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

Mansoura University

Status: Enrolling

Conditions: Maxillary First Molar Distalization

Treatments: Device: Direct bone anchored pull distal slider; Device: Indirect bone anchored dual force distalizer.

Study type: Interventional

Funder types: Other

Identifiers

NCT06507319

Doctor Zeyad Mahmoud Ali

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 12 to 16 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Direct bone anchored pull distal slider

Experimental group

Description:

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.

Treatment:

Device: Direct bone anchored pull distal slider

Indirect bone anchored dual force distalizer.

Experimental group

Description:

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.

Treatment:

Device: Indirect bone anchored dual force distalizer.