Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05652244
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2022-12-07
Brief Title:
Evaluation of the Levels of Pain Discomfort and Functional Impairment With Two Techniques of Retraction
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Evaluation of Pain Discomfort and Functional Impairment Associated With the Two-step Retraction Technique Anchored With Transpalatal Arches Versus the en Masse Retraction of Upper Anterior Teeth Anchored With Mini-implants A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-12
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 will participate in the study They will be divided randomly into two groups an en-masse retraction group and a two-step group In each group anterior teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side Mini-implants will be used as an anchor unit in the en-masse retraction group and TPA in the two-steps retraction group
The levels of pain discomfort and functional impairments will be self-reported using a validated questionnaire with a 4-points Likert scale
The levels of pain discomfort and functional impairments will be self-reported using a validated questionnaire with a 4-points Likert scale
Detailed Description:
Pain associated with orthodontic treatment is one of the undesirable complications which negatively affects the patients cooperation Pain may occur due to the pressure on the periodontal ligaments induced by orthodontic forces The perception of pain is affected by many factors related to the patient such as age gender and any previous treatment experiences which are negatively or positively reflected in the patients cooperation As for the factors related to the type of orthodontic treatment provided
The levels of pain and discomfort vary with the different anchorage systems used during orthodontic treatment
Several methods have been proposed to assure good anchorages such as headgear transpalatal arch TPA with or without a Nance button lingual arches bonding of second molars or intermaxillary elastics and recently mini-implants
The use of mini-implants has recently become more common The mini-implants have been used to secure absolute anchorage in en-mass retraction canine retraction total arch distalization and anterior teeth intrusion The most common usage is en-mass retraction of anterior teeth
The levels of pain and discomfort vary with the different anchorage systems used during orthodontic treatment
Several methods have been proposed to assure good anchorages such as headgear transpalatal arch TPA with or without a Nance button lingual arches bonding of second molars or intermaxillary elastics and recently mini-implants
The use of mini-implants has recently become more common The mini-implants have been used to secure absolute anchorage in en-mass retraction canine retraction total arch distalization and anterior teeth intrusion The most common usage is en-mass retraction of anterior teeth
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