Orthodontic Appliance DesignPhase 1Seifi-FxNCT00688233
Effect of the Innovated Seifi's Functional Appliance on Skeletal and Dentoalveolar Changes of Class II/ 1, Deep Bite
A Phase 1 study testing Seifi's Functional in people with Orthodontic Appliance Design and Retrognathism, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
For improving the appearance of protruded upper front teeth when lower front teeth may touch palatal mucosa or have proximity to that; the innovated Seifi's Functional Appliance may be used. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Design, Retrognathism, Malocclusion, Angle Class II
- What is being tested?
- Seifi's Functional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Dec 2007to May 2009
- Phase
- Phase 1
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 8 - 12 years old
- Class Π division 1 malocclusion (ANB>4)
- Increased over jet (>4mm)
- Increased overbite (>4mm)
Who cannot join
- History of previous orthodontic treatment
- Evidence of craniofacial syndromes
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Dental School, Shahid Beheshti Medical Sciences University
Tehran, Tehran Province
Nafiseh Memar Kermani, DDS, 98-21-2240-3010
Massoud Seifi, DDS, MSD
About this study
Official title: Phase 1 Effect of the Innovated Seifi's Functional Appliance on the Skeletal and Dentoalveolar Changes of Class II/Division 1, Deep Bite Cases
For improving the appearance of protruded upper front teeth when lower front teeth may touch palatal mucosa or have proximity to that; the innovated Seifi's Functional Appliance may be used.
Read the detailed description
Records will be obtained for each patient by the same operator before treatment and at the end of treatment. The appliance in this study is designed by Prof. Seifi and will be constructed by a well trained technician in the orthodontic laboratory of shahid Beheshti School of dentistry under the supervision of the operator. The appliance consists of a jack screw in the midpalatal region plus two Adams' clasps on the upper 1st molars and four Kimia clasps on the buccal embrasure of the upper deciduous molars or premolars. For the mandibular portion there is an incisal clasp and incisors are capped by acrylic.
The participants will be advised to use the appliance 24 hours per day except for meal times and when brushing the teeth or reading Farsi or English in class room.
Each patient will pay his/her first recall visit to the orthodontic department one week after the appliance delivery and will be instructed to turn the maxillary expansion jack screw 1:4 turn twice a week to achieve coordination of the upper and lower arches in the transverse dimension. The patients will be evaluated over one month intervals and necessary adjustments were made.
All cephalometric records, before and after treatment, will be coded and analyzed by a second party and the ultimate results and evaluations will be made.
- Being tested
- Seifi's Functional
- Keywords
- Seifi's Functional, Class II/1, Mandibular Retrognathism
- Medical subject headings
- Retrognathia, Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seifi's FunctionalDevice
Also called Functional Therapy, Class II correction, Deepbite correction
Patient with Class II Division 1 and Deepbite malocclusion will wear the Seifi's Functional to get the benefit of skeletal and dentoalveolar correction.
| Study group | Role | What they receive |
|---|---|---|
| F-seifi | Experimental | Not described Receives: Device: Seifi's Functional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overjet and Overbite
Measured: 2-6 month depending on the amount of OJ and OB and the patient compliances
Secondary outcomes (1)
sagittal and vertical cephalometric measurements
Measured: before-after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2008 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance DesignStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Massoud Seifi, DDS, MSD, Study chair, Shahid Beheshti Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688233
- Sponsor's protocol ID
- 234567
- Acronym
- Seifi-Fx
- Status last verified
- May 2008
- First submitted
- 23 May 2008
- Last updated
- 2 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Effect of the Innovated Seifi's Functional Appliance on the Skeletal and Dentoalveolar Changes of Class II/Division 1, Deep Bite Cases
- ClinicalTrials.gov ID
- NCT00688233
- Acronym / sponsor ID
- Seifi-Fx / 234567
- Keywords
- Seifi's Functional, Class II/1, Mandibular Retrognathism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Oct 2008 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 2 Jun 2008 (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.
For improving the appearance of protruded upper front teeth when lower front teeth may touch palatal mucosa or have proximity to that; the innovated Seifi's Functional Appliance may be used.
Detailed description
Records will be obtained for each patient by the same operator before treatment and at the end of treatment. The appliance in this study is designed by Prof. Seifi and will be constructed by a well trained technician in the orthodontic laboratory of shahid Beheshti School of dentistry under the supervision of the operator. The appliance consists of a jack screw in the midpalatal region plus two Adams' clasps on the upper 1st molars and four Kimia clasps on the buccal embrasure of the upper deciduous molars or premolars. For the mandibular portion there is an incisal clasp and incisors are capped by acrylic.
The participants will be advised to use the appliance 24 hours per day except for meal times and when brushing the teeth or reading Farsi or English in class room.
Each patient will pay his/her first recall visit to the orthodontic department one week after the appliance delivery and will be instructed to turn the maxillary expansion jack screw 1:4 turn twice a week to achieve coordination of the upper and lower arches in the transverse dimension. The patients will be evaluated over one month intervals and necessary adjustments were made.
All cephalometric records, before and after treatment, will be coded and analyzed by a second party and the ultimate results and evaluations will be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F-seifi | Experimental | Device: Seifi's Functional |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 8 - 12 years old
- Class Π division 1 malocclusion (ANB>4)
- Increased over jet (>4mm)
- Increased overbite (>4mm)
Key exclusion criteria (2 listed)
- History of previous orthodontic treatment
- Evidence of craniofacial syndromes
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 |
|---|---|---|
| Seifi's FunctionalAlso: Functional Therapy, Class II correction, Deepbite correctionPatient with Class II Division 1 and Deepbite malocclusion will wear the Seifi's Functional to get the benefit of skeletal and dentoalveolar correction. | Device | F-seifi |
Primary outcome
Overjet and Overbite
Time frame: 2-6 month depending on the amount of OJ and OB and the patient compliances
1 secondary outcome
sagittal and vertical cephalometric measurements
Time frame: before-after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2008.
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.
Massoud Seifi, DDS, MSD study chair
Shahid Beheshti Medical Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Seifi's Functional in people with Orthodontic Appliance Design and Retrognathism, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Jun 2008. 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 Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Massoud Seifi, DDS,MSD (98-21-2204-3343, seifimassoud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overjet and Overbite (time frame: 2-6 month depending on the amount of OJ and OB and the patient compliances). 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 2 Jun 2008.