drugset / Trial / NCT03582605
Antibiotics Prior to Mini-screw Implant Insertion
RandomizedParallel-groupTriple-blindPrevention
Summary
The investigators plan to use amoxicillin in capsule form, prepared by a pharmacist, for antibiotic prophylaxis to decrease the failure rate of mini-screw implants temporarily placed in the palate of patients involved in Phase II orthodontics treatments. The mini-screws will be 8 mm long 1.7 mm diameter titanium screws manufactured by Forestadent and are commercially available and currently widely used in orthodontic treatment in both private practice and educational settings. Since antibiotic prophylaxis is considered the standard of care with traditional dental implants, the investigators believe that such prophylaxis will decrease the failure rate of orthodontic mini-screw implants also.
Timeline
- Start
- 2018-08-07
- Primary completion
- 2020-10-01
- Completion
- 2020-11-01
Publications
- Background Berens A, Wiechmann D & Rudiger J. "L'ancrage intra-osseux en orthodontie a' l'aide de mini et de microvis." International Orthodontics (2005) 3: 235-43.
- Background Carano A, Melsen B. Implants in orthodontics. Interview. Prog Orthod. 2005;6(1):62-9. No abstract available. English, Italian.
- Background Cope J. "Temporary anchorage devices in orthodontics: a paradigm shift." Seminars in Orthodontics (2005)11:3-9.
- Background Costa A, Raffainl M, Melsen B. Miniscrews as orthodontic anchorage: a preliminary report. Int J Adult Orthodon Orthognath Surg. 1998;13(3):201-9.
- Background Esposito M, Grusovin MG, Worthington HV. Interventions for replacing missing teeth: antibiotics at dental implant placement to prevent complications. Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD004152. doi: 10.1002/14651858.CD004152.pub4.
- Background Esposito M, Hirsch JM, Lekholm U, Thomsen P. Biological factors contributing to failures of osseointegrated oral implants. (II). Etiopathogenesis. Eur J Oral Sci. 1998 Jun;106(3):721-64. doi: 10.1046/j.0909-8836..t01-6-.x.
- Background Flemmig TF & Newman MG. "Antimicrobials in implant dentistry." In: Newman MG, Kornman K editor. Antibiotics/antimicrobial use in dental practice. Chicago: Quintessence Publishing Co, Inc,(1990):187-200.
- Background Freudenthaler JW, Haas R, Bantleon HP. Bicortical titanium screws for critical orthodontic anchorage in the mandible: a preliminary report on clinical applications. Clin Oral Implants Res. 2001 Aug;12(4):358-63. doi: 10.1034/j.1600-0501.2001.012004358.x. English, French, German.
- Background Fritz U, Ehmer A, Diedrich P. Clinical suitability of titanium microscrews for orthodontic anchorage-preliminary experiences. J Orofac Orthop. 2004 Sep;65(5):410-8. doi: 10.1007/s00056-004-0408-x. English, German.
- Background Gray JB, Steen ME, King GJ, Clark AE. Studies on the efficacy of implants as orthodontic anchorage. Am J Orthod. 1983 Apr;83(4):311-7. doi: 10.1016/0002-9416(83)90226-9.
- Background Heymann GC, Tulloch JF. Implantable devices as orthodontic anchorage: a review of current treatment modalities. J Esthet Restor Dent. 2006;18(2):68-79; discussion 80. doi: 10.2310/6130.2006.00013_1.x.
- Background Kanomi R. Mini-implant for orthodontic anchorage. J Clin Orthod. 1997 Nov;31(11):763-7. No abstract available.
- Background Lee SJ, Ahn SJ, Lee JW, Kim SH, Kim TW. Survival analysis of orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):194-9. doi: 10.1016/j.ajodo.2008.03.031.
- Background Miyawaki S, Koyama I, Inoue M, Mishima K, Sugahara T, Takano-Yamamoto T. Factors associated with the stability of titanium screws placed in the posterior region for orthodontic anchorage. Am J Orthod Dentofacial Orthop. 2003 Oct;124(4):373-8. doi: 10.1016/s0889-5406(03)00565-1.
- Background Odman J, Lekholm U, Jemt T, Branemark PI, Thilander B. Osseointegrated titanium implants--a new approach in orthodontic treatment. Eur J Orthod. 1988 May;10(2):98-105. doi: 10.1093/ejo/10.2.98. No abstract available.
- Background Ohmae M, Saito S, Morohashi T, Seki K, Qu H, Kanomi R, Yamasaki KI, Okano T, Yamada S, Shibasaki Y. A clinical and histological evaluation of titanium mini-implants as anchors for orthodontic intrusion in the beagle dog. Am J Orthod Dentofacial Orthop. 2001 May;119(5):489-97. doi: 10.1067/mod.2001.114300.
- Background Papadopoulos MA, Tarawneh F. The use of miniscrew implants for temporary skeletal anchorage in orthodontics: a comprehensive review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e6-15. doi: 10.1016/j.tripleo.2006.11.022. Epub 2007 Feb 21.
- Background Prophylaxis in surgery. Veterans Administration Ad Hoc Interdisciplinary Advisory Committee on Antimicrobial Drug Usage. JAMA. 1977 Mar 7;237(10):1003-8. No abstract available.
- Background Reynders R, Ronchi L, Bipat S. Mini-implants in orthodontics: a systematic review of the literature. Am J Orthod Dentofacial Orthop. 2009 May;135(5):564.e1-19; discussion 564-5. doi: 10.1016/j.ajodo.2008.09.026.
- Background Roberts WE, Helm FR, Marshall KJ, Gongloff RK. Rigid endosseous implants for orthodontic and orthopedic anchorage. Angle Orthod. 1989 Winter;59(4):247-56. doi: 10.1043/0003-3219(1989)0592.0.CO;2.
- Background Roberts WE, Marshall KJ, Mozsary PG. Rigid endosseous implant utilized as anchorage to protract molars and close an atrophic extraction site. Angle Orthod. 1990 Summer;60(2):135-52. doi: 10.1043/0003-3219(1990)0602.0.CO;2.
- Background Roberts WE, Smith RK, Zilberman Y, Mozsary PG, Smith RS. Osseous adaptation to continuous loading of rigid endosseous implants. Am J Orthod. 1984 Aug;86(2):95-111. doi: 10.1016/0002-9416(84)90301-4.
- Background Sharaf B, Jandali-Rifai M, Susarla SM, Dodson TB. Do perioperative antibiotics decrease implant failure? J Oral Maxillofac Surg. 2011 Sep;69(9):2345-50. doi: 10.1016/j.joms.2011.02.095. Epub 2011 Jun 15.
- Background Wehrbein H, Merz BR. Aspects of the use of endosseous palatal implants in orthodontic therapy. J Esthet Dent. 1998;10(6):315-24. doi: 10.1111/j.1708-8240.1998.tb00510.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 50 mg/kg | Oral |
| Subject | Amoxicillin | Other / unclassified | 2 g | Oral |
Indications
No indication recorded.