Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars
- Conditions
- Class II Malocclusion
- Interventions
- Device: Intra-Oral Distalizing Device
- Registration Number
- NCT05592977
- Lead Sponsor
- Future University in Egypt
- Brief Summary
There is a scarcity in the current literature regarding such appliance and its effect on distalizing the first maxillary molar in absence of the second molar. Therefore, this study was made to evaluate the effect of bilateral distalization of upper first molars in a group of patients after extraction of maxillary second Molars using infra zygomatic mini implants.
- Detailed Description
The appliances available for distalization used to be mainly extraoral distalizing appliances which depended entirely on patient cooperation and compliance. Even after the emergence of intra-oral distalizing appliances they had adverse dentoalveolar effect such as anchorage loss and flaring of the upper anterior teeth. Thus, this study was made in order to evaluate the efficiency of our proposed appliance in the treatment of Class II patients while avoiding the adverse effects mentioned above.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
- Female Patients with cervical vertebra maturation index (CVMI) 5 & 6.
- From quarter unit to 3\4-unit class II molar relationship.
- An overjet of an average 6mm.
- Full Set of permanent dentition except for the maxillary second molar.
- Favorable path of eruption for the maxillary third molar.
- Medically compromised Patients.
- Patients under long term medications.
- Patients having sever periodontal disease.
- CVMI 3 or less
- Full unit class II cases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intra-oral Distalizing Appliance Intra-Oral Distalizing Device Two infra zygomatic mini-implants will be placed Bands will be cemented to upper first molars. The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. Orthodontic force 300 mg per side Will be delivered by Niti closed coil spring which is attached from infra zygomatic mini screw to the hook soldered to the wire framework.
- Primary Outcome Measures
Name Time Method linear distalization of maxillary 1st molar. Up until Class I Molar Relation (a maximum of 8 months regardless) Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts as well as cone-beam computed tomography (CBCT) in millimetres.
Rate of maxillary 1st molar Distalization in mm/ month. Up until Class I Molar Relation (a maximum of 8 months regardless) Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts with a monthly follow up in millimetres.
- Secondary Outcome Measures
Name Time Method Changes in Intermolar width in mm. Up until Class I Molar Relation (a maximum of 8 months regardless) Effect of the proposed appliance on the transverse Dental changes in the upper buccal segment through scanned dental cast in millimetres
Changes of Molar inclination in degrees. Up until Class I Molar Relation (a maximum of 8 months regardless) Effect of the proposed appliance on the angulation of the first permanent molar through scanned dental cast and cone-beam computed tomography (CBCT) in degrees.
Trial Locations
- Locations (1)
Future University In Egypt
🇪🇬New Cairo, Cairo, Egypt