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

NCT ID: NCT04871763

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2021-12-18

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.

Conditions

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Orthodontic Appliance Complication

Keywords

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oral microbiota essix retainer periodontal assessment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Geldis® gel

Patients will brush their essix retainers with a toothbrush and with Geldis® gel.

Group Type EXPERIMENTAL

Retainers' Cleansing with Geldis®

Intervention Type OTHER

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

Tablets

Patients will leave their essix retainers in a glass with water and Polident tablets.

Group Type ACTIVE_COMPARATOR

Retainers' Cleansing with tablets

Intervention Type OTHER

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

Water

Patients will brush essix retainers with a toothbrush under running water.

Group Type ACTIVE_COMPARATOR

Retainers' cleansing with water

Intervention Type OTHER

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

Interventions

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Retainers' Cleansing with Geldis®

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

Intervention Type OTHER

Retainers' Cleansing with tablets

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

Intervention Type OTHER

Retainers' cleansing with water

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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Research Resident, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2021-ESSIX

Identifier Type: -

Identifier Source: org_study_id