Orthodontic Appliance Complication Clinical Trial
Official title:
A Protocol for the Assessment of the Bacterial Loads of Essix Retainers in Patients Under Retention Therapy: a Randomized Clinical Trial
Verified date | December 2021 |
Source | University of Pavia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | December 18, 2021 |
Est. primary completion date | December 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Patients who completed orthodontic treatment and under Essix retainers phase. Exclusion Criteria: - Patients under orthodontic treatment with fixed appliances or clear aligners. - Non-orthodontic patients. |
Country | Name | City | State |
---|---|---|---|
Italy | Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy |
Lead Sponsor | Collaborator |
---|---|
University of Pavia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Change in Schiff Air Index - Dental sensitivity test | Scoring criteria: 0: the subject did not respond to air blasting; 1: the subject responded to air blasting; 2: the subject responded to air blasting and requested discontinuation; 3: the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful. |
Study begin, 1 and 2 months | |
Primary | Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008) | Scoring criteria: 0: no erosive tooth wear; initial loss of surface texture; distinct defect, hard tissue loss < 50% of the surface area; hard tissue loss = 50% of the surface area. |
Study begin, 1 and 2 months | |
Primary | Change in microbiological loads of clear aligners | Microbiological assessment of the following loads: Porphyromonas gingivalis Tannarella forsythensis Treponema denticola Peptostreptococcus micros Total bacterial load |
Study begin, 1 and 2 months |
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