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

Not Applicable

Completed

• Conditions: Orthodontic Appliance Complication
• Interventions: Other: Retainers' Cleansing with Geldis®; Other: Retainers' cleansing with water; Other: Retainers' Cleansing with tablets

• Registration Number: NCT04871763
• Lead Sponsor: University of Pavia

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.

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-05-01
• Study First Posted: 2021-05-04
• Study Start: 2021-05-12
• Status Verified: 2021-12
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-18
• Last Update Submitted: 2021-12-18
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Geldis® gel	Retainers' Cleansing with Geldis®	Patients will brush their essix retainers with a toothbrush and with Geldis® gel.
Water	Retainers' cleansing with water	Patients will brush essix retainers with a toothbrush under running water.
Tablets	Retainers' Cleansing with tablets	Patients will leave their essix retainers in a glass with water and Polident tablets.

Primary Outcome Measures

Name	Time	Method
Change in BOP - Bleeding on Probing (percentage)	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%.
Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)	Study begin, 1 and 2 months	Scoring 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 Schiff Air Index - Dental sensitivity test	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.
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 microbiological loads of clear aligners	Study begin, 1 and 2 months	Microbiological assessment of the following loads: * Porphyromonas gingivalis; * Tannarella forsythensis; * Treponema denticola; * Peptostreptococcus micros; * Total bacterial load

Trial Locations

Locations (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy