Dental and Occlusal StabilityPhase 3retainerNCT01583933
Essix Retainer vs Hawley Retainer
A Phase 3 study testing Essix retainer and Hawley retainer in people with Dental and Occlusal Stability, run by CES University at 1 site in Colombia.
Trial summary
There are several factors involved in the decision and the retention plan, such as occlusion, patient age, etiology of malocclusion, the speed of the correction, the length of the cusps and health of the tissues involved, relationships inclined planes, size of the arches, harmony of the arches, muscle pressure… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Dental and Occlusal Stability
- What is being tested?
- Essix retainer and Hawley retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteColombia
- Study dates
- Sep 2011to May 2012
- Phase
- Phase 3
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who have stabilized their growth between 16 and 40 who have completed orthodontic treatment and initiate retention treatment
- Who have agreed to participate in the study if elected and to sign informed consent
- Residing in the metropolitan area of Medellin and have the opportunity to attend recall appointments
Who cannot join
- Periodontal status deteriorated
- missing teeth
- Cleft lip and palate
- History of orthognathic surgery
- History of dental or skeletal open bite
- Presence of some habit oral tongue thrusting, mouth breathing, thumb sucking even after termination of orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
CES University
Medellín, Antioquia
Angela Segura, asegura@ces.edu.co
About this study
Official title: PHASE 3 STUDY OF THE EFFECTIVITY OF TWO RETAINERS IN THE DENTAL AND OCCLUSAL STABILITY
There are several factors involved in the decision and the retention plan, such as occlusion, patient age, etiology of malocclusion, the speed of the correction, the length of the cusps and health of the tissues involved, relationships inclined planes, size of the arches, harmony of the arches, muscle pressure, interdental proximal contact, cell metabolism and atmospheric pressure. Given these concepts, we need to find grounds to enable decision making with respect to the retainer that offers the best features of containment and stability.
Read the detailed description
This study aims to assess the stability of tooth position and occlusal retention during treatment with two types of retainers, Essix type retainer and the retainer plate type Hawley in individuals who have completed their growth ending orthodontic treatment at the Faculty of Dentistry University of Antioquia and CES University Medellín
- Conditions
- Dental and Occlusal Stability
- Being tested
- Essix retainer, Hawley retainer
- Keywords
- Dental stability, Occlusal stability, Retainers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essix retainerDevice
The essix retainer is made in a thermoforming copolyester 0.75mm (0.30 ", it processed gives a thickness of 0.015" approximately. Retainer will be used molar to molar. subjects in this arm will have this retainer for 24 hours a day for 6 months, they won´t have this device for food intake.
Hawley retainerDevice
subjects in this arm will have the retainer for 24 hours a day for 6 months. During food intake they won´t have this device.
| Study group | Role | What they receive |
|---|---|---|
| Essix retainer | Experimental | Not described Receives: Device: Essix retainer |
| Hawley retainer | Active comparator | Hawley retainer is a device composed of an acrylic base with built-in hooks and a labial arch wire 0.022 "x0.036" and attached to the teeth. Its metal component consists of two adams hooks positioned from the first permanent molar right to left, a labial bow that progresses from lingual superface to distal of canine to integrate with the acrylic base. Receives: Device: Hawley retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental stability
Dental stability will be assessed like this, models: rotation of central and lateral incisor, canine, first and second premolar, first molar on each side and each arch; and cephalometric analysis: SN-upper central incisive, FK-upper central incisive, palate plane-upper central incisive, interincisal angle, mandibular plane-lower central incisive; vertical distances: palate plane-upper central incisive, palate plane-first upper molar, mandibular plane-lower central incisive, mandibular plane-first lower molar; horizontal distances: A-Pogonion upper and lower central incisive.
Measured: Up to 6 months
Secondary outcomes (1)
Occlusal stability
Occlusal stability will be measured at the beginning and end of study through clinic exam and study models.
