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

Not Applicable

• Conditions: Class II Division 1 Malocclusion
• Interventions: Device: skeletally anchored distal jet

• Registration Number: NCT05171738
• Lead Sponsor: Al-Azhar University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-12-19
• Study First Posted: 2021-12-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-25
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group(1)	skeletally anchored distal jet	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
group(2)	skeletally anchored distal jet	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.

Primary Outcome Measures

Name	Time	Method
change in molar postion	from start of treatment until study completion, an average of 1 year	using cephalometric x_ray for measurment

Trial Locations

Locations (1)

Al azhar university; 🇪🇬 Cairo, Egypt