Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05302076
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2022-03-20
Brief Title:
Clinical Effects of Electrical Stimulation on Speeding up Orthodontic Tooth Movement
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Evaluation the Effect of Low-intensity Electrical Current LIEC in Accelerating the En-masse Retraction of the Maxillary Anterior Teeth and the Associated Skeletal Dental and Periodontal Changes A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Thirty two patients requiring extraction of maxillary first premolars and en-masse retraction of upper anterior teeth will participate in the study They will be divided randomly into two groups electrical group and control group In each group en-masse retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 250 g of force per side Mini-implants will be used as an anchor unit
The overall retraction duration will be calculated The skeletal dental and soft tissue changes will be detected using panoramic and lateral cephalometric radiographs which will be obtained pretreatment pre and post en-masse retraction of the anterior teeth
The overall retraction duration will be calculated The skeletal dental and soft tissue changes will be detected using panoramic and lateral cephalometric radiographs which will be obtained pretreatment pre and post en-masse retraction of the anterior teeth
Detailed Description:
Prior to enrollment of each subject into the study they will be examined completely to determine the orthodontic treatment plan The operator will inform them about the aim of the study and ask them to provide a written informed consent
Self-drilling titanium mini-implants 16mm diameter and 8mm length will be used They will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm above the archwires at the mucogingival junction and will be checked for primary stability mechanical retention Then the maxillary first premolar will be extracted The maxillary arch will be levelled and aligned The rectangular stainless steel archwires 0019 0025 with anterior 8mm height soldered hooks distal to the canines will be inserted
A removable device containing a small electrical circuit will be applied to each patient to supply the required electric current
Each patient in the electrical group will be asked to wear a removable device containing a small electrical circuit that will supply the required electric current for five hours a day until the completion the retraction of the upper anterior teeth
250-300 g force will be applied on each side using two NiTi springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction The force level will be measured every 2 weeks Retraction will be stopped when a class I canine relationship will be achieved and a good incisor relationship will be obtained
The duration of retraction will be calculated by calculating the time required to achieve complete retraction of the upper anterior teeth through clinical examination
Panoramic and 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
Periodontal health will be assessed at the beginning of orthodontic treatment before and after en-masse retraction by evaluating the following parameters plaque index gingival index bleeding index probing depth and gingival recession
Self-drilling titanium mini-implants 16mm diameter and 8mm length will be used They will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm above the archwires at the mucogingival junction and will be checked for primary stability mechanical retention Then the maxillary first premolar will be extracted The maxillary arch will be levelled and aligned The rectangular stainless steel archwires 0019 0025 with anterior 8mm height soldered hooks distal to the canines will be inserted
A removable device containing a small electrical circuit will be applied to each patient to supply the required electric current
Each patient in the electrical group will be asked to wear a removable device containing a small electrical circuit that will supply the required electric current for five hours a day until the completion the retraction of the upper anterior teeth
250-300 g force will be applied on each side using two NiTi springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction The force level will be measured every 2 weeks Retraction will be stopped when a class I canine relationship will be achieved and a good incisor relationship will be obtained
The duration of retraction will be calculated by calculating the time required to achieve complete retraction of the upper anterior teeth through clinical examination
Panoramic and 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
Periodontal health will be assessed at the beginning of orthodontic treatment before and after en-masse retraction by evaluating the following parameters plaque index gingival index bleeding index probing depth and gingival recession
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None