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

Orthodontic Appliance Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871763
• Other study ID #: 2021-ESSIX
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: December 18, 2021

Study information

• Verified date: December 2021
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 18, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthodontic Appliance Complication

Intervention

Other:
• Retainers' Cleansing with Geldis®
Patients will clean their essix retainers with Geldis® using a toothbrush every night for 2 months.
• Retainers' Cleansing with tablets
Patients will leave their essix retainers in a glass with water and Polident tablets every night for 2 months.
• Retainers' cleansing with water
Patients will brush their essix retainers with a toothbrush under water every night for 2 months.

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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