Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage
- Conditions
- Maxillary First Molar Distalization
- Interventions
- Device: Indirect bone anchored dual force distalizer.Device: Direct bone anchored pull distal slider
- Registration Number
- NCT06507319
- Lead Sponsor
- Mansoura University
- Brief Summary
Aim of study: this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.
Material and methods: The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University.
Patients will be divided into 2 groups, group 1 will be treated by direct bone anchored pull distal slider, and group 2 by indirect bone anchored dual force distalizer.
- Detailed Description
Aim of study:
this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.
Participant and eligibility criteria:
The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University. pretreatment records will be taken including: intraoral and extraoral photographs, study models, panoramic radiographs, and lateral cephalometric radiographs.
Intervention:
written and informed consents will be taken from the patients.
Group 1:
* Two metal bands will be chosen and fitted on the maxillary first molars.
* Rubber base impression material will be taken with bands in place.
* Two metal bands will be placed in their relative positions in the impression and then poured up with stone.
* Send it to the LAB for appliance fabrication.
* At delivery day, the appliance will be cemented on the maxillary first molars by glass ionomer luting cement and two miniscrews will be placed in their positions.
* The appliance will be activated by closed coil spring, which apply 300g force. Patients will be monitored every 3 weeks.
Group 2:
* Four metal bands ( two for maxillary first premolars and two for maxillary first molars ) will be chosen and fitted on the teeth.
* Rubber base impression material will be taken with bands in place.
* Four metal bands will be placed in their relative positions in the impression and then poured up with stone.
* Send it to the LAB for appliance fabrication.
* At delivery day, the appliance will be cemented on the teeth by glass ionomer luting cement and two miniscrews will be placed in their positions, and activated by compressing the NiTi open coil spring, which apply 300g force. Patients will be monitored every 3 weeks.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Dental class II.
- No or mild to moderate maxillary teeth crowding.
- Erupted or partially erupted maxillary second molars.
- No previous orthodontic therapy.
- Absence or minimum crowding in the mandibular arch.
- Good oral hygiene.
- Dental class I, III
- severe maxillary teeth crowding.
- Extracted or badly decayed maxillary first molars.
- Previous orthodontic therapy.
- Severe crowding in the mandibular arch.
- Bad oral hygiene.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Indirect bone anchored dual force distalizer. Indirect bone anchored dual force distalizer. The appliance will be cemented on the teeth and two miniscrews will be placed in their positions. Activated by compressing the NiTi open coil spring from the buccal and palatal sides. Direct bone anchored pull distal slider Direct bone anchored pull distal slider The appliance will be cemented on the maxillary first molars and two miniscrews will be placed in their positions. The appliance will be activated by closed coil spring, which apply 300g force.
- Primary Outcome Measures
Name Time Method Anteroposterior skeletal measurements 8 months From the lateral cephalometric, the maxillary and mandibular sagittal positions will be measured according to the SN plane, before and after distalization.
Amount of distalization 8 months From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the pterygoid vertical (PTV) plane will be measured before and after distalization to calculate the amount of distalization in mm.
Vertical skeletal measurements 8 months From the lateral cephalometric, mandibular plane angle according to the SN plane and Frankfort horizontal plane, will be measured before and after distalization.
Dental angular measurements 8 months From the lateral cephalometric, the angle between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the SN plane will be measured before and after distalization to measure the amount of tipping.
Amount of rotation 8 months From the study model, the angle between buccopalatal axis of teeth (maxillary first premolar, second premolar, first molar) and the midpalatal suture will be measured before and after distalization to calculate the amount of rotation.
Amount of intrusion 8months From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the palatal plane (PP) will be measured before and after distalization to calculate the amount of intrusion in mm.
.Amount of expansion 8 months From the study model, the maxillary inter-canine, inter-first premolar, inter-second premolar, inter-first molar, and inter-second molar widths will be measured before and after distalization to calculate the amount of expansion in mm.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Faculty of Dentistry
🇪🇬Mansoura, Egypt