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Completed

NCT Number: NCT04871763

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

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.

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Key information

Conditions

Orthodontic Appliance Complication

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retainers' Cleansing with Geldis®

Other

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

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.

Primary outcomes

  1. Change in PCR% - Plaque Control Record (percentage)

    Time frame: 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.

  2. Change in BOP - Bleeding on Probing (percentage)

    Time frame: Study begin, 1 and 2 months

    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%.

  3. Change in Schiff Air Index - Dental sensitivity test

    Time frame: Study begin, 1 and 2 months

    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.

  4. Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)

    Time frame: Study begin, 1 and 2 months

    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.

  5. Change in microbiological loads of clear aligners

    Time frame: Study begin, 1 and 2 months

    Microbiological assessment of the following loads:

    • Porphyromonas gingivalis
    • Tannarella forsythensis
    • Treponema denticola
    • Peptostreptococcus micros
    • Total bacterial load

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 4, 2021
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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