Back to resultsEffect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars
Primary Purpose
Class II Malocclusion
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intra-Oral Distalizing Device
Sponsored by
About this trial
This is an interventional treatment trial for Class II Malocclusion focused on measuring Intermolar Width, Molar Inclination, Intra-oral Appliance, Infrazygomatic Mini-screws, Distalization
Eligibility Criteria
Inclusion Criteria:
- Female Patients with cervical vertebra maturation index (CVMI) 5 & 6.
- From quarter unit to 3\4-unit class II molar relationship.
- An overjet of an average 6mm.
- Full Set of permanent dentition except for the maxillary second molar.
- Favorable path of eruption for the maxillary third molar.
Exclusion Criteria:
- Medically compromised Patients.
- Patients under long term medications.
- Patients having sever periodontal disease.
- CVMI 3 or less
- Full unit class II cases
Sites / Locations
- Future University In Egypt
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intra-oral Distalizing Appliance
Arm Description
Two infra zygomatic mini-implants will be placed Bands will be cemented to upper first molars. The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. Orthodontic force 300 mg per side Will be delivered by Niti closed coil spring which is attached from infra zygomatic mini screw to the hook soldered to the wire framework.
Outcomes
Primary Outcome Measures
linear distalization of maxillary 1st molar.
Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts as well as cone-beam computed tomography (CBCT) in millimetres.
Rate of maxillary 1st molar Distalization in mm/ month.
Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts with a monthly follow up in millimetres.
Secondary Outcome Measures
Changes in Intermolar width in mm.
Effect of the proposed appliance on the transverse Dental changes in the upper buccal segment through scanned dental cast in millimetres
Changes of Molar inclination in degrees.
Effect of the proposed appliance on the angulation of the first permanent molar through scanned dental cast and cone-beam computed tomography (CBCT) in degrees.
Full Information
NCT ID
NCT05592977
First Posted
June 5, 2021
Last Updated
February 16, 2023
Sponsor
Future University in Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05592977
Brief Title
Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars
Official Title
Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars Using Infra Zygomatic Mini Implants: A Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future University in Egypt
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
There is a scarcity in the current literature regarding such appliance and its effect on distalizing the first maxillary molar in absence of the second molar. Therefore, this study was made to evaluate the effect of bilateral distalization of upper first molars in a group of patients after extraction of maxillary second Molars using infra zygomatic mini implants.
Detailed Description
The appliances available for distalization used to be mainly extraoral distalizing appliances which depended entirely on patient cooperation and compliance. Even after the emergence of intra-oral distalizing appliances they had adverse dentoalveolar effect such as anchorage loss and flaring of the upper anterior teeth. Thus, this study was made in order to evaluate the efficiency of our proposed appliance in the treatment of Class II patients while avoiding the adverse effects mentioned above.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion
Keywords
Intermolar Width, Molar Inclination, Intra-oral Appliance, Infrazygomatic Mini-screws, Distalization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Due to the nature of the study, the operator and patients can't be blinded. Blinding of the outcome assessors can be done by sealing the name of the patient in the pre and post treatment radiographs used for analysis
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intra-oral Distalizing Appliance
Arm Type
Experimental
Arm Description
Two infra zygomatic mini-implants will be placed Bands will be cemented to upper first molars. The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars.
Orthodontic force 300 mg per side Will be delivered by Niti closed coil spring which is attached from infra zygomatic mini screw to the hook soldered to the wire framework.
Intervention Type
Device
Intervention Name(s)
Intra-Oral Distalizing Device
Intervention Description
The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. The anterior component of the inner bow is 3 mm free from the labial surface of anterior teeth
Primary Outcome Measure Information:
Title
linear distalization of maxillary 1st molar.
Description
Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts as well as cone-beam computed tomography (CBCT) in millimetres.
Time Frame
Up until Class I Molar Relation (a maximum of 8 months regardless)
Title
Rate of maxillary 1st molar Distalization in mm/ month.
Description
Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts with a monthly follow up in millimetres.
Time Frame
Up until Class I Molar Relation (a maximum of 8 months regardless)
Secondary Outcome Measure Information:
Title
Changes in Intermolar width in mm.
Description
Effect of the proposed appliance on the transverse Dental changes in the upper buccal segment through scanned dental cast in millimetres
Time Frame
Up until Class I Molar Relation (a maximum of 8 months regardless)
Title
Changes of Molar inclination in degrees.
Description
Effect of the proposed appliance on the angulation of the first permanent molar through scanned dental cast and cone-beam computed tomography (CBCT) in degrees.
Time Frame
Up until Class I Molar Relation (a maximum of 8 months regardless)
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female Patients with cervical vertebra maturation index (CVMI) 5 & 6.
From quarter unit to 3\4-unit class II molar relationship.
An overjet of an average 6mm.
Full Set of permanent dentition except for the maxillary second molar.
Favorable path of eruption for the maxillary third molar.
Exclusion Criteria:
Medically compromised Patients.
Patients under long term medications.
Patients having sever periodontal disease.
CVMI 3 or less
Full unit class II cases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehia Mostafa, Professr and Chairman
Organizational Affiliation
Future University in Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Future University In Egypt
City
New Cairo
State/Province
Cairo
ZIP/Postal Code
11835
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected individual participant data (IPD)
IPD Sharing Time Frame
Data will be available after publication
Learn more about this trial
Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars
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