Clinical trial NCT03764189: Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction
Official title: Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class II Division 1 Malocclusion
Keywords: Accelerated tooth movement AND anterior segment retraction AND miniscrews AND microosteoperforation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 13
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: accelerated anterior teeth retraction with the help of microosteoperforation procedure and miniscrews.

Detailed description: the study contains 2 groups each contains 13 subjects, A control group (anterior segment retraction with the help of miniscrews) and an intervention group ( anterior segment retraction with the help of miniscrews and microosteoperforation)

Eligibility criteria: Inclusion Criteria:

* Females with an age ranging between 16-30 years.
* Malocclusion that requires bilateral extraction of the maxillary first premolars and anterior segment retraction; Angle class I mal-occlusion with bi-alveolar dental protrusions or class II division 1.
* Healthy dental and periodontal condition with a good oral hygiene
* Absence of degenerative conditions.
* Full set of permanent dentition.

Exclusion Criteria:

* Medically compromised patients.
* Previous orthodontic treatment
* Patients suffering from any congenital, hereditary or systemic diseases or asymmetries that might have an influence on tooth movement
* Chronic use of any medications affecting orthodontic tooth movement (eg: NSAIDs).
* Active periodontal affection or severe gingival inflammation.

Primary outcomes:
measure: Rate of En-masse retraction
timeFrame: three to six months
Secondary outcomes:
measure: Root resorption affecting the six anterior teeth.
timeFrame: three to six months
measure: Tipping affecting the anterior teeth.
timeFrame: three to six months
measure: Extrusion of anterior teeth
timeFrame: three to six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
affiliation: Cairo u
name: Mohamed A Kaddah, Phd
role: STUDY_DIRECTOR
References:
citation: McGorray SP, Dolce C, Kramer S, Stewart D, Wheeler TT. A randomized, placebo-controlled clinical trial on the effects of recombinant human relaxin on tooth movement and short-term stability. Am J Orthod Dentofacial Orthop. 2012 Feb;141(2):196-203. doi: 10.1016/j.ajodo.2011.07.024.
citation: Nicozisis, J., Accelerated Orthodontics With Alveocentesis. Princeton Orthodontics. Clin Orthod, 2012. 19: p. 1-4
citation: Collins MK, Sinclair PM. The local use of vitamin D to increase the rate of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1988 Oct;94(4):278-84. doi: 10.1016/0889-5406(88)90052-2.
citation: Blanco, J., et al., Efecto de la administración sistémica del 1, 25 Dihidrxicolecalciferol sobre la velocidad del movimiento ortodóncico en humanos. Estudio Clínico. Revista Odontos, 2001. 8: p. 13-21
citation: Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.
citation: Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial. Head Face Med. 2018 Feb 17;14(1):4. doi: 10.1186/s13005-018-0161-9.
citation: Alikhani, M., et al. Micro-osteoperforations: minimally invasive accelerated tooth movement. in Seminars in Orthodontics. 2015. Elsevier
citation: Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
citation: Ribeiro GL, Jacob HB. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment. Dental Press J Orthod. 2016 Mar-Apr;21(2):115-25. doi: 10.1590/2177-6709.21.2.115-125.sar.
citation: Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.