Back to resultsDistalization Via Skeletally-anchored Distaljet Appliance With Two Approaches of Micro-osteoperforations
Primary Purpose
Class II Division 1 Malocclusion
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
skeletally anchored distal jet
Sponsored by
About this trial
This is an interventional treatment trial for Class II Division 1 Malocclusion
Eligibility Criteria
Inclusion Criteria:
- Inclusion criteria:
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.
Exclusion Criteria:
Exclusion criteria:
- 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
Sites / Locations
- Al azhar university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group(1)
group(2)
Arm Description
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 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.
Outcomes
Primary Outcome Measures
change in molar postion
using cephalometric x_ray for measurment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05171738
Brief Title
Distalization Via Skeletally-anchored Distaljet Appliance With Two Approaches of Micro-osteoperforations
Official Title
Appraisal of Two Different Approaches of Micro-osteoperforations During Maxillary Molar Distalization Via Skeletally-anchored Distaljet Appliance
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group(1)
Arm Type
Active Comparator
Arm Description
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
Arm Title
group(2)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
skeletally anchored distal jet
Intervention Description
used from day one and activated every month
Primary Outcome Measure Information:
Title
change in molar postion
Description
using cephalometric x_ray for measurment
Time Frame
from start of treatment until study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria:
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.
Exclusion Criteria:
Exclusion criteria:
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
Facility Information:
Facility Name
Al azhar university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Distalization Via Skeletally-anchored Distaljet Appliance With Two Approaches of Micro-osteoperforations
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