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| Sponsored by: |
Shaheed Beheshti Medical University |
|---|---|
| Information provided by: | Shaheed Beheshti Medical University |
| ClinicalTrials.gov Identifier: | NCT00688233 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Orthodontic Appliance Design Retrognathism Malocclusion, Angle Class II Deepbite |
Device: Seifi's Functional |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy 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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| F-seifi: Experimental |
Device: Seifi's Functional
Patient with Class II Division 1 and Deepbite malocclusion will wear the Seifi's Functional to get the benefit of skeletal and dentoalveolar correction.
|
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.
Eligibility| Ages Eligible for Study: | 8 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Massoud Seifi, DDS,MSD | 98-21-2204-3343 | seifimassoud@gmail.com |
| Iran, Islamic Republic of | |
| Dental School, Shahid Beheshti Medical Sciences University | Recruiting |
| Tehran, Iran, Islamic Republic of | |
| Contact: Nafiseh Memar Kermani, DDS 98-21-2240-3010 | |
| Principal Investigator: Massoud Seifi, DDS, MSD | |
| Principal Investigator: Majid Bargrizan, DDS, MSD | |
| Principal Investigator: Nafiseh Memar Kermani, DDS | |
| Study Chair: | Massoud Seifi, DDS, MSD | Shahid Beheshti Medical Sciences University |
More Information
| Responsible Party: | Shahid Beheshti Medical University ( Professor Massoud Seifi ) |
| Study ID Numbers: | 234567 |
| Study First Received: | May 23, 2008 |
| Last Updated: | May 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00688233 |
| Health Authority: | Iran: Ministry of Health |
|
Seifi's Functional, Class II/1, Mandibular Retrognathism |
|
Tooth Diseases Malocclusion Musculoskeletal Diseases Craniofacial Abnormalities Bites and Stings Maxillofacial Abnormalities |
Stomatognathic Diseases Congenital Abnormalities Malocclusion, Angle Class II Retrognathism Musculoskeletal Abnormalities |
|
Mandibular Diseases Jaw Diseases Stomatognathic System Abnormalities Jaw Abnormalities |
