Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639204
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Cephalometric Changes Following Retraction of the Upper Anterior Teeth Stimulated by Low-intensity Electrical Current
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Skeletal Dental and Soft-tissue Changes After En-masse Retraction of the Upper Anterior Teeth Stimulated by Low-intensity Electrical Current A Single-centered Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Thirty-six patients requiring extraction of maxillary first premolars and en-masse retraction of upper anterior teeth will participate in the study They will be randomly assigned into two groups low-intensity electrical stimulation group LIES and traditional retraction group TRAD after the leveling and alignment phase is completed En-masse retraction will be initiated in both groups via closed nickel-titanium coil springs that applying 250 g of force on each side Mini-implants will be inserted to provide the highest level of anchorage The skeletal dental and soft tissue changes will be detected using lateral cephalometric radiographs which will be obtained pretreatment pre- and post-en-masse retraction of the anterior teeth
Detailed Description:
All candidate patients will be examined to determine the orthodontic treatment plan Written informed consent will be obtained from all patients who accept to participate in the trial Self-drilling mini-screws 16mm diameter and 8mm length will be used to provide anchorage They will be inserted bilaterally 8-10 mm above the level of the interdental papilla between the second premolars and the first molar Then the maxillary first premolar will be extracted Leveling and alignment of the upper dental arch will be done using a pre-adjusted orthodontic appliance MBT 0022 0028-inch slots-size brackets The removable electrical stimulation device utilized in the Shaadouh et al study to provide the electrical stimulation will be used in this trial for the same purpose Each patient in the low-intensity electrical stimulation group will be asked to wear a removable device for five hours daily until the completion of the retraction of the upper anterior teeth
The en-masse retraction will be done by applying 250 g force on each side using two NiTi springs attached between the mini-implants and the crimpable hooks in a direction approximately parallel to the occlusal plane The force will be calibrated every two weeks The en-masse retraction will continue until a class I canine relationship and a correct incisor relationship which will consider the endpoint of this phase
Lateral cephalometric radiographs will be obtained pretreatment pre- and post-en-masse retraction of the anterior teeth to assess the skeletal dental and soft tissue changes The duration of retraction will be calculated by calculating the time required to achieve complete retraction of the upper anterior teeth through clinical examination
The en-masse retraction will be done by applying 250 g force on each side using two NiTi springs attached between the mini-implants and the crimpable hooks in a direction approximately parallel to the occlusal plane The force will be calibrated every two weeks The en-masse retraction will continue until a class I canine relationship and a correct incisor relationship which will consider the endpoint of this phase
Lateral cephalometric radiographs will be obtained pretreatment pre- and post-en-masse retraction of the anterior teeth to assess the skeletal dental and soft tissue changes The duration of retraction will be calculated by calculating the time required to achieve complete retraction of the upper anterior teeth through clinical examination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None