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

U

University of Pavia

Status

Completed

Conditions

Orthodontic Appliance Complication

Treatments

Other: Retainers' cleansing with water
Other: Retainers' Cleansing with Geldis®
Other: Retainers' Cleansing with tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT04871763
2021-ESSIX

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 3 patient groups

Geldis® gel
Experimental group
Description:
Patients will brush their essix retainers with a toothbrush and with Geldis® gel.
Treatment:
Other: Retainers' Cleansing with Geldis®
Tablets
Active Comparator group
Description:
Patients will leave their essix retainers in a glass with water and Polident tablets.
Treatment:
Other: Retainers' Cleansing with tablets
Water
Active Comparator group
Description:
Patients will brush essix retainers with a toothbrush under running water.
Treatment:
Other: Retainers' cleansing with water

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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