Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05350280
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2022-04-22
Brief Title:
Evaluation of the Effect of Electrical Stimulation on the Rate of Orthodontic Tooth Movement and the Dental Arches
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Evaluation the Effects of Low-intensity Electrical Current on the Rate of Orthodontic Tooth Movement and Dentoalveolar Changes During En-masse Retraction of Maxillary Anterior Teeth A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-04
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-eight patients requiring extraction of maxillary first premolars and maximum anchorage to retract the 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 dental changes will be detected using dental casts and to evaluate the rate of teeth retraction
The dental changes will be detected using dental casts and to evaluate the rate of teeth retraction
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 8-10mm 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 the device for five hours a day until the completion of the retraction of the upper anterior
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
Dental casts will be used for the quantification of the anteroposterior movement of the anterior teeth and the first molars every 30 days until class I canine relationship will be achieved and a good incisor relationship will be obtained Photographs of the upper casts will be taken with a central vertical projection on the occlusal plane and with a millimeter scale at the same level used to standardize and calibrate the conditions to match the casts when photographing them Reference points will be used for upper casts study and the measurements will be calculated using the Image J computer program To evaluate the movement of the anterior teeth we will project the incisive edge on the median line and measure the distance from this point to the projected position of the medial end of the third palatine wrinkle on the median line
To evaluate the movement of the first molars we will project the mesial contact point of the first molar on the median line and measure the distance from this point to the to the projected position of the medial end of the third palatine wrinkle on the median line
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 8-10mm 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 the device for five hours a day until the completion of the retraction of the upper anterior
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
Dental casts will be used for the quantification of the anteroposterior movement of the anterior teeth and the first molars every 30 days until class I canine relationship will be achieved and a good incisor relationship will be obtained Photographs of the upper casts will be taken with a central vertical projection on the occlusal plane and with a millimeter scale at the same level used to standardize and calibrate the conditions to match the casts when photographing them Reference points will be used for upper casts study and the measurements will be calculated using the Image J computer program To evaluate the movement of the anterior teeth we will project the incisive edge on the median line and measure the distance from this point to the projected position of the medial end of the third palatine wrinkle on the median line
To evaluate the movement of the first molars we will project the mesial contact point of the first molar on the median line and measure the distance from this point to the to the projected position of the medial end of the third palatine wrinkle on the median line
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