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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03764189
Other study ID # CEBD-CU-2018-11-41
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2019
Est. completion date November 2020

Study information

Verified date December 2018
Source Cairo University
Contact Nashwa abdel m mohamed, master
Phone 01020271313
Email dr.nashwa_87@live.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 13
Est. completion date November 2020
Est. primary completion date November 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 30 Years
Eligibility 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.

Study Design


Intervention

Procedure:
microosteoperforation
small holes made using large round bur

Locations

Country Name City State
Egypt Cairo University Cairo Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

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. — View 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. — View Citation

Alikhani, M., et al. Micro-osteoperforations: minimally invasive accelerated tooth movement. in Seminars in Orthodontics. 2015. Elsevier

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

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. — View 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. — View 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. — View 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. — View Citation

Nicozisis, J., Accelerated Orthodontics With Alveocentesis. Princeton Orthodontics. Clin Orthod, 2012. 19: p. 1-4

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of En-masse retraction retracting six anterior teeth three to six months
Secondary Root resorption affecting the six anterior teeth. Amount of root volume loss analyzed through CBCT software three to six months
Secondary Tipping affecting the anterior teeth. Changes in angular measurements calculated through CBCT software three to six months
Secondary Extrusion of anterior teeth Linear measurement changes in the clinical height using CBCT three to six months
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