Temporomandibular Joint Disorders After Using Essix RetainerNCT04149366
Clinical and Radiographic Evaluation of Different Thickness of Vacuum Formed Retainer (Essix Retainer) During Retention Phase After Orthodontic Treatment
An observational study of Temporomandibular Joint Disorders After Using Essix Retainer, run by Minia University.
Trial summary
vacuum formed retainer act as bite raiser that increase vertical dimension which may affect Tempromandibular joint and aim of this study is to perform clinical and radiographic evaluation of different thickness of vacuum formed retainer (Essix retainer) during retention phase after orthodontic treatment Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Temporomandibular Joint Disorders After Using Essix Retainer
- What is being tested?
- Retainer
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2019to 25 Oct 2020
- Phase
- Observational
- 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 15 to 35 years
- All sexes
- Child, Adult
Study population: patients that have finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders
Who may be able to join
- patients finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders
- patients indicated for removable retainer
Who cannot join
- any systemic disease
- chronic medication uptake
- bad oral hygiene pathological conditions of temporomandibular joint
About this study
vacuum formed retainer act as bite raiser that increase vertical dimension which may affect Tempromandibular joint and aim of this study is to perform clinical and radiographic evaluation of different thickness of vacuum formed retainer (Essix retainer) during retention phase after orthodontic treatment
- Being tested
- Retainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetainerDevice
Orthodontic retainer
| Study group | Role | What they receive |
|---|---|---|
| group 1 (Wrapround retainer) | Not described Receives: Device: Retainer | |
| Group 2 (Essix retainer 1mm) | Not described | |
| Group 3 (Essix retainer 1.5 mm) | Not described | |
| Group 3 (Essix retainer 2mm) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effect of retainer on temporomandibular joint
Absence of pain, deviation and trismus
Measured: 9 months
Radiographic effect of retainer on tempromandibular joint
Normal dissc position
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start29 Oct 2019 (estimated)
- Primary completion25 Aug 2020 (estimated)
- Study completion25 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Disorders After Using Essix RetainerStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ahmed, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149366
- Sponsor's protocol ID
- 295
- Status last verified
- Oct 2019
- First submitted
- 27 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Different Thickness of Vacuum Formed Retainer (Essix Retainer) During Retention Phase After Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT04149366
- Acronym / sponsor ID
- 295
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 29 Oct 2019 (estimated)
- Primary completion
- 25 Aug 2020 (estimated)
- Study completion
- 25 Oct 2020 (estimated)
- First posted
- 4 Nov 2019 (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.
vacuum formed retainer act as bite raiser that increase vertical dimension which may affect Tempromandibular joint and aim of this study is to perform clinical and radiographic evaluation of different thickness of vacuum formed retainer (Essix retainer) during retention phase after orthodontic treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 (Wrapround retainer) | – | Device: Retainer |
| Group 2 (Essix retainer 1mm) | – | – |
| Group 3 (Essix retainer 1.5 mm) | – | – |
| Group 3 (Essix retainer 2mm) | – | – |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- patients that have finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders
Key inclusion criteria (2 listed)
- patients finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders
- patients indicated for removable retainer
Key exclusion criteria (3 listed)
- any systemic disease
- chronic medication uptake
- bad oral hygiene pathological conditions of temporomandibular joint
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 |
|---|---|---|
| RetainerOrthodontic retainer | Device | group 1 (Wrapround retainer) |
Primary outcome
Clinical effect of retainer on temporomandibular joint
Time frame: 9 months
Absence of pain, deviation and trismus
Radiographic effect of retainer on tempromandibular joint
Time frame: 9 months
Normal dissc position
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders After Using Essix Retainer, run by Minia University.
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 3 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: status not confirmed, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Clinical effect of retainer on temporomandibular joint (time frame: 9 months). The study lists 2 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 4 Nov 2019.