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

Appraisal of Two Different Approaches of Micro-osteoperforations During Maxillary Molar Distalization Via Skeletally-anchored Distaljet Appliance

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

Study Overview

• Status: Active, not recruiting
• Conditions: Class II Division 1 Malocclusion
• Intervention / Treatment: Device: skeletally anchored distal jet

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; used from day one and activated every month
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; used from day one and activated every month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in molar postion	using cephalometric x_ray for measurment	from start of treatment until study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 19, 2021
• First Posted (ACTUAL): December 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 788/309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No