Clinic exam: canine relations right and left, molar relations left and right, overjet, overbite, presence of anterior open bite, presence of posterior open bite.
Models: upper and lower arch, upper and lower intercanine distance, upper and lower distance interpremolar, upper and lower intermolar distance.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental and Occlusal StabilityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Antioquia
- Responsible party
- Principal investigator, Angela Maria Segura Cardona, CES University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583933
- Sponsor's protocol ID
- SFHA-02
- Acronym
- retainer
- Status last verified
- Apr 2012
- First submitted
- 23 Apr 2012
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE 3 STUDY OF THE EFFECTIVITY OF TWO RETAINERS IN THE DENTAL AND OCCLUSAL STABILITY
- ClinicalTrials.gov ID
- NCT01583933
- Acronym / sponsor ID
- retainer / SFHA-02
- Conditions
- Dental and Occlusal Stability
- Keywords
- Dental stability, Occlusal stability, Retainers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Collaborators
- Universidad de Antioquia
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 24 Apr 2012 (estimated)
- 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.
There are several factors involved in the decision and the retention plan, such as occlusion, patient age, etiology of malocclusion, the speed of the correction, the length of the cusps and health of the tissues involved, relationships inclined planes, size of the arches, harmony of the arches, muscle pressure, interdental proximal contact, cell metabolism and atmospheric pressure. Given these concepts, we need to find grounds to enable decision making with respect to the retainer that offers the best features of containment and stability.
Detailed description
This study aims to assess the stability of tooth position and occlusal retention during treatment with two types of retainers, Essix type retainer and the retainer plate type Hawley in individuals who have completed their growth ending orthodontic treatment at the Faculty of Dentistry University of Antioquia and CES University Medellín
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essix retainer | Experimental | Device: Essix retainer |
| Hawley retainer | Active comparator | Device: Hawley retainerHawley retainer is a device composed of an acrylic base with built-in hooks and a labial arch wire 0.022 "x0.036" and attached to the teeth. Its metal component consists of two adams hooks positioned from the first permanent molar right to left, a labial bow that progresses from lingual superface to distal of canine to integrate with the acrylic base. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients who have stabilized their growth between 16 and 40 who have completed orthodontic treatment and initiate retention treatment
- Who have agreed to participate in the study if elected and to sign informed consent
- Residing in the metropolitan area of Medellin and have the opportunity to attend recall appointments
Key exclusion criteria (6 listed)
- Periodontal status deteriorated
- missing teeth
- Cleft lip and palate
- History of orthognathic surgery
- History of dental or skeletal open bite
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 |
|---|---|---|
| Essix retainerThe essix retainer is made in a thermoforming copolyester 0.75mm (0.30 ", it processed gives a thickness of 0.015" approximately. Retainer will be used molar to molar. subjects in this arm will have this retainer for 24 hours a day for 6 months, they won´t have this device for food intake. | Device | Essix retainer |
| Hawley retainersubjects in this arm will have the retainer for 24 hours a day for 6 months. During food intake they won´t have this device. | Device | Hawley retainer |
Primary outcome
Dental stability
Time frame: Up to 6 months
Dental stability will be assessed like this, models: rotation of central and lateral incisor, canine, first and second premolar, first molar on each side and each arch; and cephalometric analysis: SN-upper central incisive, FK-upper central incisive, palate plane-upper central incisive, interincisal angle, mandibular plane-lower central incisive; vertical distances: palate plane-upper central incisive, palate plane-first upper molar, mandibular plane-lower central incisive, mandibular plane-first lower molar; horizontal distances: A-Pogonion upper and lower central incisive.
1 secondary outcome
Occlusal stability
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Essix retainer and Hawley retainer in people with Dental and Occlusal Stability, run by CES University at 1 site in Colombia.
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 3 inclusion and 6 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 27 Apr 2012. 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 Colombia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Sandra Gómez, Orthodontist (574 3127492, sandraligomez11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental stability (time frame: Up to 6 months). 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 27 Apr 2012.