Orthodontic Retention ComplianceOrthoComplyNCT03683862
Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers
A study testing orthodontic appliance in people with Orthodontic Retention Compliance, run by University of Athens at 1 site in Greece.
Trial summary
This study aims to assess adolescent's compliance after the end of orthodontic treatment using either thermoplastic or Hawley retainers in the upper arch, with the aid of TheraMon microsensor (MC Technology GmbH). Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Retention Compliance
- What is being tested?
- orthodontic appliance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteGreece
- Study dates
- 3 Jan 2018to 5 Mar 2019
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients that have completed orthodontic treatment (are at stage of debonding) with fixed appliances in the upper and lower arch
- age 12- 18
Who cannot join
- systematic diseases
- craniofacial anomalies (clefts, etc)
- handicapped patients with problems of compliance
- pregnant women
- previous orthodontic treatment or compromise orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Greece1 site
School of Dentistry, Department of Orthodontics, National and Kapodistrian University of Athens
Athens, 11527 Goudi
About this study
Official title: Objective Evaluation of Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers: A Randomized Controlled Trial
This study aims to assess adolescent's compliance after the end of orthodontic treatment using either thermoplastic or Hawley retainers in the upper arch, with the aid of TheraMon microsensor (MC Technology GmbH).
- Conditions
- Orthodontic Retention Compliance
- Being tested
- orthodontic appliance
- Keywords
- hawley, thermoplastic, orthodontic retention, compliance, vacuum- formed
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthodontic applianceOther
Orthodontic device for retention in the upper arch, after the end of orthodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| Thermoplastic Retainer | Experimental | Impressions of the upper arch will be taken at the day of bracket debonding and the retainer will be delivered in 24 hours. TheraMon microchip will be embedded within the appliance and patients will be instructed to wear the appliance 24 hours/ day. Receives: Other: orthodontic appliance |
| Hawley Retainer | Active comparator | Impressions of the upper arch will be taken at the day of bracket debonding and the retainer will be delivered in 24 hours. TheraMon microchip will be embedded within the appliance and patients will be instructed to wear the appliance 24 hours/ day. Receives: Other: orthodontic appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of retainer wear
Compliance of retainer wear at 3 months, as expressed by average hours of daily wear (with the aid of TheraMon)
Measured: 3 months
Secondary outcomes (3)
Compliance of retainer wear
Compliance of retainer wear at 1 month, as expressed by average hours of daily wear (with the aid of TheraMon)
Measured: 1 month
Association between objective compliance assessment and diary reported hours
Association between objective compliance assessment (TheraMon) and diary reported hours (by patient)
Measured: 3 months
Association between objective compliance assessment and diary reported hours
Association between objective compliance assessment (TheraMon) and diary reported hours (by patient)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start3 Jan 2018
- Primary completion5 Mar 2019
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Retention ComplianceStudies 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Despina Koletsi, University of Athens
- Investigators
- Georgia Vagdouti, Principal investigator, School of Dentistry, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683862
- Sponsor's protocol ID
- 341/10.07.17
- Acronym
- OrthoComply
- Status last verified
- Mar 2019
- First submitted
- 23 Sep 2018
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Vagdouti G, Karvouni E, Bitsanis E, Koletsi D. Objective evaluation of compliance after orthodontic treatment using Hawley or vacuum-formed retainers: A 2-center randomized controlled trial over a 3-month period. Am J Orthod Dentofacial Orthop. 2019 Dec;156(6):717-726.e2. doi: 10.1016/j.ajodo.2019.07.008.
PubMed 31784005
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Evaluation of Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03683862
- Acronym / sponsor ID
- OrthoComply / 341/10.07.17
- Conditions
- Orthodontic Retention Compliance
- Keywords
- hawley, thermoplastic, orthodontic retention, compliance, vacuum- formed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 25 Sep 2018 (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.
This study aims to assess adolescent's compliance after the end of orthodontic treatment using either thermoplastic or Hawley retainers in the upper arch, with the aid of TheraMon microsensor (MC Technology GmbH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermoplastic Retainer | Experimental | Other: orthodontic applianceImpressions of the upper arch will be taken at the day of bracket debonding and the retainer will be delivered in 24 hours. TheraMon microchip will be embedded within the appliance and patients will be instructed to wear the appliance 24 hours/ day. |
| Hawley Retainer | Active comparator | Other: orthodontic applianceImpressions of the upper arch will be taken at the day of bracket debonding and the retainer will be delivered in 24 hours. TheraMon microchip will be embedded within the appliance and patients will be instructed to wear the appliance 24 hours/ day. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients that have completed orthodontic treatment (are at stage of debonding) with fixed appliances in the upper and lower arch
- age 12- 18
Key exclusion criteria (5 listed)
- systematic diseases
- craniofacial anomalies (clefts, etc)
- handicapped patients with problems of compliance
- pregnant women
- previous orthodontic treatment or compromise orthodontic treatment
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 |
|---|---|---|
| orthodontic applianceOrthodontic device for retention in the upper arch, after the end of orthodontic treatment | Other | Hawley Retainer, Thermoplastic Retainer |
Primary outcome
Compliance of retainer wear
Time frame: 3 months
Compliance of retainer wear at 3 months, as expressed by average hours of daily wear (with the aid of TheraMon)
3 secondary outcomes
Compliance of retainer wear
Time frame: 1 month
Association between objective compliance assessment and diary reported hours
Time frame: 3 months
Association between objective compliance assessment and diary reported hours
Time frame: 1 month
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 28 Mar 2019.
- Derived from this study: PubMed 31784005Vagdouti G, Karvouni E, Bitsanis E, Koletsi D. Objective evaluation of compliance after orthodontic treatment using Hawley or vacuum-formed retainers: A 2-center randomized controlled trial over a 3-month period. Am J Orthod Dentofacial Orthop. 2019 Dec;156(6):717-726.e2. doi: 10.1016/j.ajodo.2019.07.008.
- Individual participant dataSharing planned: Yes
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.
Georgia Vagdouti principal investigator
School of Dentistry, National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthodontic appliance in people with Orthodontic Retention Compliance, run by University of Athens at 1 site in Greece.
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 2 inclusion and 5 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 28 Mar 2019. 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 Greece. 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?
Compliance of retainer wear (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683862, which also lists 1 linked publication.
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 28 Mar 2019.