Distalization Via Skeletally-anchored Distaljet Appliance With Two Approaches of Micro-osteoperforations

NCT05171738 | Unknown

• 1 other identifier: 788/309
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

study will be directed to evaluate two approaches of micro-osteoperforations during maxillary molar distalization.

Conditions

Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (1)

• change in molar postion

  using cephalometric x\_ray for measurment

  from start of treatment until study completion, an average of 1 year

Study Arms (2)

group(1)

ACTIVE COMPARATOR

Group I: will include ten patients undergo maxillary molar distalization using skeletally anchored distal jet appliance with MOPs that will be performed buccally on repeated basis on two sides before and during maxillary molar distalization

Device: skeletally anchored distal jet

group(2)

ACTIVE COMPARATOR

Group II:will include ten patients undergo maxillary molar distalization using skeletally anchored distal jet appliance with MOPs that will be performed both buccally and palatally on repeated basis on two sides before and during maxillary molar distalization.

Device: skeletally anchored distal jet

Interventions

skeletally anchored distal jet DEVICE

used from day one and activated every month

group(1); group(2)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients should satisfy the following criteria:-
• Age range from 13-17 years.
• Bilateral Class II molar relationship.
• Skeletal Class I or mild Class II relationship.
• Normodivergent skeletal pattern
• No posterior crowding or diastemas.
• Fully erupted maxillary first and second molars.
• Congenitally missing or extracted third molars.
• Good oral and general health.
• No systemic disease/medication that could interfere with OTM.
• No previous orthodontic treatment.

You may not qualify if:

• Patient diagnosed to have an indication for non-extraction approach.
• Poor oral hygiene or periodontally compromised patient.
• Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
• Previous orthodontic treatment

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al azhar university

Cairo, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

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: BDS (2017), Faculty of Dental Medicine (Cairo-Boys) Al-Azhar University

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 29, 2021
• Study Start: September 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

EG (1)