Assessment of Bacterial Loads of Essix Retainers in Patients Under Retention Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Protocol for the Assessment of the Bacterial Loads of Essix Retainers in Patients Under Retention Therapy: a Randomized Clinical Trial

Conditions
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Orthodontic Appliance Complication

Intervention / Treatment
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* Other: Retainers' Cleansing with Geldis®
* Other: Retainers' Cleansing with tablets
* Other: Retainers' cleansing with water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Geldis® gel<br>Patients will brush their essix retainers with a toothbrush and with Geldis® gel. | Other: Retainers' Cleansing with Geldis®<br>* Patients will clean their essix retainers with Geldis® using a toothbrush every night for 2 months.<br>|
| Active Comparator: Tablets<br>Patients will leave their essix retainers in a glass with water and Polident tablets. | Other: Retainers' Cleansing with tablets<br>* Patients will leave their essix retainers in a glass with water and Polident tablets every night for 2 months.<br>|
| Active Comparator: Water<br>Patients will brush essix retainers with a toothbrush under running water. | Other: Retainers' cleansing with water<br>* Patients will brush their essix retainers with a toothbrush under water every night for 2 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral microbiota, essix retainer, periodontal assessment