Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05655169
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2022-11-20
Brief Title:
Which is Better Piezosurgery or Piezosurgery With Laser in Accelerating Orthodontic Tooth Movement
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Effectiveness of Piezocision or the Combination of Piezocision and Low-level Laser Therapy on Orthodontic Tooth Movement During En-masse Retraction and the Associated Dentoalveolar Changes A Three-arm Randomized Controlled 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:
Sixty patients who need extraction-based treatment of the maxillary first premolars with subsequent retraction of the maxillary anterior teeth will be divided randomly into three groups piezocision group piezocision with low-level laser therapy group and control group In each group after the levelling and alignment phase is completed the rectangular stainless steel archwires 0019 0025 will be inserted then after two weeks the en masse retraction will be started via closed nickel-titanium coil springs applying 250 g of force per side For anchorage mini implants will be inserted between the second premolars and the first molar on each side
Detailed Description:
Regarding the Piezocision vertical soft-tissue incisions will be made on the buccal and palatal gingiva One incision will be made between the roots of the six upper anterior teeth and two incisions will be made between the upper canines and the second premolars The incisions will be 5 mm long and start 4 mm apical to the interdental papilla Then a piezosurgery knife will be inserted to perform the cortical alveolar incisions with 3-mm in-depth and 8 mm in length No suturing will be needed
Regarding the piezocision with the later application of low-level laser therapy LLLT
After six weeks of piezosurgery a diode laser wavelength 810 nm and exposure time of 10 secondspoint 10 seconds per point will be applied on each tooth of the six maxillary anterior teeth according to this protocol the root will be divided theoretically into two halves gingival and cervical and the laser will be applied in the center of each half from both buccal and palatal sides which means four application points and total energy of 16 Joules per tooth LLLT irradiation will be performed in the sixth week after the onset of mass retraction day 0 After that irradiation is repeated on days 3 7 and 14 then every two weeks until the class I canine relationship is achieved andor spaces lateral to incisors are closed
Regarding the piezocision with the later application of low-level laser therapy LLLT
After six weeks of piezosurgery a diode laser wavelength 810 nm and exposure time of 10 secondspoint 10 seconds per point will be applied on each tooth of the six maxillary anterior teeth according to this protocol the root will be divided theoretically into two halves gingival and cervical and the laser will be applied in the center of each half from both buccal and palatal sides which means four application points and total energy of 16 Joules per tooth LLLT irradiation will be performed in the sixth week after the onset of mass retraction day 0 After that irradiation is repeated on days 3 7 and 14 then every two weeks until the class I canine relationship is achieved andor spaces lateral to incisors are closed
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