Orthodontic Appliance ComplicationNCT04871763
Assessment of Bacterial Loads of Essix Retainers in Patients Under Retention Therapy
A study testing Retainers' Cleansing with Geldis®, Retainers' Cleansing with tablets and Retainers' cleansing with water in people with Orthodontic Appliance Complication, run by University of Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Retainers' Cleansing with Geldis®, Retainers' Cleansing with tablets and Retainers' cleansing with water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2021to 18 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who completed orthodontic treatment and under Essix retainers phase.
Who cannot join
- Patients under orthodontic treatment with fixed appliances or clear aligners.
- Non-orthodontic patients.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Retainers' Cleansing with Geldis®, Retainers' Cleansing with tablets, Retainers' cleansing with water
- Keywords
- oral microbiota, essix retainer, periodontal assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retainers' Cleansing with Geldis®Other
Patients will clean their essix retainers with Geldis® using a toothbrush every night for 2 months.
Retainers' Cleansing with tabletsOther
Patients will leave their essix retainers in a glass with water and Polident tablets every night for 2 months.
Retainers' cleansing with waterOther
Patients will brush their essix retainers with a toothbrush under water every night for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Geldis® gel | Experimental | Patients will brush their essix retainers with a toothbrush and with Geldis® gel. Receives: Other: Retainers' Cleansing with Geldis® |
| Tablets | Active comparator | Patients will leave their essix retainers in a glass with water and Polident tablets. Receives: Other: Retainers' Cleansing with tablets |
| Water | Active comparator | Patients will brush essix retainers with a toothbrush under running water. Receives: Other: Retainers' cleansing with water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Study begin, 1 and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start12 May 2021
- Primary completion15 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD., Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871763
- Sponsor's protocol ID
- 2021-ESSIX
- Status last verified
- Dec 2021
- First submitted
- 27 Apr 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol for the Assessment of the Bacterial Loads of Essix Retainers in Patients Under Retention Therapy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04871763
- Acronym / sponsor ID
- 2021-ESSIX
- Conditions
- Orthodontic Appliance Complication
- Keywords
- oral microbiota, essix retainer, periodontal assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Geldis® gel | Experimental | Other: Retainers' Cleansing with Geldis®Patients will brush their essix retainers with a toothbrush and with Geldis® gel. |
| Tablets | Active comparator | Other: Retainers' Cleansing with tabletsPatients will leave their essix retainers in a glass with water and Polident tablets. |
| Water | Active comparator | Other: Retainers' cleansing with waterPatients will brush essix retainers with a toothbrush under running water. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who completed orthodontic treatment and under Essix retainers phase.
Key exclusion criteria (2 listed)
- Patients under orthodontic treatment with fixed appliances or clear aligners.
- Non-orthodontic patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retainers' Cleansing with Geldis®Patients will clean their essix retainers with Geldis® using a toothbrush every night for 2 months. | Other | Geldis® gel |
| Retainers' Cleansing with tabletsPatients will leave their essix retainers in a glass with water and Polident tablets every night for 2 months. | Other | Tablets |
| Retainers' cleansing with waterPatients will brush their essix retainers with a toothbrush under water every night for 2 months. | Other | Water |
Primary outcome
Change in PCR% - Plaque Control Record (percentage)
Time frame: 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 BOP - Bleeding on Probing (percentage)
Time frame: 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 in Schiff Air Index - Dental sensitivity test
Time frame: 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 of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
Time frame: 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 microbiological loads of clear aligners
Time frame: Study begin, 1 and 2 months
Microbiological assessment of the following loads: * Porphyromonas gingivalis * Tannarella forsythensis * Treponema denticola * Peptostreptococcus micros * Total bacterial load
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD. principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retainers' Cleansing with Geldis®, Retainers' Cleansing with tablets and Retainers' cleansing with water in people with Orthodontic Appliance Complication, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PCR% - Plaque Control Record (percentage) (time frame: Study begin, 1 and 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.