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

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.

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Other: Retainers' Cleansing with Geldis®; Other: Retainers' Cleansing with tablets; Other: Retainers' cleansing with water

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 18, 2021

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: May 1, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 18, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: oral microbiota; essix retainer; periodontal assessment
• Other Study ID Numbers: 2021-ESSIX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be available upon motivated request to Principal Investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No