Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05920525
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2023-06-17
Brief Title:
Pain Discomfort and Acceptance During Using Electrical Stimulation to Accelerate Orthodontic Teeth Movement
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Evaluation of Patient-reported Outcome Measures PROMs During Accelerating the En-masse Retraction of Upper Anterior Teeth Using a Low-intensity Direct Electrical Current A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-06
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:
Forty patients with class II division 1 malocclusion who will require extraction of the upper first premolars as a part of the orthodontic treatment plan will be invited to participate in the study They will be divided randomly into two groups the electrical group and the control group The en-masse retraction technique will be used to retract the upper anterior teeth using mini-implants as an anchor unit to provide the maximum anchorage and Nickle-Titanium closed coil springs that will be stretched from the mini-implants to the crimpable hooks on the base wire and applied 250 g of force per side
A special removable electrical device will be used to provide electrical stimulation during the retraction phase
The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales
A special removable electrical device will be used to provide electrical stimulation during the retraction phase
The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales
Detailed Description:
Participants will be chosen from the patients attending the Department of Orthodontics in the Faculty of Dentistry at Damascus University patients will be examined by the researcher and any patient with class II division I malocclusion who meets the inclusion criteria will invite to participate in this trial After giving them the information sheet informed consent will be obtained from all patients who agreed to join the study
Leveling and alignment will be performed using pre-adjusted fixed orthodontic appliances of 0022 x 0028-inch slot metal bracket with MBT prescription the conventional wiring sequence will be followed until a 0019 x 0025 Stainless Steel base wire is attached
The maxillary first premolars will be extracted and skeletal anchoring will be applied before leveling and alignment will begin for all patients self-drilling orthodontic mini-implants diameter 16 mm length 8 mm will be placed between the roots of the maxillary second premolar and the first molar on each side
The en-masse retraction will be done using Nickle-Titanium NiTi closed coil springs that stretched from crimpable hooks on the base wire to the mini-implants and applied 250 g of force per side The force will be examined using a force gauge at every appointment two weeks until the completion of the retraction of the upper anterior reaching a class I canine relationship and a correct incisor relationship
A micro electrical current will be applied on the upper anterior teeth area using a removable intraorally device containing a small electrical circuit Each patient in the experimental group will be asked to apply the electric accelerating device in the mouth for 5 hours daily
The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales 24 hours following the springs activation T1 three days T2 and one week T3
Leveling and alignment will be performed using pre-adjusted fixed orthodontic appliances of 0022 x 0028-inch slot metal bracket with MBT prescription the conventional wiring sequence will be followed until a 0019 x 0025 Stainless Steel base wire is attached
The maxillary first premolars will be extracted and skeletal anchoring will be applied before leveling and alignment will begin for all patients self-drilling orthodontic mini-implants diameter 16 mm length 8 mm will be placed between the roots of the maxillary second premolar and the first molar on each side
The en-masse retraction will be done using Nickle-Titanium NiTi closed coil springs that stretched from crimpable hooks on the base wire to the mini-implants and applied 250 g of force per side The force will be examined using a force gauge at every appointment two weeks until the completion of the retraction of the upper anterior reaching a class I canine relationship and a correct incisor relationship
A micro electrical current will be applied on the upper anterior teeth area using a removable intraorally device containing a small electrical circuit Each patient in the experimental group will be asked to apply the electric accelerating device in the mouth for 5 hours daily
The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales 24 hours following the springs activation T1 three days T2 and one week T3
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