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

NCT06507319 | Recruiting

• 1 other identifier: Doctor Zeyad Mahmoud Ali
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary First Molar Distalization

Keywords

orthodontics; miniscrews; distalization; direct anchorage; indirect anchorage

Outcome Measures

Primary Outcomes (7)

• Anteroposterior skeletal measurements

  From the lateral cephalometric, the maxillary and mandibular sagittal positions will be measured according to the SN plane, before and after distalization.

  8 months

• Vertical skeletal measurements

  From the lateral cephalometric, mandibular plane angle according to the SN plane and Frankfort horizontal plane, will be measured before and after distalization.

  8 months

• Dental angular measurements

  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.

  8 months

• Amount of distalization

  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.

  8 months

• Amount of intrusion

  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. .

  8months

• Amount of expansion

  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.

  8 months

• Amount of rotation

  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.

  8 months

Study Arms (2)

Direct bone anchored pull distal slider

EXPERIMENTAL

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.

Device: Direct bone anchored pull distal slider

Indirect bone anchored dual force distalizer.

EXPERIMENTAL

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.

Device: Indirect bone anchored dual force distalizer.

Interventions

Direct bone anchored pull distal slider DEVICE

distalization from the palatal side only.

Direct bone anchored pull distal slider

Indirect bone anchored dual force distalizer. DEVICE

distalization from the palatal and buccal sides.

Indirect bone anchored dual force distalizer.

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Egypt

RECRUITING

Central Study Contacts

Zeyad M Ali, BDS

CONTACT

00201030172652; zeyadqaddomy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist Zeyad Mahmoud

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 18, 2024
• Study Start: June 8, 2023
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)