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Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage

Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06507319
Enrollment
20
Registered
2024-07-18
Start date
2023-06-08
Completion date
2024-10-31
Last updated
2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary First Molar Distalization

Keywords

orthodontics, miniscrews, distalization, direct anchorage, indirect anchorage

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.

Interventions

DEVICEDirect bone anchored pull distal slider

distalization from the palatal side only.

DEVICEIndirect bone anchored dual force distalizer.

distalization from the palatal and buccal sides.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Anteroposterior skeletal measurements8 monthsFrom the lateral cephalometric, the maxillary and mandibular sagittal positions will be measured according to the SN plane, before and after distalization.
Vertical skeletal measurements8 monthsFrom the lateral cephalometric, mandibular plane angle according to the SN plane and Frankfort horizontal plane, will be measured before and after distalization.
Dental angular measurements8 monthsFrom 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 distalization8 monthsFrom 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.
Amount of intrusion8monthsFrom 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 expansion8 monthsFrom 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.
Amount of rotation8 monthsFrom 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.

Countries

Egypt

Contacts

Primary ContactZeyad M Ali, BDS
zeyadqaddomy@yahoo.com00201030172652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026