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Status unknownNCT05171738Updated Apr 25, 2022

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

An interventional study of skeletally anchored distal jet in Class II Division 1 Malocclusion, sponsored by Al-Azhar University. Status unknown at 1 site in Egypt. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-04-25.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
All
01

Study summary

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

Read the detailed description

Maxillary molar distalization via skeletally anchored distal jet appliance randomly divided into two equal groups

02

Conditions studied

  • Class II Division 1 Malocclusion

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03

In context

Malocclusion

457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.

This study's planned enrollment of 20 is below the median of 36 across 372 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Inclusion criteria:

All patients should satisfy the following criteria:-

  1. Age range from 13-17 years.
  2. Bilateral Class II molar relationship.
  3. Skeletal Class I or mild Class II relationship.
  4. Normodivergent skeletal pattern
  5. No posterior crowding or diastemas.
  6. Fully erupted maxillary first and second molars.
  7. Congenitally missing or extracted third molars.
  8. Good oral and general health.
  9. No systemic disease/medication that could interfere with OTM.
  10. No previous orthodontic treatment.

Exclusion Criteria:

  • Exclusion criteria:

    1. Patient diagnosed to have an indication for non-extraction approach.
    2. Poor oral hygiene or periodontally compromised patient.
    3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
    4. Previous orthodontic treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    group(1)

    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

  • Active comparator
    group(2)

    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

  • Deviceskeletally anchored distal jet

    used from day one and activated every month

06

What researchers measure

Primary outcomes

  1. change in molar postion

    using cephalometric x_ray for measurment

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

07

Study locations

1 site
  • Al azhar university
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05171738
Lead sponsor
Al-Azhar University
Responsible party
khaled abd el khaliq hendy (BDS (2017), Faculty of Dental Medicine (Cairo-Boys) Al-Azhar University, Al-Azhar University) — Principal investigator
First posted
Dec 29, 2021
Start date
Sep 1, 2021
Primary completion
Oct 1, 2023 (estimated)
Completion
Nov 1, 2023 (estimated)
Last update
Apr 25, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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