running water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retainers' Cleansing with Geldis® | Other | Patients will clean their essix retainers with Geldis® using a toothbrush every night for 2 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in PCR% - Plaque Control Record (percentage) | % assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage. | Study begin, 1 and 2 months |
| Change in BOP - Bleeding on Probing (percentage) | Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 4 sites (mesial, distal, vestibular, palatal/lingual). Percentage of sites with bleeding on probing determines the BOP%. | Study begin, 1 and 2 months |
| Change in Schiff Air Index - Dental sensitivity test | Scoring criteria:
| Study begin, 1 and 2 months |
| Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008) | Scoring criteria: 0: no erosive tooth wear;
| Study begin, 1 and 2 months |
| Change in microbiological loads of clear aligners | Microbiological assessment of the following loads:
| Study begin, 1 and 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD. | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
Data will be available upon motivated request to Principal Investigator
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| ID | Term |
|---|---|
| D013607 | Tablets |
| D014867 | Water |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D006878 | Hydroxides |
| D000468 | Alkalies |
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| Retainers' Cleansing with tablets | Other | Patients will leave their essix retainers in a glass with water and Polident tablets every night for 2 months. |
|
| Retainers' cleansing with water | Other | Patients will brush their essix retainers with a toothbrush under water every night for 2 months. |
|
| D007287 |
| Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |