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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04871763
Enrollment
15
Registered
2021-05-04
Start date
2021-05-12
Completion date
2021-12-18
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Appliance Complication

Keywords

oral microbiota, essix retainer, periodontal assessment

Brief summary

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

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.

Interventions

OTHERRetainers' Cleansing with Geldis®

Patients will clean their essix retainers with Geldis® using a toothbrush every night for 2 months.

OTHERRetainers' Cleansing with tablets

Patients will leave their essix retainers in a glass with water and Polident tablets every night for 2 months.

OTHERRetainers' cleansing with water

Patients will brush their essix retainers with a toothbrush under water every night for 2 months.

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in PCR% - Plaque Control Record (percentage)Study begin, 1 and 2 months% 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.
Change in BOP - Bleeding on Probing (percentage)Study begin, 1 and 2 monthsSite-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%.
Change in Schiff Air Index - Dental sensitivity testStudy begin, 1 and 2 monthsScoring 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.
Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)Study begin, 1 and 2 monthsScoring criteria: 0: no erosive tooth wear; 1. initial loss of surface texture; 2. distinct defect, hard tissue loss \< 50% of the surface area; 3. hard tissue loss ≥ 50% of the surface area.
Change in microbiological loads of clear alignersStudy begin, 1 and 2 monthsMicrobiological assessment of the following loads: * Porphyromonas gingivalis * Tannarella forsythensis * Treponema denticola * Peptostreptococcus micros * Total bacterial load

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026