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

NCT04871763 | Completed

• 1 other identifier: 2021-ESSIX
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Appliance Complication

Keywords

oral microbiota; essix retainer; periodontal assessment

Outcome Measures

Primary Outcomes (5)

• 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; 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.

  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

Study Arms (3)

Geldis® gel

EXPERIMENTAL

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

Other: Retainers' Cleansing with Geldis®

Tablets

ACTIVE COMPARATOR

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

Other: Retainers' Cleansing with tablets

Water

ACTIVE COMPARATOR

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

Other: Retainers' cleansing with water

Interventions

Retainers' Cleansing with Geldis® OTHER

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

Geldis® gel

Retainers' Cleansing with tablets OTHER

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

Tablets

Retainers' cleansing with water OTHER

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

Water

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who completed orthodontic treatment and under Essix retainers phase.

You may not qualify if:

• Patients under orthodontic treatment with fixed appliances or clear aligners.
• Non-orthodontic patients.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Interventions

Tablets; Water

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Andrea Scribante, DDS, PhD.

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 4, 2021
• Study Start: May 12, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 18, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)