Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars Using Infra Zygomatic Mini Implants: A Prospective Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Future University in Egypt
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- linear distalization of maxillary 1st molar.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Due to the nature of the study, the operator and patients can't be blinded. Blinding of the outcome assessors can be done by sealing the name of the patient in the pre and post treatment radiographs used for analysis
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female Patients with cervical vertebra maturation index (CVMI) 5 &
- •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.
Exclusion Criteria
- •Medically compromised Patients.
- •Patients under long term medications.
- •Patients having sever periodontal disease.
- •CVMI 3 or less
- •Full unit class II cases
Arms & Interventions
Intra-oral Distalizing Appliance
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.
Intervention: Intra-Oral Distalizing Device (Device)
Outcomes
Primary Outcomes
linear distalization of maxillary 1st molar.
Time Frame: 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.
Time Frame: 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 Outcomes
- Changes in Intermolar width in mm.(Up until Class I Molar Relation (a maximum of 8 months regardless))
- Changes of Molar inclination in degrees.(Up until Class I Molar Relation (a maximum of 8 months regardless))
Investigators
Hosam Abdullah Mohamed Zaza
Principle investigator
Future University in Egypt